Living well with chronic pain: a 12-month randomized controlled trial revealing impact from the digital pain self-management program EPIO.

Introduction: Chronic pain affects a wide range of physical and psychological aspects of life for those impacted. Psychosocial treatment approaches may be of support, but outreach is still limited. Objectives: To evaluate the efficacy of EPIO, an evidence-informed, user-centered digital self-management intervention for people with chronic pain, in a 12-month randomized controlled trial. Methods: People living with chronic pain (N = 266) were randomized to the EPIO intervention (n = 132) or a usual-care control group (n = 134). The intervention was delivered in a simple blended care model, and outcome measures collected at baseline, 6 months, and 12 months. Generalized linear models for repeated measures were fitted to compare groups over time. Results: Participants were primarily female (81%), median age 49 years (range 22-78), with heterogeneous pain conditions, and had lived with pain >5 years (77.6%). A mixed linear model with all timepoints included revealed no statistically significant group differences for the primary outcome of pain interference. Significant psychological benefits in favor of the intervention group were however detected for depression (P = 0.022), self-regulatory fatigue (P = 0.024), vitality (P = 0.016), and mental health (P = 0.047). Baseline to 12-month changes showed additional favorable effects for anxiety (between-group mean differences [MDs] = 0.79, P = 0.047), depression (MD = 1.08, P = 0.004), self-regulatory fatigue (MD = 2.42, P = 0.021), pain catastrophizing (MD = 2.62, P = 0.009), and health-related quality of life. Conclusions: The EPIO program aims to improve outreach of evidence-based pain self-management interventions. Findings demonstrate how using EPIO can lead to sustainable psychological change, enhancing mental health and health-related quality of life for people suffering from pain, providing a chance to live well with the pain.

Digital Cognitive Behavioral- and Mindfulness-Based Stress-Management Interventions for Survivors of Breast Cancer: Development Study.

BACKGROUND: Psychosocial stress-management interventions can reduce stress and distress and improve the quality of life for survivors of cancer. As these in-person interventions are not always offered or accessible, evidence-informed digital stress-management interventions may have the potential to improve outreach of psychosocial support for survivors of cancer. Few such digital interventions exist so far, few if any have been developed specifically for survivors of breast cancer, and few if any have attempted to explore more than 1 distinct type of intervention framework. OBJECTIVE: This study aimed to develop 2 digital psychosocial stress-management interventions for survivors of breast cancer; 1 cognitive behavioral therapy-based intervention (CBI), and 1 mindfulness-based intervention (MBI). METHODS: The development of the CBI and MBI interventions originated from the existing StressProffen program, a digital stress-management intervention program for survivors of cancer, based on a primarily cognitive behavioral therapeutic concept. Development processes entailed a multidisciplinary design approach and were iteratively conducted in close collaboration between key stakeholders, including experts within psychosocial oncology, cancer epidemiology, stress-management, and eHealth as well as survivors of breast cancer and health care providers. Core psychosocial oncology stress-management and cancer epidemiology experts first conducted a series of workshops to identify cognitive behavioral and mindfulness specific StressProffen content, overlapping psychoeducational content, and areas where development and incorporation of new material were needed. Following the program content adaptation and development phase, phases related to user testing of new content and technical, privacy, security, and ethical aspects and adjustments ensued. Intervention content for the distinct CBI and MBI interventions was refined in iterative user-centered design processes and adjusted to electronic format through stakeholder-centered iterations. RESULTS: For the CBI version, the mindfulness-based content of the original StressProffen was removed, and for the MBI version, cognitive behavioral content was removed. Varying degrees of new content were created for both versions, using a similar layout as for the original StressProffen program. New content and new exercises in particular were tested by survivors of breast cancer and a project-related editorial team, resulting in subsequent user centered adjustments, including ensuring auditory versions and adequate explanations before less intuitive sections. Other improvements included implementing a standard closing sentence to round off every exercise, and allowing participants to choose the length of some of the mindfulness exercises. A legal disclaimer and a description of data collection, user rights and study contact information were included to meet ethical, privacy, and security requirements. CONCLUSIONS: This study shows how theory specific (ie, CBI and MBI) digital stress-management interventions for survivors of breast cancer can be developed through extensive collaborations between key stakeholders, including scientists, health care providers, and survivors of breast cancer. Offering a variety of evidence-informed stress-management approaches may potentially increase interest for outreach and impact of psychosocial interventions for survivors of cancer. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/47195.

Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial.

