The effects of education based on the Roy adaptation model on medication adherence and psychosocial adjustment in hypertensive patients.

BACKGROUND AND AIM: Patient education utilizing nursing theory can enhance patient adherence to treatment and potentially decrease mortality rates. The objective of this investigation was to assess the impact of Roy's adaptation Model-focused education on medication adherence and psychosocial compliance in hypertensive patients. METHODS: This study was conducted in N = 60 hypertensive patients (n = 30 control group and n = 30 experimental group) based on a randomized controlled trial design. In the pre-test phase of the study, data was collected using the Patient Information Form, the medication adherence rating scale (MARS), and the psychosocial adjustment to illness scale-self-report (PAIS-SR). After the pre-test phase, the experimental group received hypertension education and the "Hypertension Education Booklet" for a duration of four weeks. No education was provided to the control group patients; only routine follow-ups were conducted. In the post-test phase (after four weeks), both groups were reassessed using MARS and PAIS-SR. After completing the study, the control group patients who volunteered to participate in the education were provided with hypertension education and the "Hypertension Education Booklet" for a duration of four weeks (n = 4). RESULTS: The post-test measurements of patients in the experimental group (after 4 weeks of education) revealed an increase in the mean MARS scores (6.50 ± 0.86) and a significant decrease in the total and subscale mean scores of PAIS-SR (24.12 ± 7.08) (p < 0.05). No changes were observed in the control group patients. CONCLUSION: The results of the study revealed that the education based on the Roy's Adaptation Model increased hypertensive individuals' medication adherence and physiological, psychological, and social adjustment to the disease. RELEVANCE TO CLINICAL PRACTICE: The education based on the Roy's Adaptation Model seems to be effective in increasing patients' adherence to treatment and adjustment to the disease. This model can be used in various diseases and societies, since it increases adjustment to the disease and the effectiveness of treatment.

Shifting Gears: Transitioning Healthy Lifestyle Education Into Early Post-Treatment Survivorship.

During cancer treatment, oncology nurses emphasize patient and family education about coping strategies to manage adverse events such as gastrointestinal effects and fatigue. However, information about how to return to health.

The Effects of WeChat-Based Teach-Back Health Education on Patients With Advanced Cancer Pain.

BACKGROUND: Providing effective health education is essential for patients with cancer-related pain. One solution is leveraging instant messaging tools for teach-back health education. OBJECTIVES: This study investigated the effects of WeChat-based teach-back health education on patients with advanced cancer who underwent patient-controlled intrathecal analgesia implantation and used hydromorphone. METHODS: This retrospective study evaluated 150 hospitalized patients with advanced cancer pain. Patients were classified into a conventional health education group (N = 50) and a teach-back group (N = 100) based on whether they received WeChat-based teach-back health education. Pain was rated using a numeric rating scale, and sleep quality was measured using the Pittsburgh Sleep Quality Index at one, two, and three months postdischarge. FINDINGS: Patients who received remote teach-back health education better managed their pain. Data also demonstrated improvements in patients' sleep quality and caregiver satisfaction, and reductions in the occurrence of adverse reactions.

Effectiveness of a pain neuroscience education programme on the physical activity of patients with chronic low back pain compared with a standard back school programme: protocol for a randomised controlled study (END-LC).

