Patients with heart failure with preserved ejection fraction and their caregiver’s experiences of home-based rehabilitation (REACH-HFpEF): mixed methods process evaluation of the REACH-HFpEF single centre pilot randomised controlled trial.

Background: Whilst heart failure (HF) with preserved ejection fraction (HFpEF) affects almost 50 percent of the HF population, evidence-based treatment options remain limited. However, there is emerging evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation conducted as part of the REACH-HFpEF trial. Methods: Mixed methods process evaluation parallel to a single centre (Tayside, Scotland) pilot randomised controlled trial with quantitative assessment of intervention fidelity and a qualitative exploration of HFpEF patients’ and caregivers’ experiences. The Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF) intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Data included audio-recorded intervention sessions; demographic information; intervention fidelity scores; and qualitative interviews conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and 7 caregivers, Results: Intervention fidelity analysis was indicative of the adequate delivery of the majority of the REACH-HF components, with three items relating caregiver involvement (addressing emotional consequences of being a caregiver, caregiver health and wellbeing, and closure of the session) scoring poorly. Qualitative interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) patients’ and caregivers’ responses to the REACH-HF intervention were uncovered by qualitative interviews. Conclusions: The REACH-HF home-based facilitated intervention for HFpEF appears feasible and well accepted model for delivery of a CR intervention, with the potential to address key unmet needs of patients and their caregivers who are often excluded from service provision and current CR programmes. Results inform a future full multicentre randomised clinical trial.


Introduction
In the United Kingdom (UK), approximately one million people have heart failure (HF) -a condition resulting in relatively inefficient cardiovascular functioning, often presenting with debilitating symptoms of fatigue, shortness of breath (dyspnoea), reduced exercise capacity, and a potentially dangerous accumulation of fluid in bodily tissues [1]. Almost 50 percent of heart failure (HF) patients have preserved ejection fraction (HFpEF) and its prevalence is predicted to grow [1][2][3]. Although these patients are more often women, generally older, with a higher prevalence of co-morbidities (hypertension, diabetes and atrial fibrillation) and are less likely to have coronary artery disease than those with HF with reduced ejection fraction (HFrEF), their prognosis, associated morbidity, mortality, health-related quality of life (HRQoL) and healthcare costs are comparable [1][2][3].
The health burden of HFpEF on patients, caregivers, the health system and the broader economy, is substantial -with markedly reduced ability to perform activities of daily living, poor health-related quality of life, high rates of unplanned hospitalisations, high costs and premature mortality [4,5]. In contrast to HFrEF, where evidence-based therapies result in improved life expectancy and health-related quality of life, there is an absence of evidence-based treatment options for HFpEF [6]. Drugs or devices shown in trials to be effective for HFrEF, have not successfully altered prognosis in individuals living with HFpEF [7][8][9]. As a result, HFpEF patients and their caregivers are effectively living with untreated HF, with potentially devastating consequences for patients and their families.
In contrast to the neutral outcomes of device and drug trials in the HFpEF population, there is promising evidence indicating that exercise-based cardiac rehabilitation (CR) can benefit people with HFpEF [10]. CR is traditionally delivered in supervised group hospitalbased programmes. However, given the suboptimal uptake of CR in people with HF, there is a need for alternative models of CR delivery, including home-based interventions [11].
The Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is a healthcare professional facilitated home-based rehabilitation intervention designed to improve selfcare and health-related quality of life in people with HF and their caregivers and to improve access to CR [12].
The HFpEF trial was a single centre study with the aim of assessing the feasibility of undertaking a definitive randomised trial to assess the clinical effectiveness and costeffectiveness of the REACH-HF intervention in patients with HFpEF and their caregivers [13]. The findings and the patient, caregiver and cost results of the REACH-HFpEF trial are reported elsewhere [14]. This paper reports on a process evaluation conducted in parallel to the REACH-HFpEF trial that aimed to assess the fidelity of intervention delivery, and patients' and caregivers' experiences of participation in the REACH-HF intervention.

Design
Details of the REACH-HFpEF single centre (Tayside, Scotland) randomised pilot trial have been published elsewhere [13,14]. In brief, 25 HFpEF patients and 11 caregivers were allocated to either the REACH-HF intervention plus usual care (intervention group) and 25 patients and 10 caregivers to usual care alone (control group). Participating patients were aged 18 years or older and had a confirmed diagnosis of HFpEF on echocardiography, radionuclide ventriculography or angiography (ie, left ventricular ejection fraction ≥ 45% within the last 6 months prior to randomisation).
A mixed methods process evaluation was undertaken that undertook a quantitative assessment of the fidelity of REACH-HF delivery and a qualitative exploration of both HFpEF patient and caregiver experiences of the REACH-HF intervention through semistructured interviews. The intervention group formed the sampling frame for the process evaluation. Patients were sampled for maximum variation techniques based on age, gender, presence of a caregiver, and psychological well-being (assessed by Hospital Anxiety Depression Scale [15] providing a purposive subsample of 15 patients and 7 with caregivers who agreed to participate in the qualitative interviews. Six of these patients and caregivers agreed to participate in the fidelity analysis to assess the consistency of what was delivered with the planned intervention.

