Process evaluation of a randomised pilot trial of home-based rehabilitation compared to usual care in patients with heart failure with preserved ejection fraction and their caregiver's.

BACKGROUND: Whilst almost 50% of heart failure (HF) patients have preserved ejection fraction (HFpEF), evidence-based treatment options for this patient group remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. METHODS: Process evaluation sub-study parallels to a single-centre (Tayside, Scotland) randomised controlled pilot trial with qualitative assessment of both intervention fidelity delivery and HFpEF patients' and caregivers' experiences. The REACH-HF intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Interviews were conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and seven caregivers. RESULTS: Qualitative information from the facilitator interactions and interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) responses to the REACH-HF intervention. Fidelity analysis found the interventions to be delivered adequately with scope for improvement in caregiver engagement. The differing professional backgrounds of REACH-HF facilitators in this study demonstrate the possibility of delivery of the intervention by healthcare staff with expertise in HF, cardiac rehabilitation, or both. CONCLUSIONS: The REACH-HF home-based facilitated intervention for HFpEF appears to be a feasible and a well-accepted model for the delivery of rehabilitation, with the potential to address key unmet needs of patients and their caregivers who are often excluded from HF and current cardiac rehabilitation programmes. Results of this study will inform a recently funded full multicentre randomised clinical trial. TRIAL REGISTRATION: ISRCTN78539530 (date of registration 7 July 2015).

The value of social practice theory for implementation science: learning from a theory-based mixed methods process evaluation of a randomised controlled trial.

BACKGROUND: Although there is trial evidence that complex interventions are effective for the self-management of heart failure, little evidence supports their effectiveness in routine practice. We used Social Practice Theory to guide a Type 1 Hybrid Trial: a mixed methods process evaluation of a complex intervention for heart failure. The objective of this paper is to explore the value of Social Practice Theory for implementation science. METHODS: Social Practice Theory informed a mixed methods process evaluation of a multi-centre randomised controlled trial of a 12 week home-based intervention to optimise self-care support for people with heart failure and their caregivers - Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF). Interviews were conducted with 19 people with heart failure and 17 caregivers at 4 months and 12 months after recruitment into the trial. Cases were constructed at the level of the individual, couple, facilitator and centre; and included multi-modal process and outcome data. Evaluative coding and subsequent within- and cross-case analyses enabled the development of a typology of relationships linking fidelity of intervention delivery and tailoring of content to individual needs and concerns. Social Practice Theory was used to interrogate the relationships between elements of the intervention and their implementation. RESULTS: Of 216 trial participants, 107 were randomised to the intervention (REACH-HF plus usual care). The intervention was most effective when fidelity was high and delivery was tailored to the individual's needs, but less effective when both tailoring and fidelity were low. Theory-based analysis enabled us to model complex relationships between intervention elements (competencies, materials and meanings) and social context. The findings illustrate how intervention fidelity and tailoring are contextual and how the effectiveness of the REACH-HF intervention depended on both optimal alignment and implementation of these elements. CONCLUSION: The study demonstrates the utility of theory-based analysis which integrates data from multiple sources to highlight contexts and circumstances in which interventions work best. Social Practice Theory provides a framework for guiding and analysing the processes by which a complex intervention is evaluated in a clinical trial, and has the potential to guide context-specific implementation strategies for clinical practice. TRIAL REGISTRATION: ISRCTN, IISRCTN86234930 . Registered 13th November 2014.

Outcome measures in a combined exercise rehabilitation programme for adults with COPD and chronic heart failure: A preliminary stakeholder consensus event.