INTRODUCTION: Education is recognised as an effective and necessary approach in chronic low back pain. Nevertheless, data regarding the effectiveness of education in promoting physical activity in the medium term or long term are still limited, as are the factors that could lead to successful outcomes. Our study aims to assess the effectiveness of a pain neuroscience education programme compared with traditional back school on physical activity 3 months and 1 year after educational sessions coupled with a multidisciplinary rehabilitation programme. Additionally, we seek to evaluate the effects of these educational interventions on various factors, including pain intensity and psychobehavioural factors. Finally, our goal is to identify the determinants of success in educational sessions combined with the rehabilitation programme. METHODS AND ANALYSIS: The study will involve 82 adults with chronic low back pain. It will be a monocentric, open, controlled, randomised, superiority trial with two parallel arms: an experimental group, 'pain neuroscience education', and a control group, 'back school'. The primary outcome is the average number of steps taken at home over a week, measured by an actigraph. Secondary outcomes include behavioural assessments. Descriptive and inferential analysis will be conducted. Multivariate modelling will be performed using actimetric data and data from the primary and secondary outcomes. ETHICS AND DISSEMINATION: The Committee for Personal Protection of Ile de France VII (CPP) gave a favourable opinion on 22 June 2023 (National number: 2023-A00346-39). The study was previously registered with the National Agency for the Safety of Medicines and Health Products (IDRCB: 2023-A00346-39). Participants signed an informed consent during the inclusion visit. This protocol is the version submitted to the CPP entitled 'Protocol Version N°1 of 03/29/2023'. The results of the study will be presented nationally and internationally through conferences and publications. TRIAL REGISTRATION NUMBER: NCT05840302.

Effectiveness of in-group versus individually administered pain neuroscience education on clinical and psychosocial outcomes in patients with chronic low back pain: randomized controlled study protocol.

Objective: (1) This trial will compare the clinical and psychosocial effectiveness of in-group and individually pain neuroscience education (PNE) in patients with chronic low back pain (CLBP). In addition, (2) the influence of social determinants of health on post-treatment results will be analyzed. Methods: A three-arm randomized controlled trial will be conducted. Sixty-nine participants with CLBP will be recruited in a 1:1:1 ratio. Participants, assessor, and statistician will be blinded to group assignment. The PNE intervention will be adapted to the context of the participants. An experimental group (n = 33) will receive PNE in an in-group modality, the other experimental group (n = 33) will receive PNE in an individually modality and the control group (n = 33) will continue with usual care. Additionally, participants will be encouraged to stay active by walking for 20-30 min 3-5 times per week and will be taught an exercise to improve transversus abdominis activation (bracing or abdominal following). The outcome measures will be fear avoidance and beliefs, pressure pain threshold, pain self-efficacy, catastrophizing, pain intensity, and treatment expectation. Outcome measures will be collected at one-week before intervention, immediately post-intervention, and four-weeks post-intervention. Conclusion: The innovative approach of PNE oriented to fear beliefs proposed in this study could broaden the application strategies of this educational therapeutic modality. Impact. Contextualized PNE delivered by physical therapist could be essential to achieve a good cost-effectiveness ratio of this intervention to improve the clinical condition of people with CLBP.

Evaluating the web as a source of information for patients with chest wall deformities: insights into engagement and disparities.

BACKGROUND: Recent data highlight the internet's pivotal role as the primary information source for patients. In this study, we emulate a patient's/caregiver's quest for online information concerning chest deformities and assess the quality of available information. METHODS: We conducted an internet search using combination of the terms "pectus excavatum," "pectus excavatum surgery," "funnel chest," "pectus excavatum repair" and identified the first 100 relevant websites from the three most popular search engines: Google, Yahoo, and Bing. These websites were evaluated using the modified Ensuring Quality Information for Patients (EQIP) instrument. RESULTS: Of the 300 websites generated, 140 (46.7%) were included in our evaluation after elimination of duplicates, non-English websites, and those targeting medical professionals. The EQIP scores in the final sample ranged from 8 to 32/36, with a median score of 22. Most of the evaluated websites (32.8%) originated from hospitals, yet none met all 36 EQIP criteria. DISCUSSION: None of the evaluated websites pertaining to pectus excavatum achieved a flawless "content quality" score. The diverse array of websites potentially complicates patients' efforts to navigate toward high-quality resources. Barriers in accessing high-quality online patient information may contribute to disparities in referral, patient engagement, treatment satisfaction, and overall quality of life. LEVEL OF EVIDENCE: IV.

Improving foot self-care in people with diabetes in Ghana: A development and feasibility randomised trial of a context appropriate, family-orientated diabetic footcare intervention.