REACH-HF Intervention
The REACH-HF intervention is a comprehensive 12-week practitioner facilitated self-care support programme co-designed with HF patients, caregivers, and healthcare professionals [12]. It comprises: (1) a patient 'Heart Failure Manual' that provides information and interactive elements which target patients understanding of and adaption to living with HF, their medications, the rationale for engaging in exercise and how to monitor and manage HF associated symptoms and stress. The manual content was modified for this study to reflect relevant medications, causes, and treatment of HFpEF [13]; (2) a 'Progress Tracker' to record, review and monitor symptoms, well-being, physical activity and other self-management behaviours; (3) a choice of exercise training programme (chair based and walking), (4) information of stress managing stress and anxiety (including a relaxation CD); and (5) a 'Family and Friends Resource' for caregivers that provides information to support the HF patients, as well as manage their own health and well-being. REACH-HF participants were supported by one of two nurse facilitators (one with experience in CR and the other in HF) who had undergone a 3-day training course on the intervention. During the 4 to 6 anticipated facilitator contacts (an initial 60-90 minutes face-to-face consultation at their home, up to three further 30-minutes visits, plus 2 to 4 telephone contacts). Facilitator sought to increase the patient and caregiver understanding of living with and self-managing their HF.

Fidelity of intervention delivery
Facilitator interactions with participants were audio recorded and the quality of delivery assessed using a 13-item checklist previously developed by the research team [12,13].
Scoring ranged from 0 -'an absence or very poor delivery' to 6 -'excellent/expert use of techniques for each (predefined) key component of the intervention process. 'Adequate' delivery of the REACH-HF intervention was defined as a score of 3 or more. The fidelity scores are presented descriptively.
Semi-structured qualitative interviews 8 The flow of study participants is shown in Fig. 1. Between April 2015 and June 2016, 50 patient participants were randomised (intervention group 25; control group 25). The characteristics of the intervention group patients and caregivers who participated in the process evaluation as summarised in Table 1. Patients were equally likely to be male or female with an average age of 71-years.
Caregivers were typically a spouse or partner, younger (average age 66-years) and female. The process evaluation sample was representative of the wider intervention group [14].

Fidelity of intervention delivery
The six patients and caregivers included in the fidelity analysis contributed a total of 41 facilitator interactions. Of these, 34 of which were face to face (average duration: 63 minutes, range 10 to 154 minutes) and 7 telephone contacts (average duration: 6 minutes, range 5 to 13 minutes).
Face-to-face contacts were more consistently recorded than telephone contacts. Fidelity was considered to adequate (score of ≥ 3 out of 6) in most of 13 domains (see Table 2).
However, there was room for improvement, particularly with respect to involving the caregiver, addressing caregiver concerns, and addressing caregiver well-being where the average scores were consistently lower. There was no evidence of a substantive differences in fidelity scores between the two facilitators.