Combined exercise rehabilitation for chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) is potentially attractive. Uncertainty remains as to the baseline profiling assessments and outcome measures that should be collected within a programme. Current evidence surrounding outcome measures in cardiac and pulmonary rehabilitation were presented by experts at a stakeholder consensus event and all stakeholders (n = 18) were asked to (1) rank in order of importance a list of categories, (2) prioritise outcome measures and (3) prioritise baseline patient evaluation measures that should be assessed in a combined COPD and CHF rehabilitation programme. The tasks were completed anonymously and related to clinical rehabilitation programmes and associated research. Health-related quality of life, exercise capacity and symptom evaluation were voted as the most important categories to assess for clinical purposes (median rank: 1, 2 and 3 accordingly) and research purposes (median rank; 1, 3 and 4.5 accordingly) within combined exercise rehabilitation. All stakeholders agreed that profiling symptoms at baseline were 'moderately', 'very' or 'extremely' important to assess for clinical and research purposes in combined rehabilitation. Profiling of frailty was ranked of the same importance for clinical purposes in combined rehabilitation. Stakeholders identified a suite of multidisciplinary measures that may be important to assess in a combined COPD and CHF exercise rehabilitation programme.

Involving caregivers in self-management interventions for patients with heart failure and chronic obstructive pulmonary disease. A systematic review and meta-analysis.

AIM: To quantify the impact of involving caregivers in self-management interventions on health-related quality of life of patients with heart failure or chronic obstructive pulmonary disease. DESIGN: Systematic review, meta-analysis. DATA SOURCES: Searched: Medline Ebsco, PsycINFO, CINAHL, Embase, Web of Science, The British Library and ProQuest. Search time frame; January 1990-March 2018. REVIEW METHODS: Randomized controlled trials involving caregivers in self-management interventions (≥2 components) compared with usual care for patients with heart failure or chronic obstructive pulmonary disease. A matched sample based on publication year, geographic location and inclusion of an exercise intervention of studies not involving caregivers were identified. Primary outcome of analysis was patient health-related quality of life. RESULTS: Thirteen randomized controlled trials (1,701 participants: 1,439 heart failure; 262 chronic obstructive pulmonary disease) involving caregivers (mean age 59; 58% female) were identified. Reported patient health-related quality of life measures included; Minnesota Living with Heart Failure questionnaire, St. George's respiratory questionnaire and Short-Form-36. Compared with usual care, there was similar magnitude in mean improvement in patient health-related quality of life with self-management interventions in trials involving caregivers (SMD: 0.23, 95% confidence interval: -0.15-0.61) compared with trials without caregivers (SMD: 0.27, 0.08-0.46). CONCLUSION: Within the methodological constraints of this study, our results indicate that involving caregivers in self-management interventions does not result in additional improvement in patient health-related quality of life in heart failure or chronic obstructive pulmonary disease. However, involvement of caregivers in intervention delivery remains an important consideration and key area of research. IMPACT: Greater understanding and awareness is needed of the methodology of caregiver engagement in intervention development and delivery and its impact on patient outcomes.

Home-based rehabilitation for heart failure with reduced ejection fraction: mixed methods process evaluation of the REACH-HF multicentre randomised controlled trial.

OBJECTIVE: To identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives. DESIGN: Mixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care). SETTING: Four centres in the UK (Birmingham, Cornwall, Gwent and York). PARTICIPANTS: People with heart failure with reduced ejection fraction (HFrEF) and their caregivers. METHODS: The REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers. OUTCOME MEASURES: Quantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers. RESULTS: Intervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents' comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life. CONCLUSIONS: By combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention. TRIAL REGISTRATION NUMBER: ISRCTN25032672; Pre-results.

Is virtual clinic follow-up of hip and knee joint replacement acceptable to patients and clinicians? A sequential mixed methods evaluation.