OBJECTIVE: Africa presents a higher diabetic foot ulcer prevalence estimate of 7.2% against global figures of 6.3%. Engaging family members in self-care education interventions has been shown to be effective at preventing diabetes-related foot ulcers. This study culturally adapted and tested the feasibility and acceptability of an evidence-based footcare family intervention in Ghana. METHODS: The initial phase of the study involved stakeholder engagement, comprising Patient Public Involvement activities and interviews with key informant nurses and people with diabetes (N = 15). In the second phase, adults at risk of diabetes-related foot ulcers and nominated caregivers (N = 50 dyads) participated in an individually randomised feasibility trial of the adapted intervention (N = 25) compared to usual care (N = 25). The study aimed to assess feasibility outcomes and to identify efficacy signals on clinical outcomes at 12 weeks post randomisation. Patient reported outcomes were foot care behaviour, foot self-care efficacy, diabetes knowledge and caregiver diabetes distress. RESULTS: Adjustments were made to the evidence-based intervention to reflect the literacy, information needs and preferences of stakeholders and to develop a context appropriate diabetic foot self-care intervention. A feasibility trial was then conducted which met all recruitment, retention, data quality and randomisation progression criteria. At 12 weeks post randomisation, efficacy signals favoured the intervention group on improved footcare behaviour, foot self-care efficacy, diabetes knowledge and reduced diabetes distress. Future implementation issues to consider include the staff resources needed to deliver the intervention, family members availability to attend in-person sessions and consideration of remote intervention delivery. CONCLUSION: A contextual family-oriented foot self-care education intervention is feasible, acceptable, and may improve knowledge and self-care with the potential to decrease diabetes-related complications. The education intervention is a strategic approach to improving diabetes care and prevention of foot disease, especially in settings with limited diabetes care resources. Future research will investigate the possibility of remote delivery to better meet patient and staff needs. TRIAL REGISTRATION: Pan African Clinical Trials Registry (PACTR) - PACTR202201708421484: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 or pactr.samrc.ac.za/Search.aspx.

MASCC 2023 Patient-Centered Antiemetic Guidelines and Education Statements: an evidence-based and consensus resource for patients.

PURPOSE: The Multinational Association of Supportive Care in Cancer (MASCC)/European Society of Medical Oncology (ESMO) Patient Antiemetic Guideline Committee aimed to (1) adapt the updated evidence-based, clinical guidelines to patient-centered antiemetic guidelines and (2) develop patient education materials and statements. METHODS: The MASCC 2023 Patient Antiemetic Guidelines were created and reviewed by antiemetic experts and patient advocates by incorporating the 2023 MASCC/ESMO antiemetic guidelines into patient-friendly language. Patient Education Statements were developed based on current literature and by utilizing an expert modified Delphi consensus (≥ 75% agreement). Patient advocate/focus group input and patient survey results were further integrated into Patient-Centered Antiemetic Guidelines and Education Statements. RESULTS: Patient-Centered Antiemetic Guidelines were created using patient-friendly language and visual slides. Patient-friendly language was also utilized to communicate the Educational Statements. Key content categories identified for the Educational Statements included the following: nausea/vomiting definitions, causes, risk factors, categories, complications, accompanying symptoms, prophylactic antiemetic treatment, general management, when to call/what to ask the healthcare team, what caregivers can do, and available resources. All identified content met the ≥ 75% expert agreement threshold. Fifteen (15) items demonstrated 100% agreement, 11 items achieved ≥ 90% agreement, and three content items demonstrated 80 ~ 82% agreement. CONCLUSIONS: The inaugural MASCC 2023 Patient Antiemetic Guidelines can help patients and caregivers understand the prevention of nausea and vomiting related to their cancer treatment. Educational Statements provide further patient information. Educating patients on how to utilize guideline antiemetics and the education statements can contribute improvements in the control of anticancer treatment-related nausea and vomiting.

The effect of educational intervention on the quality of life of women suffering from pregnancy-related nausea and vomiting: a systematic review.

