The Journeying through Dementia psychosocial intervention versus usual care study: a single-blind, parallel group, phase 3 trial.

BACKGROUND: There is an urgent clinical need for evidence-based psychosocial interventions for people with mild dementia. We aimed to determine the clinical benefits and cost-effectiveness of Journeying through Dementia (JtD), an intervention designed to promote wellbeing and independence in people with mild dementia. METHODS: We did a single-blind, parallel group, individually randomised, phase 3 trial at 13 National Health Service sites across England. People with mild dementia (Mini-Mental State Examination score of ≥18) who lived in the community were eligible for inclusion. Patients were centrally randomly assigned (1:1) to receive the JtD intervention plus standard care (JtD group) or standard care only (standard care group). Randomisation was stratified by study site. The JtD intervention included 12 group and four one-to-one sessions, delivered in the community at each site. The primary endpoint was Dementia Related Quality of Life (DEMQOL) 8 months after randomisation, assessed according to the intention-to-treat principle. Only outcome assessors were masked to group assignment. A cost-effectiveness analysis reported cost per quality-adjusted life-year (QALY) from a UK NHS and social care perspective. The study is registered with ISRCTN, ISRCTN17993825. FINDINGS: Between Nov 30, 2016, and Aug 31, 2018, 1183 patients were screened for inclusion, of whom 480 (41%) participants were randomly assigned: 241 (50%) to the JtD group and 239 (50%) to the standard care group. Intervention adherence was very good: 165 (68%) of 241 participants in the JtD group attended at least ten of the 16 sessions. Mean DEMQOL scores at 8 months were 93·3 (SD 13·0) for the JtD group and 91·9 (SD 14·6) for the control group. Difference in means was 0·9 (95% CI -1·2 to 3·0; p=0·38) after adjustment for covariates, lower than that identified as clinically meaningful. Incremental cost per QALY ranged from £88 000 to -£205 000, suggesting that JtD was not cost-effective. Unrelated serious adverse events were reported by 40 (17%) patients in the JtD group and 35 (15%) patients in the standard care group. INTERPRETATION: In common with other studies, the JtD intervention was not proven effective. However, this complex trial successfully recruited and retained people with dementia without necessarily involving carers. Additionally, people with dementia were actively involved as participants and study advisers throughout. More research into methods of measuring small, meaningful changes in this population is needed. Questions remain regarding how services can match the complex, diverse, and individual needs of people with mild dementia, and how interventions to meet such needs can be delivered at scale. FUNDING: UK National Institute of Health Research Health Technology Assessment Programme.

Estimating the minimum important difference in the DEMQOL instrument in people with dementia.

PURPOSE: The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients' lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. METHODS: Anchor-based and distribution-based methods were used to estimate the MID scores from patients enrolled in a randomised controlled trial. For the anchor-based method, the global QOL (Q29) item from the DEMQOL was chosen as the anchor for DEMQOL and both Q29 and EQ-5D for DEMQOL-U. A one category difference in Q29, and a 0.07 point difference in EQ-5D score, were used to classify improvement and deterioration, and the MID scores were calculated for each category. These results were compared with scores obtained by the distribution-based methods. RESULTS: A total of 490 people with dementia had baseline DEMQOL data, of these 386 had 8-month data, and 344 had 12-month DEMQOL data. The absolute change in DEMQOL for a combined 1-point increase or decrease in the Q29 anchor was 5.2 at 8 months and 6.0 at 12 months. For the DEMQOL-U, the average absolute change at 8 and 12 months was 0.032 and 0.046 for the Q29 anchor and 0.020 and 0.024 for EQ-5D anchor. CONCLUSION: We present MID scores for the DEMQOL and DEMQOL-U instruments obtained from a large cohort of patients with dementia. An anchored-based estimate of the MID for the DEMQOL is around 5 to 6 points; and 0.02 to 0.05 points for the DEMQOL-U. The results of this study can guide clinicians and researchers in the interpretation of these instruments comparisons between groups or within groups of people with dementia. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ISRCTN17993825 on 11th October 2016.

Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project.