Objective: To evaluate the acceptability to key stake holders of a newly introduced virtual clinic follow-up pathway for hip and knee joint replacement. Design: A service evaluation comprising a questionnaire sent electronically to 115 patients and interviews with 10 individuals. Setting: A newly introduced virtual clinic follow-up pathway for hip and knee replacement patients in a district general hospital. Participants: The electronic questionnaire was distributed to all patients treated under the virtual clinic service over a 5-month period (n=115). Purposive sampling from volunteers among respondents, leading to semi-structured interviews with eight patients. Two orthopaedic consultants were also interviewed. Intervention: Consultant review of web-based patient reported outcome measures and digital radiographs, with feedback to patients via letter, replacing face-to-face outpatient appointments for the follow-up of hip and knee joint replacement. Results: The response rate to the questionnaire was 40%. 44% indicated they would prefer a virtual appointment over a face-to-face consultation in future. The most common word in the free text comments was 'good' (n=107).Seven main themes were identified from the patient interviews: patient understanding and expectations, patient confidence, patient voice, managing deterioration of condition, patient benefit, patient satisfaction using technology and navigating the website.Two main themes were identified from the staff interviews: the adapting patient pathway and project management.Combined analysis elucidated that patients who were doing well liked the 'click and go' approach but those with problems were concerned about how to report these and were therefore less satisfied. Conclusion: The virtual clinic process appears to be well accepted by both patients and clinicians. However, appropriate patient selection and clear pathways of communication to address patient concerns are pivotal to success.

Caregiver outcomes of the REACH-HF multicentre randomized controlled trial of home-based rehabilitation for heart failure with reduced ejection fraction.

BACKGROUND: Caregivers frequently provide support to people living with long-term conditions. However, there is paucity of evidence of interventions that support caregivers in their role. Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF) is a novel home-based, health-professional-facilitated, self-management programme for patients with heart failure (HF) and their caregivers. METHODS: Based on the random allocation of individual adult patients with reduced ejection fraction (HFrEF) and left ventricular ejection fraction <45% within the past five years, the caregiver of patients was allocated to receive the REACH-HF intervention over 12 weeks (REACH-HF group) or not (control group). Caregiver outcomes were generic health-related quality of life (EQ-5D-5L), Family Caregiver Quality of Life Scale questionnaire (FamQol), Caregiver Burden Questionnaire HF (CBQ-HF), Caregiver Contribution to Self-care of HF Index questionnaire (CC-SCHFI) and Hospital Anxiety and Depression Scale (HADS). Outcomes were compared between groups at 4, 6 and 12 months follow-up. Twenty caregivers receiving REACH-HF were purposively selected for qualitative interviews at 4 and 12 months. RESULTS: Compared with controls (44 caregivers), the REACH-HF group (53 caregivers) had a higher mean CC-SCHFI confidence score at 12 months (57.5 vs 62.8, adjusted mean difference: 9.3, 95% confidence interval: 1.8-16.8, p = 0.016). No significant between group differences were seen in other caregiver outcomes. Qualitative interviews showed that most caregivers who received the REACH-HF intervention made positive changes to how they supported the HF patient they were caring for, and perceived that they had increased their confidence in the caregiver role over time. CONCLUSION: Provision of the REACH-HF intervention for caregivers of HF patients improved their confidence of self-management and was perceived for some to be helpful in supporting their caregiver role.

The cost effectiveness of REACH-HF and home-based cardiac rehabilitation compared with the usual medical care for heart failure with reduced ejection fraction: A decision model-based analysis.

BACKGROUND: The REACH-HF (Rehabilitation EnAblement in CHronic Heart Failure) trial found that the REACH-HF home-based cardiac rehabilitation intervention resulted in a clinically meaningful improvement in disease-specific health-related quality of life in patients with reduced ejection fraction heart failure (HFrEF). The aims of this study were to assess the long-term cost-effectiveness of the addition of REACH-HF intervention or home-based cardiac rehabilitation to usual care compared with usual care alone in patients with HFrEF. DESIGN AND METHODS: A Markov model was developed using a patient lifetime horizon and integrating evidence from the REACH-HF trial, a systematic review/meta-analysis of randomised trials, estimates of mortality and hospital admission and UK costs at 2015/2016 prices. Taking a UK National Health and Personal Social Services perspective we report the incremental cost per quality-adjusted life-year (QALY) gained, assessing uncertainty using probabilistic and deterministic sensitivity analyses. RESULTS: In base case analysis, the REACH-HF intervention was associated with per patient mean QALY gain of 0.23 and an increased mean cost of £400 compared with usual care, resulting in a cost per QALY gained of £1720. Probabilistic sensitivity analysis indicated a 78% probability that REACH-HF is cost effective versus usual care at a threshold of £20,000 per QALY gained. Results were similar for home-based cardiac rehabilitation versus usual care. Sensitivity analyses indicate the findings to be robust to changes in model assumptions and parameters. CONCLUSIONS: Our cost-utility analyses indicate that the addition of the REACH-HF intervention and home-based cardiac rehabilitation programmes are likely to be cost-effective treatment options versus usual care alone in patients with HFrEF.