OBJECTIVE: The present study aimed to determine the influence of educational interventions on improving the quality of life (QOL) of women suffering from pregnancy-related nausea and vomiting (NVP) as a systematic review. METHODS: The current systematic review followed the standard Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist guideline. The English electronic databases were used to identify relevant studies published 2000 until 14 August 2023. The search strategies employed were based on Mesh browser keywords and free-text words. The study risk of bias was evaluated using the Cochrane Collaboration's tool for assessing the risk of bias tools and publication bias was evaluated using a funnel plot and Begg and Egger tests. The heterogeneity of the studies was evaluated using I2 and tau-squared tests. Data were analyzed using the RevMan 5 software. Results of the random-effects meta-analysis were presented using the standard mean difference, along with a 95% confidence interval (CI). RESULTS: Out of the seven randomized clinical/control trial (RCT) studies with a total of 946 subjects included in the review, five studies reported a significant result, indicating that the interventions had a statistically significant effect on the QOL of women suffering NVP and in two studies did not have a significant result. A subgroup analysis was done based on the type of quality-of-life measurements. The pooled standardized mean difference (SMD) of four articles (Nausea and Vomiting Pregnancy Quality of Life, NVPQOL) with a total of 335 subjects was -2.91, and CI of -4.72 to -1.11, p value = .002, I2 = 97.2%. The pooled SMD of three articles (SF36) with a total of 611 subjects was -0.05, and CI of -0.23 to -0.12, p value = .550, I2 = 10%. CONCLUSIONS: The overall results of the analysis indicated that educational intervention had a small positive impact on the QOL of women experiencing NVP. However, to draw a better conclusion, it is recommended to conduct further studies with larger sample sizes and longer follow-up periods.

Skin Tone Representation on Patient-Facing Skin Cancer Education Websites.

When patients self-detect suspicious skin lesions, they often reference online photos prior to seeking medical evaluation. Online images must be available in the full spectrum of skin tones to provide accurate visualizations of disease, especially given the increased morbidity and mortality from skin cancer in patients with darker skin tones. The purpose of this study was to evaluate the representation of skin tones in photos of skin cancer on patient-facing websites. Six federally-based and organization websites were evaluated, and of the 372 total representations identified only 49 depicted darker skin tones (13.2%). This highlights the need to improve skin tone representation on patient-facing online resources. J Drugs Dermatol. 2024;23(5):e137-e138.     doi:10.36849/JDD.7905e.

Report from a text-based blood pressure monitoring prospective cohort trial among postpartum women with hypertensive disorders of pregnancy.

BACKGROUND: Hypertensive disorders of pregnancy are a main cause of maternal morbidity and mortality in the United States and worldwide, and it is estimated that approximately 60% of maternal deaths in the United States occur during the postpartum period. The utilization of telehealth modalities such as home blood pressure monitoring has shown improvement in blood pressure control and adherence with follow up visits. Our study sought to determine if standardized education improved patient hypertension knowledge and if this when combined with home blood pressure telemonitoring increased participants' postpartum self-blood pressure monitoring and postpartum visit attendance. METHODS: This is an Institutional Review Board approved prospective cohort study conducted at the University of Mississippi Medical Center. Women with a hypertensive disorder of pregnancy who met the inclusion criteria and provided written informed consent to participate were enrolled. Participants received a baseline pre-education questionnaire designed to assess their knowledge of their hypertensive diagnosis, hypertension management, and postpartum preeclampsia (PreE). Participants then received standard education, a blood pressure monitor, and were scheduled a follow-up visit during the first 10 days following discharge. Remote home blood pressure monitoring was performed via text messages and voice calls for 6-weeks postpartum. At the conclusion of the study, participants repeated their original questionnaire. RESULTS: 250 women provided informed consent to participate in the study and were included in this analysis. Relative to the baseline survey, there was a significant increase (p = 0.0001) in the percentage of correct responses. There was not an association between study engagement and percentage of correct responses on end of study questionnaire (p = 0.33) or postpartum visit attendance (p = 0.69). Maternal age was found to drive study engagement, even when adjusted for community-level distress (p = 0.03) and maternal race (p = 0.0002). CONCLUSION: Implementing a standardized postpartum education session was associated with improvement in patient's knowledge. Further studies are needed with more longitudinal follow up to assess if this program would also result in improved long-term outcomes and decreased hospital readmission rates. TRIAL REGISTRATION: NCT04570124.