OBJECTIVE: To provide guidance to researchers, funders, regulators and study delivery teams to ensure that research on COVID-19 is inclusive, particularly of groups disproportionately affected by COVID-19 and who may have been historically under-served by research. SUMMARY OF KEY POINTS: Groups who are disproportionately affected by COVID-19 include (but are not limited to) older people, people with multiple long-term conditions, people with disabilities, people from Black, Asian and Ethnic minority groups, people living with obesity, people who are socioeconomically deprived and people living in care homes. All these groups are under-served by clinical research, and there is an urgent need to rectify this if COVID-19 research is to deliver relevant evidence for these groups who are most in need. We provide a framework and checklists for addressing key issues when designing and delivering inclusive COVID-19 research, based on the National Institute for Health Research INnovations in CLinical trial design and delivery for the UnDEr-served project roadmap. Strong community engagement, codevelopment and prioritisation of research questions and interventions are essential. Under-served groups should be represented on funding panels and ethics committees, who should insist on the removal of barriers to participation. Exclusion criteria should be kept to a minimum; intervention delivery and outcome measurement should be simple, flexible and tailored to the needs of different groups, and local advice on the best way to reach and engage with under-served communities should be taken by study delivery teams. Data on characteristics that allow identification of under-served groups must be collected, analyses should include these data to enable subgroup comparisons and results should be shared with under-served groups at an early stage. CONCLUSION: Inclusive COVID-19 research is a necessity, not a luxury, if research is to benefit all the communities it seeks to serve. It requires close engagement with under-served groups and attention to aspects of study topic, design, delivery, analysis and dissemination across the research life cycle.

Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process.

BACKGROUND: Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. Enhancing representation of under-served groups in clinical research is important to ensure that research findings are widely applicable. We describe a multicomponent workstream project to improve representation of under-served groups in clinical trials. METHODS: The project comprised three main strands: (1) a targeted scoping review of literature to identify previous work characterising under-served groups and barriers to inclusion, (2) surveys of professional stakeholders and participant representative groups involved in research delivery to refine these initial findings and identify examples of innovation and good practice and (3) a series of workshops bringing together key stakeholders from funding, design, delivery and participant groups to reach consensus on definitions, barriers and a strategic roadmap for future work. The work was commissioned by the UK National Institute for Health Research Clinical Research Network. Output from these strands was integrated by a steering committee to generate a series of goals, workstream plans and a strategic roadmap for future development work in this area. RESULTS: 'Under-served groups' was identified and agreed by the stakeholder group as the preferred term. Three-quarters of stakeholders felt that a clear definition of under-served groups did not currently exist; definition was challenging and context-specific, but exemplar groups (e.g. those with language barriers or mental illness) were identified as under-served. Barriers to successful inclusion of under-served groups could be clustered into communication between research teams and participant groups; how trials are designed and delivered, differing agendas of research teams and participant groups; and lack of trust in the research process. Four key goals for future work were identified: building long-term relationships with under-served groups, developing training resources to improve design and delivery of trials for under-served groups, developing infrastructure and systems to support this work and working with funders, regulators and other stakeholders to remove barriers to inclusion. CONCLUSIONS: The work of the INCLUDE group over the next 12 months will build on these findings by generating resources customised for different under-served groups to improve the representativeness of trial populations.

The Use of a Smartphone App and an Activity Tracker to Promote Physical Activity in the Management of Chronic Obstructive Pulmonary Disease: Randomized Controlled Feasibility Study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is highly prevalent and significantly affects the daily functioning of patients. Self-management strategies, including increasing physical activity, can help people with COPD have better health and a better quality of life. Digital mobile health (mHealth) techniques have the potential to aid the delivery of self-management interventions for COPD. We developed an mHealth intervention (Self-Management supported by Assistive, Rehabilitative, and Telehealth technologies-COPD [SMART-COPD]), delivered via a smartphone app and an activity tracker, to help people with COPD maintain (or increase) physical activity after undertaking pulmonary rehabilitation (PR). OBJECTIVE: This study aimed to determine the feasibility and acceptability of using the SMART-COPD intervention for the self-management of physical activity and to explore the feasibility of conducting a future randomized controlled trial (RCT) to investigate its effectiveness. METHODS: We conducted a randomized feasibility study. A total of 30 participants with COPD were randomly allocated to receive the SMART-COPD intervention (n=19) or control (n=11). Participants used SMART-COPD throughout PR and for 8 weeks afterward (ie, maintenance) to set physical activity goals and monitor their progress. Questionnaire-based and physical activity-based outcome measures were taken at baseline, the end of PR, and the end of maintenance. Participants, and health care professionals involved in PR delivery, were interviewed about their experiences with the technology. RESULTS: Overall, 47% (14/30) of participants withdrew from the study. Difficulty in using the technology was a common reason for withdrawal. Participants who completed the study had better baseline health and more prior experience with digital technology, compared with participants who withdrew. Participants who completed the study were generally positive about the technology and found it easy to use. Some participants felt their health had benefitted from using the technology and that it assisted them in achieving physical activity goals. Activity tracking and self-reporting were both found to be problematic as outcome measures of physical activity for this study. There was dissatisfaction among some control group members regarding their allocation. CONCLUSIONS: mHealth shows promise in helping people with COPD self-manage their physical activity levels. mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD. Simplicity and usability were more important for engagement with the SMART-COPD intervention than personalization; therefore, the intervention should be simplified for future use. Future evaluation will require consideration of individual factors and their effect on mHealth efficacy and use; within-subject comparison of step count values; and an opportunity for control group participants to use the intervention if an RCT were to be carried out. Sample size calculations for a future evaluation would need to consider the high dropout rates.