BACKGROUND: Chronic pain conditions involve numerous physical and psychological challenges, and while psychosocial self-management interventions can be of benefit for people living with chronic pain, such in-person treatment is not always accessible. Digital self-management approaches could improve this disparity, potentially bolstering outreach and providing easy, relatively low-cost access to pain self-management interventions. OBJECTIVE: This randomized controlled trial aimed to evaluate the short-term efficacy of EPIO (ie, inspired by the Greek goddess for the soothing of pain, Epione), a digital self-management intervention, for people living with chronic pain. METHODS: Patients (N=266) were randomly assigned to either the EPIO intervention (n=132) or a care-as-usual control group (n=134). Outcome measures included pain interference (Brief Pain Inventory; primary outcome measure), anxiety and depression (Hospital Anxiety and Depression Scale), self-regulatory fatigue (Self-Regulatory Fatigue 18 scale), health-related quality of life (SF-36 Short Form Health Survey), pain catastrophizing (Pain Catastrophizing Scale), and pain acceptance (Chronic Pain Acceptance Questionnaire). Linear regression models used change scores as the dependent variables. RESULTS: The participants were primarily female (210/259, 81.1%), with a median age of 49 (range 22-78) years and a variety of pain conditions. Analyses (n=229) after 3 months revealed no statistically significant changes for the primary outcome of pain interference (P=.84), but significant reductions in the secondary outcomes of depression (mean difference -0.90; P=.03) and self-regulatory fatigue (mean difference -2.76; P=.008) in favor of the intervention group. No other statistically significant changes were observed at 3 months (all P>.05). Participants described EPIO as useful (ie, totally agree or agree; 95/109, 87.2%) and easy to use (101/109, 92.7%), with easily understandable exercises (106/109, 97.2%). CONCLUSIONS: Evidence-informed, user-centered digital pain self-management interventions such as EPIO may have the potential to effectively support self-management and improve psychological functioning in the form of reduced symptoms of depression and improved capacity to regulate thoughts, feelings, and behavior for people living with chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

The Caregiver Pathway, a Model for the Systematic and Individualized Follow-up of Family Caregivers at Intensive Care Units: Development Study.

BACKGROUND: Family caregivers of patients who are critically ill have a high prevalence of short- and long-term symptoms, such as fatigue, anxiety, depression, symptoms of posttraumatic stress, and complicated grief. These adverse consequences following a loved one's admission to an intensive care unit (ICU) are also known as post-intensive care syndrome-family. Approaches such as family-centered care provide recommendations for improving the care of patients and families, but models for family caregiver follow-up are often lacking. OBJECTIVE: This study aims to develop a model for structuring and individualizing the follow-up of family caregivers of patients who are critically ill, starting from the patients' ICU admission to after their discharge or death. METHODS: The model was developed through a participatory co-design approach using a 2-phased iterative process. First, the preparation phase included a meeting with stakeholders (n=4) for organizational anchoring and planning, a literature search, and interviews with former family caregivers (n=8). In the subsequent development phase, the model was iteratively created through workshops with stakeholders (n=10) and user testing with former family caregivers (n=4) and experienced ICU nurses (n=11). RESULTS: The interviews revealed how being present with the patient and receiving adequate information and emotional care were highly important for family caregivers at an ICU. The literature search underlined the overwhelming and uncertain situation for the family caregivers and identified recommendations for follow-up. On the basis of these recommendations and findings from the interviews, workshops, and user testing, The Caregiver Pathway model was developed, encompassing 4 steps: within the first few days of the patient's ICU stay, the family caregivers will be offered to complete a digital assessment tool mapping their needs and challenges, followed by a conversation with an ICU nurse; when the patient leaves the ICU, a card containing information and support will be handed out to the family caregivers; shortly after the ICU stay, family caregivers will be offered a discharge conversation by phone, focusing on how they are doing and whether they have any questions or concerns; and within 3 months after the ICU stay, an individual follow-up conversation will be offered. Family caregivers will be invited to talk about memories from the ICU and reflect upon the ICU stay, and they will also be able to talk about their current situation and receive information about relevant support. CONCLUSIONS: This study illustrates how existing evidence and stakeholder input can be combined to create a model for family caregiver follow-up at an ICU. The Caregiver Pathway can help ICU nurses improve family caregiver follow-up and aid in promoting family-centered care, potentially also being transferrable to other types of family caregiver follow-up.

Patient-centered development of Embrace Pain: an online acceptance and commitment therapy intervention for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy.