The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial.

BACKGROUND: Cardiac rehabilitation improves health-related quality of life (HRQoL) and reduces hospitalizations in patients with heart failure, but international uptake of cardiac rehabilitation for heart failure remains low. DESIGN AND METHODS: The aim of this multicentre randomized trial was to compare the REACH-HF (Rehabilitation EnAblement in CHronicHeart Failure) intervention, a facilitated self-care and home-based cardiac rehabilitation programme to usual care for adults with heart failure with reduced ejection fraction (HFrEF). The study primary hypothesis was that the addition of the REACH-HF intervention to usual care would improve disease-specific HRQoL (Minnesota Living with Heart Failure questionnaire (MLHFQ)) at 12 months compared with usual care alone. RESULTS: The study recruited 216 participants, predominantly men (78%), with an average age of 70 years and mean left ventricular ejection fraction of 34%. Overall, 185 (86%) participants provided data for the primary outcome. At 12 months, there was a significant and clinically meaningful between-group difference in the MLHFQ score of -5.7 points (95% confidence interval -10.6 to -0.7) in favour of the REACH-HF intervention group ( p = 0.025). With the exception of patient self-care ( p < 0.001) there was no significant difference in other secondary outcomes, including clinical events ( p > 0.05) at follow-up compared with usual care. The mean cost of the REACH-HF intervention was £418 per participant. CONCLUSIONS: The novel REACH-HF home-based facilitated intervention for HFrEF was clinically superior in disease-specific HRQoL at 12 months and offers an affordable alternative to traditional centre-based programmes to address current low cardiac rehabilitation uptake rates for heart failure.

Trial of intraoperative cell salvage versus transfusion in ovarian cancer (TIC TOC): protocol for a randomised controlled feasibility study.

INTRODUCTION: Ovarian cancer is the leading cause of death from gynaecological cancer, with more than 7000 new cases registered in the UK in 2014. In patients suitable for surgery, the National Institute of Health and Care Excellence guidance for treatment recommends surgical resection of all macroscopic tumour, followed by chemotherapy. The surgical procedure can be extensive and associated with substantial blood loss which is conventionally replaced with a donor blood transfusion. While often necessary and lifesaving, the use of donor blood is associated with increased risks of complications and adverse surgical outcomes. Intraoperative cell salvage (ICS) is a blood conservation strategy in which red cells collected from blood lost during surgery are returned to the patient thus minimising the use of donor blood. This is the protocol for a feasibility randomised controlled trial with an embedded qualitative study and feasibility economic evaluation. If feasible, a later definitive trial will test the effectiveness and cost-effectiveness of ICS reinfusion versus donor blood transfusion in ovarian cancer surgery. METHODS AND ANALYSIS: Sixty adult women scheduled for primary or interval ovarian cancer surgery at participating UK National Health Service Trusts will be recruited and individually randomised in a 1:1 ratio to receive ICS reinfusion or donor blood (as required) during surgery. Participants will be followed up by telephone at 30 days postoperatively for adverse events monitoring and by postal questionnaire at 6 weeks and 3 monthly thereafter, to capture quality of life and resource use data. Qualitative interviews will capture participants' and clinicians' experiences of the study. ETHICS AND DISSEMINATION: This study has been granted ethical approval by the South West-Exeter Research Ethics Committee (ref: 16/SW/0256). Results will be disseminated via peer-reviewed publications and will inform the design of a larger trial. TRIAL REGISTRATION NUMBER: ISRCTN19517317.