Qualitatively exploring the suitability of tablet computers to encourage participation with activities by people with moderate stage dementia.

INTRODUCTION: Opportunities to participate with enjoyable activities is one of the most frequently reported unmet needs by the person living with dementia. Enabling and intuitive technologies may offer accessible ways to engage with such activities. OBJECTIVES: To explore how tablet computers might encourage participation in enjoyable activities by people with moderate levels of dementia and to consider how such technologies might be incorporated into the repertoire of activities currently provided through day care settings. METHODS: A focused visual ethnographic approach was developed specifically to meet the research objectives. Twelve participants attending a community day care centre and nine supporters (both volunteers and paid staff) consented to take part in the research. Technology facilitated group activity sessions took place twice a week for a period of four weeks and all were video recorded. Findings: Video analysis demonstrated that the majority of people with dementia found the technology an effective means of participating in enjoyable activities. Analysis also revealed the extent to which participation relies on the existence of effective support. It showed how maintaining focus on retained strengths and abilities enabled the group overall to meet and often exceed their own and others perceived capacity to participate. Finally, analysis confirmed the importance of enjoyment of activities 'in the moment' and the need for those supporting people in the moderate stages of dementia to acknowledge and work with this. CONCLUSION: The use of tablet computers to enhance participation in sociable and enjoyable activities in day care settings is realistic and achievable if supported appropriately.

Does Telehealth Monitoring Identify Exacerbations of Chronic Obstructive Pulmonary Disease and Reduce Hospitalisations? An Analysis of System Data.

BACKGROUND: The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease (COPD) is unsustainable. Health care organizations are focusing on ways to support self-management and prevent hospital admissions, including telehealth-monitoring services capturing physiological and health status data. This paper reports on data captured during a pilot randomized controlled trial of telehealth-supported care within a community-based service for patients discharged from hospital following an exacerbation of their COPD. OBJECTIVE: The aim was to undertake the first analysis of system data to determine whether telehealth monitoring can identify an exacerbation of COPD, providing clinicians with an opportunity to intervene with timely treatment and prevent hospital readmission. METHODS: A total of 23 participants received a telehealth-supported intervention. This paper reports on the analysis of data from a telehealth monitoring system that captured data from two sources: (1) data uploaded both manually and using Bluetooth peripheral devices by the 23 participants and (2) clinical records entered as nursing notes by the clinicians. Rules embedded in the telehealth monitoring system triggered system alerts to be reviewed by remote clinicians who determined whether clinical intervention was required. We also analyzed data on the frequency and length (bed days) of hospital admissions, frequency of hospital Accident and Emergency visits that did not lead to hospital admission, and frequency and type of community health care service contacts-other than the COPD discharge service-for all participants for the duration of the intervention and 6 months postintervention. RESULTS: Patients generated 512 alerts, 451 of which occurred during the first 42 days that all participants used the equipment. Patients generated fewer alerts over time with typically seven alerts per day within the first 10 days and four alerts per day thereafter. They also had three times more days without alerts than with alerts. Alerts were most commonly triggered by reports of being more tired, having difficulty with self-care, and blood pressure being out of range. During the 8-week intervention, and for 6-month follow-up, eight of the 23 patients were hospitalized. Hospital readmission rates (2/23, 9%) in the first 28 days of service were lower than the 20% UK norm. CONCLUSIONS: It seems that the clinical team can identify exacerbations based on both an increase in alerts and the types of system-generated alerts as evidenced by their efforts to provided treatment interventions. There was some indication that telehealth monitoring potentially delayed hospitalizations until after patients had been discharged from the service. We suggest that telehealth-supported care can fulfill an important role in enabling patients with COPD to better manage their condition and remain out of hospital, but adequate resourcing and timely response to alerts is a critical factor in supporting patients to remain at home. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 68856013; http://www.isrctn.com/ISRCTN68856013 (Archived by WebCite at http://www.webcitation.org/6ofApNB2e).