BACKGROUND: Around 30% of cancer survivors suffer from chemotherapy-induced peripheral neuropathy (CIPN) ≥6 months after completion of chemotherapy, which comes with limitations in daily functioning and worsened quality of life(QoL). Treatment options are scarce. Our aim was to develop an online self-help intervention based on Acceptance and Commitment Therapy (ACT) to reduce pain interference in cancer survivors experiencing painful chronic CIPN. MATERIAL AND METHODS: This article applied a patient-centered design process using the Center for eHealth Research (CeHRes) roadmap. User needs were examined using online semi-structured interviews with patients and experts (N = 23). Interviews were transcribed verbatim and analyzed using thematic analysis. Personas were created based on interviews. Intervention content was based on identified user needs and ACT. Content and design were finalized using low-fidelity prototype testing (N = 5), and high-fidelity prototype testing (N = 7). RESULTS: Patients appreciated and agreed with the elements of ACT, had varying guidance needs, and wanted to have autonomy (e.g., moment and duration of use). Additionally, it was important to be aware that patients have had a life-threatening disease which directly relates to the symptoms they experience. Patients reported to prefer a user-friendly and accessible intervention. Similar points also emerged in the expert interviews. The final intervention, named Embrace Pain, includes six sessions. Session content is based on psychoeducation and all ACT processes. Further interpretation of the intervention (such as quotes, guidance, and multimedia choices) is based on the interviews. CONCLUSION: This development demonstrated how a patient-centered design process from a theoretical framework can be applied. Theory-driven content was used as the basis of the intervention. Findings show an online ACT intervention designed for cancer survivors with painful chronic CIPN.

Combining Persuasive System Design Principles and Behavior Change Techniques in Digital Interventions Supporting Long-term Weight Loss Maintenance: Design and Development of eCHANGE.

BACKGROUND: Long-term weight maintenance after weight loss is challenging, and innovative solutions are required. Digital technologies can support behavior change and, therefore, have the potential to be an effective tool for weight loss maintenance. However, to create meaningful and effective digital behavior change interventions that support end user values and needs, a combination of persuasive system design (PSD) principles and behavior change techniques (BCTs) might be needed. OBJECTIVE: This study aimed to investigate how an evidence-informed digital behavior change intervention can be designed and developed by combining PSD principles and BCTs into design features to support end user values and needs for long-term weight loss maintenance. METHODS: This study presents a concept for how PSD principles and BCTs can be translated into design features by combining design thinking and Agile methods to develop and deliver an evidence-informed digital behavior change intervention aimed at supporting weight maintenance. Overall, 45 stakeholders participated in the systematic and iterative development process comprising co-design workshops, prototyping, Agile development, and usability testing. This included prospective end users (n=17, 38%; ie, people with obesity who had lost ≥8% of their weight), health care providers (n=9, 20%), healthy volunteers (n=4, 9%), a service designer (n=1, 2%), and stakeholders from the multidisciplinary research and development team (n=14, 31%; ie, software developers; digital designers; and eHealth, behavior change, and obesity experts). Stakeholder input on how to operationalize the design features and optimize the technology was examined through formative evaluation and qualitative analyses using rapid and in-depth analysis approaches. RESULTS: A total of 17 design features combining PSD principles and BCTs were identified as important to support end user values and needs based on stakeholder input during the design and development of eCHANGE, a digital intervention to support long-term weight loss maintenance. The design features were combined into 4 main intervention components: Week Plan, My Overview, Knowledge and Skills, and Virtual Coach and Smart Feedback System. To support a healthy lifestyle and continued behavior change to maintain weight, PSD principles such as tailoring, personalization, self-monitoring, reminders, rewards, rehearsal, praise, and suggestions were combined and implemented into the design features together with BCTs from the clusters of goals and planning, feedback and monitoring, social support, repetition and substitution, shaping knowledge, natural consequences, associations, antecedents, identity, and self-belief. CONCLUSIONS: Combining and implementing PSD principles and BCTs in digital interventions aimed at supporting sustainable behavior change may contribute to the design of engaging and motivating interventions in line with end user values and needs. As such, the design and development of the eCHANGE intervention can provide valuable input for future design and tailoring of evidence-informed digital interventions, even beyond digital interventions in support of health behavior change and long-term weight loss maintenance. TRIAL REGISTRATION: ClinicalTrials.gov NCT04537988; https://clinicaltrials.gov/ct2/show/NCT04537988.

Feasibility of a Digital Patient-Provider Communication Intervention to Support Shared Decision-Making in Chronic Health Care, InvolveMe: Pilot Study.