Safe Fall Recovery Education for Older Adults.

High fall rates among older adults in combination with prolonged time on the floor after a fall have created an urgent need to preventatively address fall recovery strategies. The purpose of this study is to describe the outcomes of a novel safe fall recovery (SFR) educational module provided by physical therapists to older adults in their homes. A pre- and post-test descriptive study used a convenience sample to recruit 30 adults (≥65 years). A baseline assessment and SFR in-home education were provided. Pre- and post-education measures included the Steps for Safe Fall Recovery (Steps for SFR) tool, the Activity Specific Balance Confidence (ABC) scale, and a fall confidence survey. The Wilcoxon matched-pairs signed-rank test determined significance (P < .05). Participants were age 77.2 (6.8) years and 20 females. Eight reported a fall during the prior year. Statistically significant improvements were identified in the Steps to SFR tool (P = .001), the ABC scale (P = .004), and the fall recovery confidence survey (P = .001). Integration of an SFR educational intervention delivered to an older adult population in their home demonstrated improved safety and confidence to recover from a fall.

Language-adaptive artificial intelligence: assessing CHATGPT'S answer to frequently asked questions on total hip arthroplasty questions.

ChatGPT is reported to be an acceptable tool to answer a majority of frequently asked patient questions. ChatGPT also converses in other languages including Urdu, which offers immense potential for the education of Pakistani patients. Therefore, this study evaluated ChatGPT's Urdu answers to the ten most frequently asked questions on Total Hip Arthroplasty, which were then rated by an expert. Out of 10 answers in English, 9 (90%) were satisfactory requiring minimal clarification and 1 (10%) was satisfactory requiring moderate clarification. In both Roman and Nastaliq script Urdu, 1 (10%) answer was satisfactory requiring moderate clarification, while 9 (90%) were unsatisfactory requiring substantial clarification. In conclusion, as opposed to ChatGPT English responses, Urdu responses were much less rigorous, generic, and lacked scientific rigor. We have a long way to go before Pakistani patients with limited English language skills could benefit from AI chatbots like ChatGPT.

Effect of diabetes self-management education on health-related quality of life of Tunisian children with type1 diabetes mellitus and their parents: A randomized controlled trial.

AIM: To assess the effect of diabetes self-management education (DSME) on health related quality of life (HRQoL) of Tunisian children/adolescents with type 1 diabetes mellitus and their parents. METHODS: This monocentral study used a randomized controlled trial design, during five-month intervention and five-month follow-up and including 110 patients (54 in the DSME intervention group and 56 in the Individual Education by Pediatrician (IEP) control group) and their parents. Pediatric Generic Core Quality-of-Life Inventory 4.0-Scale (PedsQL4.0) evaluated HRQoL. RESULTS: At baseline, both groups had similar clinical features and PedsQL4.0 scores (p>0.05). In DSME, clinical outcomes were significantly improved from baseline to follow-up (p<0.001), while in the IEP group, which received no intervention, these outcomes remained unchanged. During follow-up, DSME showed higher PedsQL4.0 scores in parents' proxy-report and children/adolescents self-report (p<0.001). According to parents' proxy-report, PedsQL4.0 scores were significantly higher during follow-up compared to baseline in DSME (p<0.001) while they remained the same in IEP (p>0.05). DSME had higher percentage of change in the PedsQL4.0 scores than IEP (p<0.01). The median change varied from -5.01% to 0% vs 5.41% to 36.36% in IEP and DSME, respectively. CONCLUSION: Encouraging healthcare professionals to incorporate these interventions could enhance the HRQoL of diabetic children and bolster their self-esteem.