'Who Cares?' The experiences of caregivers of adults living with heart failure, chronic obstructive pulmonary disease and coronary artery disease: a mixed methods systematic review.

OBJECTIVE: To assess the experiences of unpaid caregivers providing care to people with heart failure (HF) or chronic obstructive pulmonary disease (COPD) or coronary artery disease (CAD). Design Mixed methods systematic review including qualitative and quantitative studies. Data sources Databases searched: Medline Ebsco, PsycInfo, CINAHL Plus with Full Text, Embase, Web of Science, Ethos: The British Library and ProQuest. Grey literature identified using: Global Dissertations and Theses and Applied Sciences Index and hand searches and citation checking of included references. Search time frame: 1 January 1990 to 30 August 2017. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Inclusion was limited to English language studies in unpaid adult caregivers (>18 years), providing care for patients with HF, COPD or CAD. Studies that considered caregivers for any other diagnoses and studies undertaken in low-income and middle-income countries were excluded. Quality assessment of included studies was conducted by two authors. DATA ANALYSIS/SYNTHESIS: A results-based convergent synthesis was conducted. RESULTS: Searches returned 8026 titles and abstracts. 54 studies-21 qualitative, 32 quantitative and 1 mixed method were included. This totalled 26 453 caregivers who were primarily female (63%), with median age of 62 years. Narrative synthesis yielded six concepts related to caregiver experience: (1) mental health, (2) caregiver role, (3) lifestyle change, (4) support for caregivers, (5) knowledge and (6) relationships. There was a discordance between paradigms regarding emerging concepts. Four concepts emerged from qualitative papers which were not present in quantitative papers: (1) expert by experience, (2) vigilance, (3) shared care and (4) time. CONCLUSION: Caregiving is life altering and complex with significant health implications. Health professionals should support caregivers who in turn can facilitate the recipient to manage their long-term condition. Further longitudinal research exploring the evolution of caregiver experiences over time of patients with chronic cardiopulmonary conditions is required. TRIAL REGISTRATION NUMBER: CRD42016053412.

A randomised controlled trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers: the REACH-HFpEF Pilot Study.

INTRODUCTION: Home-based cardiac rehabilitation may overcome suboptimal rates of participation. The overarching aim of this study was to assess the feasibility and acceptability of the novel Rehabilitation EnAblement in CHronic Hear Failure (REACH-HF) rehabilitation intervention for patients with heart failure with preserved ejection fraction (HFpEF) and their caregivers. METHODS AND RESULTS: Patients were randomised 1:1 to REACH-HF intervention plus usual care (intervention group) or usual care alone (control group). REACH-HF is a home-based comprehensive self-management rehabilitation programme that comprises patient and carer manuals with supplementary tools, delivered by trained healthcare facilitators over a 12 week period. Patient outcomes were collected by blinded assessors at baseline, 3 months and 6 months postrandomisation and included health-related quality of life (primary) and psychological well-being, exercise capacity, physical activity and HF-related hospitalisation (secondary). Outcomes were also collected in caregivers.We enrolled 50 symptomatic patients with HF from Tayside, Scotland with a left ventricular ejection fraction ≥45% (mean age 73.9 years, 54% female, 100% white British) and 21 caregivers. Study retention (90%) and intervention uptake (92%) were excellent. At 6 months, data from 45 patients showed a potential direction of effect in favour of the intervention group, including the primary outcome of Minnesota Living with Heart Failure Questionnaire total score (between-group mean difference -11.5, 95% CI -22.8 to 0.3). A total of 11 (4 intervention, 7 control) patients experienced a hospital admission over the 6 months of follow-up with 4 (control patients) of these admissions being HF-related. Improvements were seen in a number intervention caregivers' mental health and burden compared with control. CONCLUSIONS: Our findings support the feasibility and rationale for delivering the REACH-HF facilitated home-based rehabilitation intervention for patients with HFpEF and their caregivers and progression to a full multicentre randomised clinical trial to test its clinical effectiveness and cost-effectiveness. TRIAL REGISTRATION NUMBER: ISRCTN78539530.