Comparison of patient perceptions of Telehealth-supported and specialist nursing interventions for early stage COPD: a qualitative study.

BACKGROUND: The increasing prevalence and associated cost of treating Chronic Obstructive Pulmonary Disease (COPD) is unsustainable, and focus is needed on self-management and prevention of hospital admissions. Telehealth monitoring of patients' vital signs allows clinicians to prioritise their workload and enables patients to take more responsibility for their health. This paper reports the results of a qualitative study embedded within a feasibility and pilot Randomised Controlled Trial (RCT) of Telehealth-supported care within a community-based COPD supported-discharge service. The aim of the study was to qualitatively explore the experiences of patients with COPD who had received either a Telehealth-supported or a specialist nursing intervention following their discharge from hospital after an admission for a COPD exacerbation. METHODS: Patients were invited to either participate in semi-structured interviews or to complete a semi-structured self-administered questionnaire on completion of the intervention. Nine patients were interviewed (67 % female) and seventeen patients completed the questionnaires. In addition, three clinicians responsible for the delivery of both interventions were interviewed to obtain their perspectives on the new services. RESULTS: Seven underlying themes emerged from the patient interviews and were further explored in the questionnaires: (1) patient demographics; (2) information received by the participants; (3) installation of the Telehealth technology; (4) Telehealth service functionality; (5) visits; (6) service withdrawal; and (7) service perceptions. Recipients of both services reported feelings of safety derived from the delivery of an integrated, community-based service. CONCLUSIONS: Although recipients of the Telehealth service received 50 % fewer home visits from the clinicians than recipients of a more traditional community-based nursing intervention, the patients were enthusiastic about the service, with some describing it as the best service they had ever received. This suggests that a Telehealth intervention is an acceptable alternative to a more traditional home nursing visit model for monitoring community-based patients with COPD following their discharge from hospital. TRIAL REGISTRATION: Current Controlled Trials ISRCTN68856013.

Environmental Restrictors to Occupational Participation in Old Age: Exploring Differences across Gender in Puerto Rico.

Many older adults face challenges that prevent them from accomplishing common daily activities such as moving around, home maintenance, and leisure activities. There is still a need to examine and understand how environmental factors impact daily participation across gender. This study sought to make a qualitative comparison of gender differences regarding environmental barriers to participation in daily occupations from the perspectives of older adults who live alone in Puerto Rico. Twenty-six Hispanic older adults, 70 years or older participated in this study. We used a descriptive qualitative research design in which researchers administered an in-depth interview to each participant. The results elucidated that women were more likely than men to experience restricted participation due to lack of accessibility of the built environment and transportation systems. The findings could help with the development of tailored, occupation-based, preventive interventions that address gender specific environmental barriers and promote greater participation among both women and men. Further research is required to explore whether these environmental barriers to occupational participation remain consistent across living situations, socioeconomic status and ethnicity.

Journeying through Dementia, a community-based self-management intervention for people aged 65 years and over: a feasibility study to inform a future trial.

BACKGROUND: A study to determine the feasibility of conducting a future population-based trial into a self-management intervention for community-living adults with early stage dementia included evaluation of intervention content and modes of delivery, staffing requirements, recruitment methods and the utility and usability of patient reported outcomes. METHODS: Participants identified through memory clinics in one city took part in an intervention called 'Journeying through Dementia'. The 12-week programme incorporating four individual sessions with one of the facilitators encourages participants to engage in discussion and activities related to health and well-being positioning them as the expert enabling long-term behavioural change. Participants (n = 10) and their nominated carers (n = 7) were all asked to complete selected outcomes at baseline, 8 weeks (participants only) and post intervention and invited to comment on their usability. All participants and carers were qualitatively interviewed before intervention delivery about their expectations and participants; nominated carers and facilitators were all interviewed after cessation about their experiences. RESULTS: The manualised intervention and modes of delivery proved acceptable to participants and carers. Reported benefits included increased confidence and self-efficacy, engagement in new or lapsed activities and re-engagement in fun and friendships. People with dementia and carers were able to self-complete all outcome measures, but time required to complete the measures is a key factor. Strategies for recruitment need to include direct contact within 24-48 h post invitation to the study. Analysis of data on the primary outcome did not reveal any trends. Facilitators found the training and support to be appropriate and helpful. CONCLUSIONS: The tailored intervention reportedly met the needs of all participants. The study confirmed the need for careful identification and application of patient-reported outcome measures. Outcomes to measure some dimensions of reported benefit are not available. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67209155.