BACKGROUND: Enhanced communication with health care providers (HCPs) can improve symptom management and health-related quality of life (HRQoL) for patients with chronic health conditions. Access to appropriate communication venues is needed to improve communication, however. As such, digital communication interventions mediated by patient portals carry the potential to support patient-provider communication and interaction and through this, also facilitate shared decision-making (SDM). The InvolveMe intervention was designed to provide patients with the opportunity to communicate symptoms and informational needs prior to consultation via digital assessment, including prioritizing what is most important to discuss with their HCPs, as well as to interact with HCPs through secure messages between outpatient visits. OBJECTIVE: The aim of this study was to assess the feasibility of the InvolveMe intervention by investigating acceptability, demand (ie, system use), and limited efficacy. METHODS: The study was designed as a single-arm, pre-post feasibility study combining quantitative and qualitative methods for data collection. Patients from an endocrine outpatient clinic were invited to use the InvolveMe intervention for 3 months, and HCPs administering InvolveMe were invited to participate in a focus group. Guided by descriptions of how to design feasibility studies by Bowen et al, feasibility was tested by exploring (1) acceptability, using data collected during recruitment from patient participants and nonparticipants (ie, declined to participate or did not meet study requirements), HCP experiences with recruitment, and the System Usability Scale (SUS); (2) demand via exploration of system use through extraction of system log data and HCP experiences with system use; and (3) limited efficacy testing, via exploration of potential effects from the Short-Form Health Survey (RAND 36), Hospital Anxiety and Depression Scale, and Health Literacy Questionnaire. RESULTS: Patient participants (N=23) were a median 54 (range 26-78) years old and primarily male (14/23, 61%). Nonparticipants (N=16) were a median 73 (range 55-80) years old and primarily male (12/16, 75%). The average SUS score was 72.2, indicating good system usability. Assessments were completed by 8 participants from home prior to outpatient visits. The assessments entailed various bodily symptoms and needs for information. Participants sent 17 secure messages related to patient administrative matters, symptoms, and challenges. Focus group participants (N=4) were all female and registered nurses. Data were analyzed in 2 predefined themes: Acceptability and Demand. Acceptability included the subthemes intervention attractiveness and intervention suitability. Demand included the subthemes elements of SDM and intervention challenges and opportunities. All patient participants completed outcome measures at baseline, and 19 (19/23, 83%) completed outcome measures at 3 months. These preliminary efficacy findings were mixed and inconclusive. CONCLUSIONS: The study design provided findings from both patient and HCP perspectives and supported feasibility of the InvolveMe intervention. The investigation of acceptability and demand supported the potential for remote SDM mediated by patient portals using assessments and secure messages. TRIAL REGISTRATION: ClinicalTrials.gov NCT NCT04218721; https://www.clinicaltrials.gov/ct2/show/NCT04218721.

Patients' Experiences of Using an eHealth Pain Management Intervention Combined With Psychomotor Physiotherapy: Qualitative Study.

BACKGROUND: Chronic pain is a major health challenge to those affected. Blended care with psychomotor physiotherapy (PMP) combined with eHealth self-management might be beneficial. OBJECTIVE: This study aims to explore how patients with chronic pain experience the combination of PMP and the use of EPIO, an eHealth self-management intervention for chronic pain. METHODS: Individual semistructured interviews were conducted with 5 adult patients with chronic pain (ie, participants) who used EPIO in combination with PMP over a period of 10 to 15 weeks. Interviews explored participants' experiences using this treatment combination in relation to their pain and analyzed their experiences using systematic text condensation. RESULTS: Participants described having benefited from using EPIO in combination with PMP in terms of increased awareness of bodily signals and how pain was related to stress and activity. They also described changes in the relationship to themselves in terms of increased self-acceptance, self-assertion, and hope and their relationship to their pain in terms of seeing pain as less harmful and engaging in more active coping strategies. CONCLUSIONS: Results indicate that a blended care approach combining eHealth self-management interventions such as EPIO with PMP may be of value to patients living with chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

Digital stress management in cancer: Testing StressProffen in a 12-month randomized controlled trial.

BACKGROUND: Cognitive-behavioral stress management interventions are associated with improved psychological well-being for cancer survivors. The availability of, access to, and outreach of these in-person interventions are limited, however. The current study, therefore, evaluated the efficacy of StressProffen, a digital application (app)-based stress management intervention for cancer survivors, in a 12-month randomized controlled trial. METHODS: Cancer survivors 1 year or less after their treatment (N = 172) were randomized to the StressProffen intervention (n = 84) or a usual-care control group (n = 88). The intervention was delivered in a simple blended care model: 1) 1 in-person introduction session, 2) 10 app-based cognitive-behavioral stress management modules, and 3) 2 follow-up phone calls. Stress (Perceived Stress Scale), anxiety and depression (Hospital Anxiety and Depression Scale), self-regulatory fatigue (Self-Regulatory Fatigue 18), and health-related quality of life (HRQOL; RAND-36) were examined at the baseline and at 6 and 12 months. Generalized linear models for repeated measures were fitted to compare effects over time. RESULTS: Participants were mainly female (82%), had a mean age of 52 years (standard deviation, 11.3 years; range, 20-78 years), and had a variety of cancer types (mostly breast cancer [48%]). Over the 12-month study time, the intervention group reported significantly decreased stress (P < .001), depression (P = .003), and self-regulatory fatigue (P = .002) as well as improved HRQOL (for 6 of 8 domains, P ≤ .015) in comparison with controls. The largest favored effects for the intervention group were observed at 6 months: stress (estimated mean difference [MD], -5.1; P < .001), anxiety (MD, -1.4; P = .015), depression (MD, -2.1; P < .001), self-regulatory fatigue (MD, -4.9; P < .001), and HRQOL (7 of 8 domains; P ≤ .037). CONCLUSIONS: Digital stress management interventions such as StressProffen have the potential to extend the outreach of psychological interventions and provide easily available and effective psychosocial support for cancer survivors.