Study protocol of a prospective, interventional non-randomised trial investigating the impact of asthma education on specific disease understanding, health literacy and therapy outcome in childhood.

INTRODUCTION: Childhood asthma is a highly prevalent chronic disease. A failure to implement patient education programmes may result in increased morbidity, despite the availability of distinct diagnostic and therapeutic approaches. Patients with lower socioeconomic status (SES) tend to have a higher asthma prevalence. Moreover, the progression of asthma is significantly influenced by factors such as health literacy and the children's specific knowledge about the condition. With this trial, the primary objective is to evaluate whether asthma education enhances specific disease understanding in children with asthma (primary outcome). Secondary objectives include evaluating training effects on health literacy, retention rates of information, 'Children Asthma Control Test' (C-ACT) score, frequency of emergency room and physician visits (secondary outcomes) and whether SES influences training effects. METHODS AND ANALYSIS: To address the research objectives, this study comprises two projects. The first subproject will investigate the influence of asthma training on the development of disease understanding and health literacy. The second subproject will analyse the influence of SES on the outcome of children participating in asthma training. This research is designed as a comparative, non-randomised study involving two paediatric groups between the ages of ≥7 and < 14 years. After being diagnosed with asthma, the intervention group undergoes standardised psychoeducational asthma training at a certified centre associated with paediatricians in private practice in Germany, following the recommendations of the 'Arbeitsgruppe Asthmaschulung im Kindes- und Jugendalter e.V.', a national association aiming to establish uniform and guideline-based standards for patient education in children and adolescents. The comparison group receives a significantly shorter period of education and instruction on the usage of asthma medication at outpatient clinics. Data will be collected from patients and their parents at three specific survey time points, based on standardised tools.To describe mean differences between the intervention and control group over time (subproject 1), a repeated-measures analysis of variance (ANOVA) will be conducted. In subproject 2, multivariate linear regression analysis will be used to analyse the variables determining the changes in specific disease understanding and health literacy, including SES. The sample size calculation is based on a mixed ANOVA model with two groups and two measurements resulting in a total of 126 participants. ETHICS AND DISSEMINATION: All protocols and a positive ethics approval were obtained from the Witten/Herdecke University, Germany (S-159, 2023; application submission: 24 June 2023, final vote: 10 July 2023). Furthermore, the study was registered at the German Clinical Trials Register (DRKS), DRKS00032423. The application submission was on 3 August 2023, and the final approval was on 4 August 2023. The results will be disseminated among experts and participants and will be published in peer-reviewed, international journal with open access. TRIAL REGISTRATION NUMBER: DRKS00032423.

Impact of Patient Education Formats on Treatment Adherence and Denture Hygiene in Edentulous Patients: A Comparative Study.

BACKGROUND Effective communication and patient education are important in geriatric dental care. Memory decline complicates patient adherence. This study aimed to compare verbal, audio, and video patient education material (PEM) and adherence to dental prosthetic management in edentulous patients. MATERIAL AND METHODS 90 completely/partially edentulous patients (aged 40 to 70 years), were divided (simple random) into three groups (Gp) of 30 each . A total of 68 instructions were organized into 9 learning categories. For GpVi, a 20 minute video was shot using a Sony camera (PD170), with two actors depicting related PEM information. Patients were recalled after 1 day and 7days, to recall the PEM instructions. A Denture plaque Index (DPI) determined the efficiency of the instructions at both time intervals. Frequencies, means and standard deviations were derived for each group and then compared using Chi square, paired and unpaired t test and a Neuman-Keul post hoc pairwise test. All significant differences were kept at probability t value of ≤0.05. RESULTS PEM instructions related to patient individuality, proper tongue position and miscellaneous showed poor patient recall. At 1 day interval, audio was found to have better recall than video and verbal in 5 PEM instruction categories. At 7 day interval, video showed better recall than other two groups (P≤0.05). Despite improvements in patients recall, DPI revealed better denture hygiene maintenance in patients receiving instructions through video format (P≤0.05). CONCLUSIONS For all categories, no single media was considered to be sufficient, audio produced early better recall while video influenced long term recall and better denture hygiene maintenance.