Qualitative evaluation of the SMART2 self-management system for people in chronic pain.

PURPOSE: Technology could support the self-management of long-term health conditions such as chronic pain. This article describes an evaluation of SMART2, a personalised self-management system incorporating activity planning and review, feedback on behaviour- and acceptance-based therapeutic exercises. METHOD: The SMART2 system was evaluated over a four-week trial in the homes of people in chronic pain. At conclusion, participants were interviewed to understand the experience of using and living with the SMART2 system as a therapeutic tool. RESULTS: Qualitative analysis of the interviews found that participants liked the system and reported making associated changes to their behaviour. Goal setting and feedback were the most useful elements of the system. A third key and unexpected element was that by simulating some of the functions of a therapist, SMART2 also simulated some of the process of interacting with a therapist. CONCLUSIONS: People in chronic pain may experience positive outcomes when using a self-management system designed for behaviour change. Furthermore, some of the supportive aspects of the therapeutic context can be elicited by self-management technologies. Implications of Rehabilitation Self-management technology has the potential to assist rehabilitation by supporting goal setting and providing feedback. By simulating some of the functions of a therapist, technology can simulate some of the process of therapy during rehabilitation. People in chronic pain liked using the technology in their own home and thought it could augment services delivered by clinical practitioners. Complex programmes of therapeutic exercises delivered by technology had limited success in engaging people in chronic pain.

The SMART personalised self-management system for congestive heart failure: results of a realist evaluation.

BACKGROUND: Technology has the potential to provide support for self-management to people with congestive heart failure (CHF). This paper describes the results of a realist evaluation of the SMART Personalised Self-Management System (PSMS) for CHF. METHODS: The PSMS was used, at home, by seven people with CHF. Data describing system usage and usability as well as questionnaire and interview data were evaluated in terms of the context, mechanism and outcome hypotheses (CMOs) integral to realist evaluation. RESULTS: The CHF PSMS improved heart failure related knowledge in those with low levels of knowledge at baseline, through providing information and quizzes. Furthermore, participants perceived the self-regulatory aspects of the CHF PSMS as being useful in encouraging daily walking. The CMOs were revised to describe the context of use, and how this influences both the mechanisms and the outcomes. CONCLUSIONS: Participants with CHF engaged with the PSMS despite some technological problems. Some positive effects on knowledge were observed as well as the potential to assist with changing physical activity behaviour. Knowledge of CHF and physical activity behaviour change are important self-management targets for CHF, and this study provides evidence to direct the further development of a technology to support these targets.

A pilot randomised controlled trial of a Telehealth intervention in patients with chronic obstructive pulmonary disease: challenges of clinician-led data collection.

BACKGROUND: The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease (COPD) is unsustainable, and focus is needed on self-management and prevention of hospital admissions. Telehealth monitoring of patients' vital signs allows clinicians to prioritise their workload and enables patients to take more responsibility for their health. This paper reports the results of a pilot randomised controlled trial (RCT) of Telehealth-supported care within a community-based COPD supported-discharge service. METHODS: A two-arm pragmatic pilot RCT was conducted comparing the standard service with a Telehealth-supported service and assessed the potential for progressing into a full RCT. The co-primary outcome measures were the proportion of COPD patients readmitted to hospital and changes in patients' self-reported quality of life. The objectives were to assess the suitability of the methodology, produce a sample size calculation for a full RCT, and to give an indication of cost-effectiveness for both pathways. RESULTS: Sixty three participants were recruited (n = 31 Standard; n = 32 Telehealth); 15 participants were excluded from analysis due to inadequate data completion or withdrawal from the Telehealth arm. Recruitment was slow with significant gaps in data collection, due predominantly to an unanticipated 60% reduction of staff capacity within the clinical team. The sample size calculation was guided by estimates of clinically important effects and COPD readmission rates derived from the literature. Descriptive analyses showed that the standard service group had a lower proportion of patients with hospital readmissions and a greater increase in self-reported quality of life compared to the Telehealth-supported group. Telehealth was cost-effective only if hospital admissions data were excluded. CONCLUSIONS: Slow recruitment rates and service reconfigurations prevented progression to a full RCT. Although there are advantages to conducting an RCT with data collection conducted by a frontline clinical team, in this case, challenges arose when resources within the team were reduced by external events. Gaps in data collection were resolved by recruiting a research nurse. This study reinforces previous findings regarding the difficulty of undertaking evaluation of complex interventions, and provides recommendations for the introduction and evaluation of complex interventions within clinical settings, such as prioritisation of research within the clinical remit. TRIAL REGISTRATION: Current Controlled Trials ISRCTN68856013, registered Nov 2010.