Evaluating a Strengths-Based mHealth Tool (MyStrengths): Explorative Feasibility Trial.

BACKGROUND: As the number of people living with chronic illnesses increases, providing wide-reaching and easy-to-use support tools is becoming increasingly important. Supporting people in this group to recognize and use more of their personal strengths has the potential to improve their quality of life. With this in mind, we have developed the MyStrengths app prototype, a gamefully designed app aimed at aiding users in both identifying their strengths and using these strengths more actively in their daily life. OBJECTIVE: The goal of this study was to evaluate the user-reported feasibility and usefulness of the MyStrengths app. The study additionally aimed to explore whether the use of MyStrengths could be associated with selected psychosocial outcomes. METHODS: A 31-day explorative feasibility trial with a pretest-posttest design and an optional end of study interview was conducted. Data collection included system-use log data, demographic information, pre- and post-psychosocial measures (ie, strengths use, self-efficacy, health-related quality of life, depression), user experience measures (ie, usability, engagement, flow), and interview data. RESULTS: In total, 34 people with at least 1 chronic condition were enrolled in the study, with 26 participants (mean age 48 years, range 29-62 years; 1 male) completing the trial. Among these individuals, 18 were also interviewed posttrial. Participants used the MyStrengths app an average of 6 days during the trial period, with 54% (14/26) using the app over a period of at least 19 days. In total, 8738 unique app actions were registered. Of the psychosocial outcome measures, only 1 subscale, general health in the RAND 36-Item Health Survey, yielded significant pre- and posttest changes. Posttrial interviews showed that the number of participants who considered the MyStrengths app to be useful, somewhat useful, or not useful was evenly distributed across 3 groups. However, every participant did voice support for the strengths approach. All participants were able to identify a multitude of personal strengths using the MyStrengths app. Most participants that reported it to be useful had little or no previous experience with the personal strengths approach. A multitude of users welcomed the gameful design choices, particularly the rolling die feature, suggesting strengths exercises, activities that use a specific strength, were well received. CONCLUSIONS: Although the reported usefulness and feedback from use varied, most participants were favorable to the strengths-focused approach to care and support. Consequently, low-threshold and wide-reaching mobile health tools that use a strengths-focused approach, such as MyStrengths, hold the potential to support people living with chronic illness in performing self-management and achieving mastery of their life.

A Digital Patient-Provider Communication Intervention (InvolveMe): Qualitative Study on the Implementation Preparation Based on Identified Facilitators and Barriers.

BACKGROUND: Chronic health conditions are affecting an increasing number of individuals, who experience various symptoms that decrease their quality of life. Digital communication interventions that enable patients to report their symptoms have been shown to positively impact chronic disease management by improving access to care, patient-provider communication, clinical outcomes, and health-related quality of life. These interventions have the potential to prepare patients and health care providers (HCPs) before visits and improve patient-provider communication. Despite the recent rapid development and increasing number of digital communication interventions that have shown positive research results, barriers to realizing the benefits offered through these types of interventions still exist. OBJECTIVE: The aim of this study is to prepare for the implementation of a digital patient-provider communication intervention in the daily workflow at 2 outpatient clinics by identifying potential determinants of implementation using the Consolidated Framework for Implementation Research (CFIR) to tailor the use of digital communication intervention to the intended context and identify key aspects for an implementation plan. METHODS: A combination of focus groups, workshops, and project steering committee meetings was conducted with HCPs (n=14) and patients (n=2) from 2 outpatient clinics at a university hospital. The CFIR was used to guide data collection and analysis. Transcripts, written minutes, and notes were analyzed and coded into 5 CFIR domains using thematic analysis. RESULTS: Data were examined and analyzed into 18 CFIR constructs relevant to the study purpose. On the basis of the identified determinants, important intervention tailoring includes adjustments to the digital features and adjustments to fit the clinical workflow and a decision to conduct a future pilot study. Furthermore, it was decided to provide the intervention to patients as early as possible in their disease trajectory, with tailored information about its use. Key aspects for the implementation plan encompassed maintaining the identified engagement and positive attitude, involving key stakeholders in the implementation process, and providing the needed support and training. CONCLUSIONS: This study offers insight into the involvement of stakeholders in the tailoring and implementation planning of a digital communication intervention in clinical practice. Stakeholder involvement in the identification of implementation facilitators and barriers can contribute to the tailoring of digital communication interventions and how they are used and can also inform systematic and targeted implementation planning.

Video as an alternative to in-person consultations in outpatient renal transplant recipient follow-up: a qualitative study.