Behind the smile: qualitative study of caregivers' anguish and management responses while caring for someone living with heart failure.

BACKGROUND: Caregivers support self-management in heart failure but often experience stress, anxiety and ill health as a result of providing care. AIMS: 1. To identify the factors that contribute to the experience of anguish.2. To understand how caregivers learn to live with what is frequently a challenging and demanding role. METHODS: Individual interviews with caregivers who had been caring for someone with heart failure for a minimum of 6 months. We used thematic analysis to inductively analyse transcripts. RESULTS: Twenty-two caregivers, from three centres in the United Kingdom, took part in individual interviews. The caregivers were aged between 39 and 84 years, and six were men. Twenty were in spousal or partner relationships. We found that caregivers often hide the extent of their emotional stress or anguish. We identified four main themes with explanatory subthemes-emotional impact (fear for the future and sense of hopelessness), role definition (changing sense of who I am, reduced resilience, learning care skills, role conflict and changing role), exclusion (exclusion by the cared-for person and by health professionals and feeling alone) and ignoring one's own health-that were associated with anguish. From these findings, we produced a caregiver needs assessment model in the context of caring for a person with heart failure. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Caregivers have many unmet and hidden needs. Primary care health professionals are well placed to meet the needs of caregivers. The model may be used by health and social care professionals to identify needs and to provide caregivers with targeted practical and emotional support; and for researchers developing interventions to enhance self-management in heart failure.

Does the use of Nintendo Wii SportsTM improve arm function? Trial of WiiTM in Stroke: a randomized controlled trial and economics analysis.

OBJECTIVE: The Trial of Wii™ in Stroke investigated the efficacy of using the Nintendo Wii Sports™ (WiiTM) to improve affected arm function after stroke. DESIGN: Multicentre, pragmatic, parallel group, randomized controlled trial. SETTING: Home-based rehabilitation. SUBJECTS: A total of 240 participants aged 24-90 years with arm weakness following a stroke within the previous six months. INTERVENTION: Participants were randomly assigned to exercise daily for six weeks using the WiiTM or arm exercises at home. MAIN MEASURES: Primary outcome was change in the affected arm function at six weeks follow-up using the Action Research Arm Test. Secondary outcomes included occupational performance, quality of life, arm function at six months and a cost effectiveness analysis. RESULTS: The study was completed by 209 participants (87.1%). There was no significant difference in the primary outcome of affected arm function at six weeks follow-up (mean difference -1.7, 95% CI -3.9 to 0.5, p = 0.12) and no significant difference in secondary outcomes, including occupational performance, quality of life or arm function at six months, between the two groups. No serious adverse events related to the study treatment were reported. The cost effectiveness analysis showed that the WiiTM was more expensive than arm exercises £1106 (SD 1656) vs. £730 (SD 829) (probability 0.866). CONCLUSION: The trial showed that the WiiTM was not superior to arm exercises in home-based rehabilitation for stroke survivors with arm weakness. The WiiTM was well tolerated but more expensive than arm exercises.

Optimising self-care support for people with heart failure and their caregivers: development of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention using intervention mapping.