'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial.

BACKGROUND: Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. METHODS: Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. RESULTS: We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). CONCLUSIONS: Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre, and/or involve dedicated management of volunteers. TRIAL REGISTRATION: ISRCTN28645428.

Achieving Ecological Validity of Occupation-Based Interventions for Healthy Aging.

AIM: To develop a culturally sensitive occupation-based health promotion intervention for older Hispanic adults who live alone. METHODS: We used a mixed method design for the content validation of the intervention and the Ecological Validity Model (EVM) to culturally center the intervention. In the quantitative phase, aging experts as well as community members from two activity centers for the elderly in Puerto Rico completed a content validity ratio exercise. In the qualitative phase, we conducted three focus groups with these participants. Data analysis included content validity ratio and a directed content analysis. RESULTS: This resulted in a working version of the intervention protocol addressing the eight dimensions of the EVM. CONCLUSIONS: The EVM can be used to culturally center preventive interventions to other ethnic minority groups to augment the external validity and cultural competence of interventions. Future research must test the feasibility of this new intervention.

Lifestyle Matters for maintenance of health and wellbeing in people aged 65 years and over: study protocol for a randomised controlled trial.

BACKGROUND: Healthy, active ageing is strongly associated with good mental wellbeing which in turn helps to prevent mental illness. However, more investment has been made into research into interventions to prevent mental illness than into those designed to improve mental wellbeing. This applied research programme will provide high quality evidence for an intervention designed to improve and sustain mental wellbeing in older adults. METHODS/DESIGN: This study was a multi-centre, pragmatic, two-arm, parallel group, individually randomised controlled trial to determine the population benefit of an occupational therapy based intervention for community living people aged 65 years or older. Participants (n = 268) will be identified in one city in the North of England and in North Wales through GP mail-outs, signposting by local authority, primary care staff and voluntary sector organisations and through community engagement. Participants will be randomised to one of two treatment arms: an intervention (Lifestyle Matters programme); or control (routine access to health and social care). All participants will be assessed at baseline, 6 and 24 months post-randomisation. The primary outcome, which is a person reported outcome, is the SF-36 Mental Health dimension at six months post randomisation. Secondary outcome measures have been selected to measure psychosocial, physical and mental health outcomes. They include other dimensions of the SF36, EQ-5D-3L, Brief Resilience Scale, General Perceived Self Efficacy Scale, PHQ-9, de Jong Gierveld Loneliness Scale, Health and Social Care Resource Use and the wellbeing question of the Integrated Household Survey 2011. A cost effectiveness analysis will investigate the incremental cost per Quality Adjusted Life Years (QALYs) of the Lifestyle Matters intervention compared with treatment as usual. DISCUSSION: The questions being posed through this research are important given the increasing numbers of older people, pressure on the public purse and the associated need to support good health in the extended lifespan. The proposed trial will determine the clinical and cost effectiveness of the intervention delivered in a UK context. The results will support commissioners and providers with decisions about implementation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67209155.

What should be in a self-management programme for people with early dementia?