BACKGROUND: Renal transplant recipients have to see a nephrologist for regular follow-up for the rest of their lives. To reduce the burden for the patients, video consultation can be an alternative to traditional in-person hospital consultations. The aim of the current study was, from the perspectives of patients and health care providers, to investigate the perceived benefits and challenges of using video consultations in outpatient renal transplant recipient follow-up. METHODS: Patients (i.e., renal transplant recipients; n = 18) alternated between regular in-person follow-up consultations and video consultations. Patients and health care providers were then invited to participate in semi-structured interviews. The interviews were analyzed using thematic analysis. RESULTS: Patients interviewed (n = 15) were median 53 years old (range 37-64) and 53% female. The video consultation solution used in the study turned out to have major technical deficiencies. Despite the technical challenges, however, the majority of the patients reported appreciating being able to alternate between video and in-person hospital consultations. Main benefits reported included not needing to travel to the hospital and thereby saving time, less focus on being chronically ill and potential economic benefits for patients and society. The health care providers (n = 3) also valued the benefits provided by the use of video consultations, but described the reoccurring technical challenges as disruptive. The fact that patients were in a stable phase of their health condition and already had an established, trusting relationship with their nephrologist, acted as facilitators for success. Possible challenges and harms described included concerns related to security, confidentiality and interruptions, as well as the potential need for physical examinations. CONCLUSIONS: Benefits from using video consultations as an alternative to in-person consultations may outweigh potential technological challenges for patients as well as health care providers. A long-lasting mutually trusting relationship between patient and provider may be an important prerequisite for the experienced benefits of using video consultation. Findings also indicate that starting such care delivery changes in a small-scale, with a few selected patients in a stable phase of their condition, may be an important factor for success.

Health care providers' experiences of pain management and attitudes towards digitally supported self-management interventions for chronic pain: a qualitative study.

BACKGROUND: Chronic pain constitutes a significant burden for the individuals affected, and is a frequent reason why patients seek health care services. While in-person psychosocial interventions can be of support to people living with chronic pain, such interventions are not always accessible. eHealth interventions may provide greater accessibility, but the evidence and use of digital self-management solutions for chronic pain are still limited and the lack of health care provider input in the development process of such solutions a concern. Therefore, the aim of the current study was to investigate health care providers' experiences of treating patients with chronic pain, their attitudes towards, and use of, digital solutions in pain management, and their suggestions for content and design elements for a potential digital pain self-management intervention. METHODS: Twelve health care providers representing a variety of health care disciplines participated in semi-structured interviews. The interviews were analyzed using thematic analysis. RESULTS: The material was analyzed into three main themes: [1] Patients with chronic pain and their current use of the health care services, [2] Health care providers' own motivation and impression of patient prerequisites for use of digital self-management interventions, and [3] Suggestions for content and design elements in a digital self-management intervention for people living with chronic pain. The challenges faced by patients living with chronic pain were described as numerous. Despite interest and positive attitudes, few of the health care providers had used or recommended eHealth solutions to their patients. A range of potential content and functionality elements were identified, including aspects of motivation and engagement and providers also emphasized the importance of easy access and positive, personal content to support existing treatment. CONCLUSIONS: This study offers insights into health care providers' considerations for the potential of digital self-management interventions supporting patients living with chronic pain. Findings indicate the need for change and a more comprehensive treatment approach to pain management. eHealth solutions may contribute to such change, and providers pointed to a need for health care provider involvement, timely support and follow-up as important factors for integrating digital pain self-management interventions into clinical care. TRIAL REGISTRATION: ClinicalTrials.gov : NCT03705104.

Identifying Persuasive Design Principles and Behavior Change Techniques Supporting End User Values and Needs in eHealth Interventions for Long-Term Weight Loss Maintenance: Qualitative Study.