BACKGROUND: We aimed to establish the support needs of people with heart failure and their caregivers and develop an intervention to improve their health-related quality of life. METHODS: We used intervention mapping to guide the development of our intervention. We identified "targets for change" by synthesising research evidence and international guidelines and consulting with patients, caregivers and health service providers. We then used behaviour change theory, expert opinion and a taxonomy of behaviour change techniques, to identify barriers to and facilitators of change and to match intervention strategies to each target. A patient and public involvement group helped to identify patient and caregiver needs, refine the intervention objectives and strategies and deliver training to the intervention facilitators. A feasibility study (ISRCTN25032672) involving 23 patients, 12 caregivers and seven trained facilitators at four sites assessed the feasibility and acceptability of the intervention and quality of delivery and generated ideas to help refine the intervention. RESULTS: The Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention is a comprehensive self-care support programme comprising the "Heart Failure Manual", a choice of two exercise programmes for patients, a "Family and Friends Resource" for caregivers, a "Progress Tracker" tool and a facilitator training course. The main targets for change are engaging in exercise training, monitoring for symptom deterioration, managing stress and anxiety, managing medications and understanding heart failure. Secondary targets include managing low mood and smoking cessation. The intervention is facilitated by trained healthcare professionals with specialist cardiac experience over 12 weeks, via home and telephone contacts. The feasibility study found high levels of satisfaction and engagement with the intervention from facilitators, patients and caregivers. Intervention fidelity analysis and stakeholder feedback suggested that there was room for improvement in several areas, especially in terms of addressing caregivers' needs. The REACH-HF materials were revised accordingly. CONCLUSIONS: We have developed a comprehensive, evidence-informed, theoretically driven self-care and rehabilitation intervention that is grounded in the needs of patients and caregivers. A randomised controlled trial is underway to assess the effectiveness and cost-effectiveness of the REACH-HF intervention in people with heart failure and their caregivers.

Needs of caregivers in heart failure management: A qualitative study.

OBJECTIVES: To identify the needs of caregivers supporting a person with heart failure and to inform the development of a caregiver resource to be used as part of a home-based self-management programme. METHODS: A qualitative study informed by thematic analysis involving 26 caregivers in individual interviews or a focus group. RESULTS: Three distinct aspects of caregiver support in heart failure management were identified. Firstly, caregivers identified needs about supporting management of heart failure including: coping with the variability of heart failure symptoms, what to do in an emergency, understanding and managing medicines, providing emotional support, promoting exercise and physical activity, providing personal care, living with a cardiac device and supporting depression management. Secondly, as they make the transition to becoming a caregiver, they need to develop skills to undertake difficult discussions about the role; communicate with health professionals; manage their own mental health, well-being and sleep; and manage home and work. Thirdly, caregivers require skills to engage social support, and voluntary and formal services while recognising that the long-term future is uncertain. DISCUSSION: The identification of the needs of caregiver has been used to inform the development of a home-based heart failure intervention facilitated by a trained health care practitioner.

Does the use of Nintendo Wii Sports™ improve arm function and is it acceptable to patients after stroke? Publication of the Protocol of the Trial of Wii™ in Stroke - TWIST.

INTRODUCTION: Many stroke patients experience loss of arm function requiring rehabilitation, which is expensive, repetitive, and does not always translate into "real life." Nintendo Wii Sports™ (Wii™) may offer task-specific training that is repetitive and motivating. The Trial of Wii™ in Stroke (TWIST) is designed to investigate feasibility, efficacy, and acceptability using Wii™ to improve affected arm function for patients after stroke. METHOD: This is a randomized controlled trial (RCT), incorporating a qualitative study and health economics analysis that compares playing Wii™ versus arm exercises in patients receiving standard rehabilitation in a home setting within 6 months of stroke with a motor deficit of less than 5 on the MRC (Medical Research Council) scale (arm). In this study, we expect to randomize 240 participants. OUTCOME MEASURES: Primary outcome is change in affected arm function at 6 weeks follow-up in intervention and control group using the Action Research Arm Test. Secondary outcomes include occupational performance using the Canadian Occupational Performance Measure, quality of life using the Stroke Impact Scale, cost effectiveness analysis, and a qualitative study investigating factors that influence use of Wii™ for patients and carers. CONCLUSION: TWIST is the first UK RCT assessing the feasibility, cost effectiveness, and acceptability of Wii™ in stroke rehabilitation. The trial has been registered with ISRCTN 06807619 and UK CRN 11030. Results of the study will be published after completion of study in August 2014.