Semi-structured qualitative interviews
Interviews lasting an average 42 minutes (range 7 to 70 minutes) were completed in participants homes (21) or by telephone (1). Three overarching themes and their related subthemes emerged from the analyses: (1) understanding their condition, (2) emotional consequences of HF, and (3) response to the intervention.
Theme 1: Understanding their condition Many participants were unaware of their HF diagnosis and its potential severity.
Participants often described a protracted and uncertain path to diagnosis of their HF, with symptoms being masked by other underlying conditions and conflicting diagnostic information being provided by clinicians. For a few participants, particularly those who perceived themselves as 'fit' and healthy, their HF diagnosis was a 'shock' which challenged their current identity.
"… I was shocked, I couldn't believe it. I just couldn't believe, because I've always been very fit" [Patient interview 3] Following diagnosis others reported that they were 'too frightened to do anything'.
However, the majority (13 patients) did not regard their HF as fatal, and believed they could accommodate it in the way they had with their other long term conditions seeing HF a continuation of a biography of adaptation to illness and disability. For many patients, their diagnosis came as a relief because it normalised and explained their symptoms e.g.
tiredness and breathlessness, making them less anxious and enabled them to explain their symptoms and condition to others. The majority felt the description of HF in the manual, combined with the facilitator's explanation, aided their understanding of HF thus equipping them better to untangle, identify and act on HF symptoms. Some avoided reading or asking about HF believing this was 'morbid', and a source of stress which reminded them of the possibility of death.
Similar extremes in perspectives were reported by caregivers with some viewing HF as 'final' (a kind of death sentence), requiring constant surveillance and for this group the role of caregiving was extremely stressful.
"I think when you get diagnosed with heart failure, from my point of view, the very word of heart failure is absolutely terrifying...And the word 'heart failure' is so completely final… you're sort of…you're never relaxing. You're always watching to see he's okay.
You're waking up in the middle of night, if you've got to get up and you're looking at him to make sure he's breathing… And then you think, good, he's just sleeping.…if he's not moving, you think, why hasn't he moved?" [Caregiver Interview 20] In contrast, others perceived that minor changes to health behaviours such as healthy eating and exercise were sufficient to maintain a good health-related quality of life. Most patients said that they followed the exercise recommendations within the manual, and progressed through the chair based exercise programme (delivered by DVD) as advised by the facilitator, either alone or together with their caregiver. A few needed guidance to prevent inappropriately rapid progression through the exercise levels. In contrast, the other two discontinued their exercise programme.
When progress through the exercise levels did not match patients' expectations they were disappointed. The facilitators played an extremely important role, encouraging them, affirming progress and suggesting more appropriate alternative exercise. Five other patients were also disheartened feeling the chair exercises had not increased in intensity sufficiently nor challenged them enough even at level seven. Caregivers confirmed how the combined manual information and advice from the facilitator increased their confidence to gauge and support more appropriate levels of exercise for the patient.
The negative impact of HF on participants' normal lifestyle and abilities could be profound as illustrated by one man who loved gardening. Others only completed specific sections, most commonly the weight and symptoms section. For those who found the tracker helpful, this daily symptom assessment was translated into long term behaviour change extending beyond the REACH-HF intervention.
Proactive symptom monitoring also improved patients' abilities to communicate with doctors to allow prescribing of appropriate treatment.
In contrast, a few participants disliked the repetitiveness of the tracker, even suggesting that this at times became the focus of their interaction with the facilitator "Every time she would come out she would start to look back through the stuff but she would go right to the front of the manual, not the manual the chart you call it, and would go through preceding weeks that she'd already covered" [Patient Interview 7] Nearly all caregivers believed that monitoring and assessing the physical and mental health of the patient was the most important but also a very difficult aspect of their role.
Identifying signs and symptoms, deciding on their seriousness, and whether they related to HF or another condition then initiating appropriate action was challenging. As one wife described "I suppose his breathing and I know like he's been quite concerned about sort of circulation in his legs. I don't even know if that's connected to the heart failure or if that's something else, because he has got quite a few health problems." [Caregiver Interview

18]
Proximity to the patients and frequency of contact also influenced caregivers' perceptions of their engagement in REACH-HF. One caregiver despite living over 50 miles away provided an excellent example of monitoring her relative's physical and emotional state and adopting a 'virtual caregivers role' providing encouragement and emotional support through mobile technology using texts or more often FaceTime. She described the benefit of how "you can see it on him, to be honest. Sometimes he doesn't look too good… his breathing isn't good and he looks kind of grey… I suppose FaceTime is a different way of doing things and…. It's lets you be involved." [Caregiver Interview 18] Although using technology allowed her to assess his appearance, body language and suggest interventions in a similar way to face-to-face caregivers, what differed was her limited ability to provide physical assistance. The patient could also choose not to converse over visual media (especially if they are feeling particularly unwell). This obviously undermines the virtual caregiver's ability to assess the situation, and can cause them stress, worry and sleepless nights Unique Caregiver views and experiences Within this study there was a strong reluctance to be identified as 'caregivers', even when the 'caregiver' assisted the patient in activities such as washing and dressing. Caregivers regarded their caring role as 'fluid'. Most described providing minimal physical assistance on a day-to-day basis with increased help when away from home or during episodes of patient's illness. Caregivers also highlighted how balancing competing demands on their time (e.g., caring roles for other family members), or their own health status, could affect the support they were able to give. Despite these challenges, caregivers did report examples of acting as an enabler and motivator especially in encouraging patients to exercise, often by doing this together.
Use of the friends and family resource also varied. Some read this from cover to cover, then used it as a reference (to review the meaning of symptoms or reinforce the facilitator's advice by referring the patient to that section of the manual) and a guide to action. However, the majority were intermittent engagers often reading the information explaining HF or quickly glancing through it. Caregivers with no or intermittent engagement believed that the manual was primarily for the patient.