BACKGROUND: An increasing number of eHealth interventions aim to support healthy behaviors that facilitate weight loss. However, there is limited evidence of the effectiveness of the interventions and little focus on weight loss maintenance. Knowledge about end user values and needs is essential to create meaningful and effective eHealth interventions, and to identify persuasive system design (PSD) principles and behavior change techniques (BCTs) that may contribute to the behavior change required for successful long-term weight loss maintenance. OBJECTIVE: This study aimed to provide insight into the design of eHealth interventions supporting behavior change for long-term weight maintenance. The study sought to identify the values and needs of people with obesity aiming to maintain weight after weight loss, and to identify PSD principles, BCTs, and design requirements that potentially enable an eHealth intervention to meet end user values and needs. METHODS: This study presents the concept of integrating PSD principles and BCTs into the design process of eHealth interventions to meet user values and needs. In this study, individual interviews and focus groups were conducted with people with obesity (n=23) and other key stakeholders (n=27) to explore end user values and needs related to weight loss maintenance. Design thinking methods were applied during the focus group sessions to identify design elements and to explore how eHealth solutions can support the needs to achieve sustainable weight loss maintenance. The PSD model and behavior change taxonomy by Michie were used to identify PSD principles and BCT clusters to meet end user values and needs. RESULTS: A total of 8 key end user values were identified, reflecting user needs for weight loss maintenance support: self-management, personalized care, autonomy, feel supported, positive self-image, motivation, happiness, and health. Goals and planning, feedback and monitoring, repetition and substitution, shaping knowledge, social support, identity, and self-belief were some of the BCT clusters identified to address these concepts, together with PSD principles such as personalization, tailoring, self-monitoring, praise, and suggestions. CONCLUSIONS: The process of translating end user values and needs into design elements or features of eHealth technologies is an important part of the design process. To our knowledge, this is the first study to explore how PSD principles and BCTs can be integrated when designing eHealth self-management interventions for long-term weight loss maintenance. End users and other key stakeholders highlighted important factors to be considered in the design of eHealth interventions supporting sustained behavior change. The PSD principles and BCTs identified provide insights and suggestions about design elements and features to include for supporting weight loss maintenance. The findings indicate that a combination of BCTs and PSD principles may be needed in evidence-based eHealth interventions to stimulate motivation and adherence to support healthy behaviors and sustained weight loss maintenance. TRIAL REGISTRATION: ClinicalTrials.gov NCT04537988; https://clinicaltrials.gov/ct2/show/NCT04537988.

Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study.

BACKGROUND: Chronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients' daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed. OBJECTIVE: This feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain. METHODS: The EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior-based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire. RESULTS: Participants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, "totally agree" or "agree"; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049). CONCLUSIONS:  Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress. TRIAL REGISTRATION: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

Results from a randomized controlled trial testing StressProffen; an application-based stress-management intervention for cancer survivors.

BACKGROUND: In-person cognitive-behavioral stress-management interventions are consistently associated with reduced cancer distress. However, face-to-face delivery is an access barrier for many patients, and there is a need to develop remote-delivered interventions. The current study evaluated the preliminary efficacy of an application (app)-based cancer stress-management intervention, StressProffen, in a randomized controlled trial. METHODS: Cancer survivors, maximum 1-year posttreatment (N = 172), were randomized to StressProffen (n = 84) or a usual care control group (n = 88). Participants received a blended delivery care model: (a) one face-to-face introduction session, (b) 10 app-based cognitive-behavioral stress-management modules, and (c) follow-up phone calls at weeks 2-3 and 6-7. Outcome measures included stress (Perceived Stress Scale), anxiety and depression (Hospital Anxiety Depression Scale), and health-related quality of life (HRQoL; Short-Form Health Surveys [SF-36]) at 3-months post-intervention, analyzed with change scores as dependent variables in linear regression models. RESULTS: Participants were primarily women (82%), aged 20-78 years (mean 52, SD 11.2), with mixed cancer types (majority breast cancer; 48%). Analysis of 149 participants completing questionnaires at baseline and 3 months revealed significant intervention effects: decreased stress (mean difference [MD] -2.8; 95% confidence interval [CI], [-5.2 to -0.4]; P = .022) and improved HRQoL (Role Physical MD = 17.7, [CI 3.7-31.3], P = .013; Social Functioning MD = 8.5, [CI 0.7-16.2], P = .034; Role Emotional MD = 19.5, [CI 3.7-35.2], P = .016; Mental Health MD = 6.7, [CI 1.7-11.6], P = .009). No significant changes were observed for anxiety or depression. CONCLUSIONS: Digital-based cancer stress-management interventions, such as StressProffen, have the potential to provide easily accessible, effective psychosocial support for cancer survivors.

Content and system development of a digital patient-provider communication tool to support shared decision making in chronic health care: InvolveMe.

BACKGROUND: Chronic conditions present major health problems, affecting an increasing number of individuals who experience a variety of symptoms that impact their health related quality of life. Digital tools can be of support in chronic conditions, potentially improving patient-provider communication, promoting shared decision making for treatment and care, and possibly even improving patient outcomes. This study aimed to develop a digital tool for patient-provider communication in chronic health care settings and describes the data collection and subsequent content and software development of the InvolveMe tool. InvolveMe will provide patients with the opportunity to report symptoms and preferences to their health care providers (HCP), and to use secure messaging to interact with the HCPs. METHOD: The study employed a combination of interviews with patients with chronic conditions and focus groups with HCPs, examining experiences with chronic conditions and the potential use of a digital tool for support. Participants were recruited from two outpatient clinics at a university hospital. Data collected from interviews and focus groups were analysed using thematic analysis. Content and software development was informed by the data collection and by tool development workshops. RESULTS: Analyses from interviews with patients (n = 14) and focus groups with HCPs (n = 11) generated three main themes: 1) Making symptoms and challenges visible, 2) Mastering a new life, and 3) Digital opportunities for follow-up. Each main theme generated separate subthemes. Theme 1 and 2 gave input for content development of the symptom and needs assessment part of the tool, while theme 3 provided ideas for the software development of the InvolveMe tool. Tool development workshops with patients (n = 6) and HCPs (n = 6) supplemented the development. CONCLUSIONS: A digital tool such as InvolveMe has the potential to support shared decision making for patients with chronic health conditions. Through integration with an existing patient portal such a tool can provide opportunities for meaningful interactions and communication between patients and HCP's, particularly with regards to symptoms, needs and preferences for care.