OBJECTIVES: First, to use participative research methods to obtain views from people with dementia and carers about their experiences and the interventions that they consider can assist in facilitating independence and quality of life post diagnosis. Second, to use these views to identify priority topics for a potential self-management programme. Third, to explore the relevance of the identified topics with a consultation group of people with dementia and their carers, thus informing the creation of a draft self-management programme. METHOD: A series of individual and dyad interviews were conducted with people with dementia and family carers to explore their experiences post diagnosis and obtain views of how quality life can be maintained while living with dementia. A further group of people with dementia and carers then met over six successive weeks to explore and provide feedback on the topic areas generated out of the initial interviews and add to the content. RESULTS: Data generated from the individual interviews identified a number of themes for a potential self-management group which were then validated through consultation. Optimum modes of delivery of a self-management programme were also indicated. CONCLUSIONS: A draft programme has been constructed building upon the framework of identified priorities. The process and outputs from the consultation also indicated the significant ramifications of such a programme for services.

Technology-mediated therapy for chronic pain management: the challenges of adapting behavior change interventions for delivery with pervasive communication technology.

OBJECTIVE: Adapting therapeutic practice from traditional face-to-face exchange to remote technology-based delivery presents challenges for the therapist, patient, and technical writer. This article documents the process of therapy adaptation and the resultant specification for the SMART2 project-a technology-based self-management system for assisting long-term health conditions, including chronic pain. MATERIALS AND METHODS: Focus group discussions with healthcare professionals and patients were conducted to inform selection of therapeutic objectives and appropriate technology. RESULTS: Pertinent challenges are identified, relating to (1) reduction and definition of therapeutic objectives, and (2) how to approach adaptation of therapy to a form suited to technology delivery. The requirement of the system to provide dynamic and intelligent responses to patient experience and behavior is also emphasized. CONCLUSION: Solutions to these challenges are described in the context of the SMART2 technology-based intervention. More explicit discussion and documentation of therapy adaptation to technology-based delivery within the literature is encouraged.

Preventative tele-health supported services for early stage chronic obstructive pulmonary disease: a protocol for a pragmatic randomized controlled trial pilot.

BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is a prevalent debilitating long term condition. It is the second most common cause of emergency admission to hospital in the UK and remains one of the most costly conditions to treat through acute care.Tele-health monitoring offers potential to reduce the rates of re-hospitalisation and emergency department visits and improve quality of life for people with COPD. However, the current evidence base to support technology adoption and implementation is limited and the resource implications for implementing tele-health in practice can be very high. This trial will employ tele-health monitoring in a preventative capacity for patients diagnosed with early stage COPD following discharge from hospital to determine whether it reduces their need for additional health service support or hospital admission and improves their quality of life. METHODS/DESIGN: We describe a pilot study for a two arm, one site randomized controlled trial (RCT) to determine the effect of tele-health monitoring on self-management, quality of life and patient satisfaction. Sixty patients who have been discharged from one acute trust with a primary diagnosis of COPD and who have agreed to receive community clinical support following discharge from acute care will be randomly assigned to one of two groups: (a) Tele-health supported Community COPD Service; or (b) Usual Care. The tele-health supported service involves the patient receiving two home visits with a specialist COPD clinician (nurse or physiotherapist) then participating in daily tele-monitoring over an eight week period. Usual care consists of six home visits to the patient by specialist COPD clinicians again over eight successive weeks. Health status and quality of life data for all participants will be measured at baseline, on discharge from the service and at six months post discharge from the service. DISCUSSION: The tele-health service under study is a complex service delivered through a collaboration between local authority and health care partners. The implementation of this service demanded significant changes to established working patterns and has been a challenging process requiring considerable planning - a challenge that many providers are likely to face in the future. TRIAL REGISTRATION: Current Controlled Trials ISRCTN68856013.

Technologically-assisted behaviour change: a systematic review of studies of novel technologies for the management of chronic illness.

A systematic review was conducted to investigate the use of technology in achieving behaviour change in chronic illness. The areas reviewed were: (1) methods employed to adapt traditional therapy from a face-to-face medium to a computer-assisted platform; (2) targets of behaviour change; and (3) level of human (e.g. therapist) involvement. The initial literature search produced 2032 articles. A total of 45 articles reporting 33 separate interventions met the inclusion/exclusion criteria and were reviewed in detail. The majority of interventions reported a theoretical basis, with many arising from a cognitive-behavioural framework. There was a wide range of therapy content. Therapist involvement was reported in 73% of the interventions. A common problem was high participant attrition, which may have been related to reduced levels of human interaction. Instigating successful behaviour change through technological interventions poses many difficulties. However, there are potential benefits of delivering therapy in this way. For people with long-term health conditions, technological self-management systems could provide a practical method of understanding and monitoring their condition, as well as therapeutic guidance to alter maladaptive behaviour.