Discussion
This process evaluation provides an understanding of how the REACH-HF intervention operated in practice for patients with HFpEF and their caregivers. We observed that the intervention was largely successfully delivered and well received by participants. This study also highlights the genuine need for support in a population often excluded from many HF and CR services [6]. The home-based nature of the REACH-HF intervention also offers an opportunity to overcome the current challenge of suboptimal uptake of CR for HF [1,11].
Although, fidelity analysis found the interventions to be delivered adequately over the majority of its components, we also found there was scope for improvement. This was particularly the case in relation to engagement with caregivers, a finding also reported with HFrEF patients [17]. Caregivers themselves believed that REACH-HF was for the patient and not for them, suggesting a more proactive strategy for caregiver involvement may be required in future intervention delivery [17].
The need to understand about, and know how to manage their HF, reinforces earlier research in HFrEF patients [18,19] and caregivers [20,21]. Addressing participants' needs for clarity in relation to their diagnosis and the implications of this condition can increase understanding, alleviate patient and caregivers' anxiety and allow them to accept and accommodate HF in their lives. Greater knowledge and confidence in caregivers, as shown in this study, can also enable more appropriate monitoring and support confirming previously reported findings of optimised symptom management and self-care behaviour [21,22]. Some participants valued monitoring as a measure of their progress and stability, others seeing this as a chore which has also been reported in the use of symptom monitoring diaries [23].
Increasing patient's and caregiver's knowledge of HF, enabling them to link symptoms e.g.
breathlessness to increased weight allowed earlier detection and prevention of deterioration, is a core element in HF care provision [24,25]. This was achieved through information provided in the manual and explanations by facilitators. The importance of feeling that someone listened and cared, acknowledged emotions, illness beliefs, anxiety and depression, yet provided feedback and encouragement to improve self-efficacy was highlighted by the participants. These are critical issues in empowering patients to selfmonitor and manage to optimise outcomes to improve health-related quality of life [26].
Applying goal setting and pacing techniques to break down tasks (e.g., shopping, housework and gardening) into manageable elements also allowed more proactive selfmanagement of their condition.
The analysis from the current study suggests that HFpEF patients and their caregivers have a number of unmet needs and that the REACH-HF intervention may offer a possible solution to address this gap. The role of facilitators in implementing the REACH-HF programme is crucial. The facilitator had an important role in the prescription and support of exercise and other lifestyle change during the programme and enabled many participants to maintain exercise and dietary changes beyond completion of the programme, reflecting previous work [20]. Caregivers generally were more able to recall and describe the interactions between the facilitator and the patient or themselves better than the content of the REACH-HF manual. By employing counselling and coaching skills, listening to patients concerns, providing reassurance, reframing problems, helping them to adapt to any limitations, and motivating the patient and at times the caregivers themselves to take exercise, the facilitator had assisted the both patients and caregiver in their caring role.

Strengths and Limitations
This study has benefited from a mixed methods approach which enabled greater understanding of the issues. We successfully recruited the target number of HFpEF patients and strengthened the sample by including their respective care givers, who are seldom included in HF research studies [27]. We tested methods and procedures to introduce and assess the fidelity of REACH-HF, a rehabilitation intervention, to HFpEF patients and their caregivers, a group with limited access to HF and rehabilitation services. We assessed adherence to intervention protocols, the quality of consultation interactions and explored HFpEF patients' and caregivers' experiences of this. Qualitative data also captured some examples of good practice in education, engagement and support of HFpEF patients and their caregivers. Completing fidelity analysis may be a useful tool for self-reflection and improving professional practice for specialist nurses. We believe this process evaluation enhanced the reliability of the results and ..are in keeping with the findings of the process evaluation conducted alongside our multicentre RCT in patients with HFrEF [17]. Our learning from this study will inform future optimisation of the interventions [28,29].
However, this study also had limitations. Our translation of complex interpersonal interactions into numerical scores within the fidelity analysis was unable to fully illustrate some of the excellent examples of good practice. Facilitators often demonstrated high levels of skill and competence in providing tailored educational and psychological support, enabling patients to reframe negative thoughts, engage in appropriate exercise and participate in self-management. Capturing qualitative data highlighted many unmet needs in both HFpEF patients and their caregivers, a group currently excluded from HF services, and in the main found the respective components of the intervention (the manual, exercise training, and facilitation) to be well received by patients and, when involved, their caregivers. The sample size within this study was small and the characteristics of the participants (predominantly of white ethnic origin) and single setting limit the potential generalisability. Whilst the assessment of the fidelity of interventions by independent scorers enhanced confidence in the results, their varied professional backgrounds (nurse researcher and social scientist) may have influenced interpretations of the fidelity scoring.

Conclusions
This process evaluation provides important evidence supporting the feasibility and acceptability of delivering the REACH-HF intervention that has the potential to address some key unmet needs in HFpEF patients and their caregivers. One of the most important intervention components identified by this study was the role of the healthcare facilitator, who acted as an educator, a source of support and reassurance, as well as a motivator and enabler. The facilitators helped to reframe participants thinking to enable engagement in activity, symptom monitoring and self-management of their HF through realistic goal setting and pacing. The study also identified how involving caregivers was at times challenging and a more proactive strategy may be required to optimise this part of the intervention in future applications and clinical trials.