A User-Centered Approach to an Evidence-Based Electronic Health Pain Management Intervention for People With Chronic Pain: Design and Development of EPIO.

BACKGROUND: Chronic pain conditions are complicated and challenging to live with. Electronic health (eHealth) interventions show promise in helping people cope with chronic illness, including pain. The success of these interventions depends not only on the technology and intervention content but also on the users' acceptance and adherence. Involving all stakeholders (eg, patients, spouses, health care providers, designers, software developers, and researchers) and exploring their input and preferences in the design and development process is an important step toward developing meaningful interventions and possibly strengthening treatment outcomes. OBJECTIVE: The aim of this study was to design and develop a user-centered, evidence-based eHealth self-management intervention for people with chronic pain. METHODS: The study employed a multidisciplinary and user-centered design approach. Overall, 20 stakeholders from the project team (ie, 7 researchers, 5 editors, 7 software developers, and 1 user representative), together with 33 external stakeholders (ie, 12 health care providers, 1 health care manger, 1 eHealth research psychologist, and 17 patients with chronic pain and 2 of their spouses) participated in a user-centered development process that included workshops, intervention content development, and usability testing. Intervention content was developed and finalized based on existing evidence, stakeholder input, and user testing. Stakeholder input was examined through qualitative analyses with rapid and in-depth analysis approaches. RESULTS: Analyses from stakeholder input identified themes including a need for reliable, trustworthy, and evidence-based content, personalization, options for feedback, behavioral tracking, and self-assessment/registration as factors to include in the intervention. Evidence-based intervention content development resulted in one face-to-face introduction session and 9 app-based educational and exercise-based modules. Usability testing provided further insight into how to optimize the design of the intervention to the user group, identifying accessibility and a simple design to be essential. CONCLUSIONS: The design and development process of eHealth interventions should strive to combine well-known evidence-based concepts with stakeholder input. This study, designing and developing the pain management intervention EPIO, illustrates how a stakeholder-centered design approach can provide essential input in the development of an eHealth self-management intervention for people with chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

Implementation Strategies to Enhance the Implementation of eHealth Programs for Patients With Chronic Illnesses: Realist Systematic Review.

BACKGROUND: There is growing evidence of the positive effects of electronic health (eHealth) interventions for patients with chronic illness, but implementation of such interventions into practice is challenging. Implementation strategies that potentially impact implementation outcomes and implementation success have been identified. Which strategies are actually used in the implementation of eHealth interventions for patients with chronic illness and which ones are the most effective is unclear. OBJECTIVE: This systematic realist review aimed to summarize evidence from empirical studies regarding (1) which implementation strategies are used when implementing eHealth interventions for patients with chronic illnesses living at home, (2) implementation outcomes, and (3) the relationship between implementation strategies, implementation outcomes, and degree of implementation success. METHODS: A systematic literature search was performed in the electronic databases MEDLINE, Embase, PsycINFO, Scopus, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Library. Studies were included if they described implementation strategies used to support the integration of eHealth interventions into practice. Implementation strategies were categorized according to 9 categories defined by the Expert Recommendations for Implementing Change project: (1) engage consumers, (2) use evaluative and iterative strategies, (3) change infrastructure, (4) adapt and tailor to the context, (5) develop stakeholder interrelationships, (6) use financial strategies, (7) support clinicians, (8) provide interactive assistance, and (9) train and educate stakeholders. Implementation outcomes were extracted according to the implementation outcome framework by Proctor and colleagues: (1) acceptability, (2) adoption, (3) appropriateness, (4) cost, (5) feasibility, (6) fidelity, (7) penetration, and (8) sustainability. Implementation success was extracted according to the study authors' own evaluation of implementation success in relation to the used implementation strategies. RESULTS: The implementation strategies management support and engagement, internal and external facilitation, training, and audit and feedback were directly related to implementation success in several studies. No clear relationship was found between the number of implementation strategies used and implementation success. CONCLUSIONS: This is the first review examining implementation strategies, implementation outcomes, and implementation success of studies reporting the implementation of eHealth programs for patients with chronic illnesses living at home. The review indicates that internal and external facilitation, audit and feedback, management support, and training of clinicians are of importance for eHealth implementation. The review also points to the lack of eHealth studies that report implementation strategies in a comprehensive way and highlights the need to design robust studies focusing on implementation strategies in the future. TRIAL REGISTRATION: PROSPERO CRD42018085539; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=85539.