Creating Behavior Change for Interdental Biofi lm Disruption: Oral Irrigation as a Solution to Increasing Patient Compliance.

Interdental cleaning is critical to maintaining oral health, preventing dental issues, and promoting overall well-being. However, many patients either struggle with consistently following recommended interdental care routines or have poor technique when complying with recommendations. Addressing this problem requires a multifaceted approach comprised of tailored patient education and patient-clinician partnership to provide both an effective interdental cleaning tool and an accessible method for the patient to implement the modified interdental habit into their routine. The aim of this article is to discuss the different modalities for interdental cleaning, how to assess patient candidacy for different interdental cleaning modalities, and behavior-change strategies to promote patient compliance to recommended interdental care.

Designing multimedia patient education materials for adolescent idiopathic scoliosis: A protocol for a feasibility randomized controlled trial of patient education videos.

Triple-masked three-armed feasibility parallel randomized controlled trial. Multimedia patient education materials are increasingly used in healthcare. While much research focuses on optimising their scientific content, research is equally needed to optimise design and implementation. This study aims to determine the feasibility of a study examining how the implementation of scientific advice on design affects patient outcomes. Participants aged 10-18 with radiographically confirmed adolescent idiopathic scoliosis will be recruited from community settings in Ireland and randomized into usual care or receiving multimedia educational videos with or without evidence-informed design principles. Participants will be masked in the two video intervention arms, as will the therapist sending the educational videos. Outcomes will include the number of participants recruited and randomized, the number analysed post-intervention and at week eight, and the outcomes for baseline, post-intervention, and week 8. Adverse events will also be reported. This feasibility randomized controlled trial will offer insight into the feasibility of implementing advice from the literature in designing a trial of multimedia patient education materials for a population with adolescent idiopathic scoliosis. Trial registration: Clinical Trail: Trial is registered on ClinicalTrials.gov as NCT06090344.

Study protocol: group-based psychoeducation for relatives of patients with bipolar disorder-a large scale real-world randomized controlled parallel group trial, the R-bipolar RCT.

BACKGROUND: Relatives of patients with bipolar disorder (BD) often experience emotional burden with stress and depressive symptoms that again increase the likelihood of destabilization and relapses in the patient. The effects of group-based psychoeducation have not been investigated in large-scale real-world settings. We are currently conducting a large-scale real-world randomized controlled parallel group trial (RCT) to test whether group-based psychoeducation for 200 relatives to patients with BD improves mood instability and other critical outcomes in relatives and the corresponding patients with BD. METHODS: The trial is designed as a two-arm, parallel-group randomized trial with a balanced randomization 1:1 to either group-based psychoeducation or a waiting list for approximately 4 months and subsequent group-based psychoeducation. The primary outcome measure is mood instability calculated based on daily smartphone-based mood self-assessments. Other relevant outcomes are measured, including patients' reported outcomes, assessing self-assessed burden, self-efficacy, and knowledge about BD. DISCUSSION: This protocol describes our currently ongoing randomized controlled trial (RCT) that aims at investigating group-based psychoeducation as an intervention for relatives of individuals diagnosed with bipolar disorder (BD). The study is the first large-scale real-world RCT to focus on a relatively short intervention of psychoeducation (6 sessions of 2 h each) in a large group of relatives (approximately 30 participants per group). With this focus, we wish to test an intervention that is feasible to implement in real-life psychiatric settings with limited budgets and time. It is also the first study to use mood instability in relatives as the primary outcome measure and to investigate whether mood instability and other affective symptoms in patients and relatives covary. It could be considered as limitations, that the trial is not blinded and does not include long-term follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT06176001. Registered on 2023-12-19. The study is approved by the data agency (P-2021-809). The project was allowed to be initiated without permission from the Scientific Ethical Committees for the Capital Region, because it according to section 1, paragraph 4 of the Committee Act was not defined as a health scientific intervention study (case number 21063013).