Heart failure patients' attitudes, beliefs, expectations and experiences of self-management strategies: a qualitative synthesis.

OBJECTIVES: To develop a model of heart failure patients' attitudes, beliefs, expectations, and experiences based on published qualitative research that could influence the development of self-management strategies. METHODS: A synthesis of 19 qualitative research studies using the method of meta-ethnography. RESULTS: This synthesis offers a conceptual model of the attitudes, beliefs, and expectations of patients with heart failure. Patients experienced a sense of disruption before developing a mental model of heart failure. Patients' reactions included becoming a strategic avoider, a selective denier, a well-intentioned manager, or an advanced self-manager. Patients responded by forming self-management strategies and finally assimilated the strategies into everyday life seeking to feel safe. DISCUSSION: This conceptual model suggests that there are a range of interplaying factors that facilitate the process of developing self-management strategies. Interventions should take into account patients' concepts of heart failure and their subsequent reactions.

Why do so few patients with heart failure participate in cardiac rehabilitation? A cross-sectional survey from England, Wales and Northern Ireland.

OBJECTIVES: To determine why so few patients with chronic heart failure in England, Wales and Northern Ireland take part in cardiac rehabilitation. DESIGN: Two-stage, postal questionnaire-based national survey. PARTICIPANTS AND SETTING: Stage 1: 277 cardiac rehabilitation centres that provided phase 3 cardiac rehabilitation in England, Wales and Northern Ireland registered on the National Audit of Cardiac Rehabilitation register. Stage 2: 35 centres that indicated in stage 1 that they provide a separate cardiac rehabilitation programme for patients with heart failure. RESULTS: Full data were available for 224/277 (81%) cardiac rehabilitation centres. Only 90/224 (40%) routinely offered phase 3 cardiac rehabilitation to patients with heart failure. Of these 90 centres that offered rehabilitation, 43% did so only when heart failure was secondary to myocardial infarction or revascularisation. Less than half (39%) had a specific rehabilitation programme for heart failure. Of those 134 centres not providing for patients with heart failure, 84% considered a lack of resources and 55% exclusion from commissioning contracts as the reason for not recruiting patients with heart failure. Overall, only 35/224 (16%) centres provided a separate rehabilitation programme for people with heart failure. CONCLUSIONS: Patients with heart failure as a primary diagnosis are excluded from most cardiac rehabilitation programmes in England, Wales and Northern Ireland. A lack of resources and direct exclusion from local commissioning agreements are the main barriers for not offering rehabilitation to patients with heart failure.

Communicating the results of research: how do participants of a cardiac rehabilitation RCT prefer to be informed?

OBJECTIVE: To determine the preferred means by which participants in a study of cardiac rehabilitation wish to be informed of the study's results. DESIGN: Postal questionnaire survey of participants in a randomized controlled trial. SETTING: Cornwall, southwest England. PARTICIPANTS: Patients recruited to the Cornwall Heart Attack Rehabilitation Management Study (CHARMS). METHOD: Participants recruited to CHARMS who were alive 3 years and 9 months after the trial was completed were contacted by letter and invited to return a reply slip with four short questions indicating how they would prefer to be informed about the published results of the study. RESULTS: In March 2008, 191/230 participants originally recruited to CHARMS were still alive. General practitioners deemed 166/191 (88%) survivors medically appropriate to be contacted through a postal survey, and 154/166 (93%) participants responded to the invitation to participate in the follow-up survey. 86% (143/166) of participants indicated that they wished to be informed about the results: 115 (80%) of these elected to receive information by letter and 25 (18%) of these preferred to attend a meeting. Men older than 65 years predominated in this latter group. Women respondents preferred to receive the study results by letter; none preferred communication by email or the web. CONCLUSION: Survivors of acute myocardial infarction who participated in a RCT of cardiac rehabilitation wanted to receive a summary of the aggregate study results. Participants had preferences regarding how they would wish to be informed about the results of the study. Most participants preferred to be informed by letter or email, but some preferred the interaction of a group or a meeting.