Study participants
The flow of study participants is shown in Figure 1. Between April 2015 and June 2016, 50 patients were randomised (intervention group, n=25; control group, n=25). The characteristics of the 15 patients and six caregivers who participated in the process evaluation are summarised in Table 1. Patients had a mean (± SD) age of 71 (± 10.7) years with a similar proportion of men and and women. Caregivers were typically a spouse or partner, younger (mean age 66 ± 10.6 years) and female. The process evaluation sample was representative of the trial intervention group [14].
Table 1: Baseline characteristics of HFpEF patients and their caregivers
|
HFpEF patients, n = 15
|
Caregivers, n = 61
|
Gender (female), n (%)
|
9 (60)
|
5 (83)
|
Age (years), mean (SD)
|
70.4 (10.6)
|
62.8 (10.7)
|
Relationship to patient, n (%)
Spouse/partner
Sibling
Son/daughter
|
|
3 (50)
2 (33)
1 (17)
|
Number of comorbidities, n (%)
0
1
2
|
2 (13)
12 (80)
1 (7)
|
|
HADS depression, n (%)
< 9
9-10
> 10
|
11 (73)
1 (7)
3 (20)
|
5 (83)
1 (17)
0 (0)
|
HADS anxiety, n (%)
< 9
9-10
> 10
|
9 (60)
2 (13)
4 (27)
|
2 (33)
2 (33)
2 (33)
|
Living alone, n (%)
|
5 (33)
|
|
- Data was available for 6 of the 7 caregivers;
SD standard deviation; HADS: Hosptial Anxiety and Depression Scale
Fidelity of intervention delivery
The six patients and caregivers included in the fidelity analysis contributed a total of 41 facilitator interactions. Of these, 34 were face-to-face contacts (mean duration: 63 minutes, range 10 to 154 minutes) and seven were telephone contacts (mean duration: 6 minutes, range 5 to 13 minutes). All patient/caregiver and facilitator face-to-face contacts were recorded with one exception due to audiotape malfunction. In contrast, not all telephone interactions were recorded and, in those which were, the recording quality of the patient’s conversation was poor. The content of the telephone interactions identified that they were often used to briefly ‘check in’ with participants and confirm their next scheduled face-to-face appointment, rather than assess goal setting or discuss health issues.
The audio-recording analysis of the interactions highlighted some excellent examples of the skilled facilitation using active listening skills. Facilitators listened and responded to concerns, addressed health issues, corrected misconceptions, and provided education, reassurance, and support. They facilitated goal setting and pacing within daily living and behaviour change by enabling and empowering participants to better manage their condition and engage in the REACH-HF intervention. They also instilled confidence in patients and caregivers through supportive interactions. In addition to many examples of excellent practice, this data also highlighted areas for improvement, e.g. when important cues were missed by facilitators, the absence of relatives in the interactions, and lack of caregiver interaction (even when the caregiver was physically present).
Semi-structured qualitative interviews
All 15 patients and seven caregivers completed the interviews with a mean duration of 42 minutes (range 7 to 70 minutes), the majority undertaken either in participant’s homes (21) or one by telephone. Three overarching themes and 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.
Reaction to diagnosis
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 as 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 enabling them to explain their symptoms and condition to others. The majority felt the description of HF in the REACH-HF manual, combined with the facilitator’s explanation, aided their understanding of HF and equipped 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 ‘death sentence’), requiring constant surveillance and 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.
Theme 2: Emotional consequences of HFpEF
Loss of identity
Some participants reported restricted abilities and men especially struggled to adapt to these limitations expressing a strong sense of loss of identity. For example, one participant repeatedly expressed:
“I’m not the man I used to be.” [Patient interview 7]
and another that:
“Everything‘s been taken away.” [Patient Interview 13]
They often compared their lives now to those before their illness, e.g. related to their occupational role or physical fitness. They were frustrated by how others (e.g. family, health care staff) now perceived them as individuals struggling with the constraints of their condition. Some yearned for the opportunity to demonstrate their more positive ‘former selves’ e.g., confident people with a purpose in life. One participant even expressed it may be better for himself and his family if he were dead:
“I don’t want to be here, and everybody says: That’s not fair to your wife or your kids. Wait a minute, I says, Really? This is unfair to my wife and my kids. My wife deserves to be taken away for the weekend. I can’t do that.” [Patient interview 13]
Caregivers confirmed this loss of social and professional roles in HF patients and acknowledged their personal challenges in managing such strong negative emotion. Caregivers highlighted the importance of regaining ‘a sense of purpose’.
“… because I think he feels worthless. Sometimes I think he wishes he wasn’t here.” [Caregiver interview 13b]
Instead, when patients felt useful (e.g. helping other people) or socialised and interacted with others, it lifted them emotionally and motivated them to care for themselves.
Recognising and responding to emotion
Patients and caregivers reported anger or low mood often related to their feelings of frustration associated with the limitations that HF imposed on their lifestyles. For six patients, the manual helped them to recognise their altered mood. Working with the facilitators enabled better management of these emotions, sometimes drawing on existing strategies, e.g. mindfulness or using new techniques, such as relaxation. Enabling patients to understand that that these feelings were ‘normal’ under the circumstances, allowed caregivers to support the patient’s psychological adjustment to their HF. Caregivers suggested that the intervention had reduced anxiety and improved mood, particularly in patients with elevated HADS scores. As one caregiver described:
“I just feel once he started to understand more about heart failure, with the manual, that yes, he sort of - I don't know, sort of maybe accepted it more… I think sometimes he sort of panics, thinking oh you know, should I be feeling this way? Whereas having the manual has, I think, sort of made him realise yes, this is normal for me to feel like this and be like this.” [Caregiver Interview 18]
Caregivers also reported how the intervention positively addressed their own personal anxieties, thus allowing them to be more supportive. As one spouse said:
“someone like myself who needs the confidence to know how to understand heart failure, to know how be less anxious... because your stress goes on to the patient … and can make them more anxious. So, if you understand maybe a little bit more about it. … you can sort of be more of a support. I think that’s what I’m trying to say.” [Caregiver Interview 20]
Theme 3: Response to REACH-HF Intervention
Engagement with the REACH-HF Intervention
While all participants engaged with the intervention at some level, this varied across the components. Participants confirmed that the REACH-HF manual provided information and reassurance: ‘offering something for everyone’. In combination with the Progress Tracker, this aided symptom monitoring and supported self-management. Patients and caregivers accounts again reinforced their need to understand how to manage HF by knowing what to look for in case of deterioration and what to do in an emergency. Through improved understanding, caregivers felt more confident in supporting the patients.
Most patients said that they followed the exercise recommendations within the manual and were able to progress satisfactorily through the chair-based exercise programme (delivered by DVD) as advised by the facilitator, either alone or together with their caregiver. A few patients needed guidance to prevent inappropriate rapid progression through the exercise levels. Facilitators proactively encouraged engagement in exercise, at times completing the chair or walking programme with resistant individuals. One participant, on the verge of giving up, described how the facilitator had supported him to identify and complete an alternative activity.
[She said] “No, if you can’t do that what do you love doing?” I says, “I love walking.”
She went, “Right, if you want to go out for a walk, let’s go out for a walk.”
[Patient Interview 13]
Such support provided participants with the knowledge and confidence to continue this themselves. Several caregivers who completed the chair exercise or walked with the patient, valued this opportunity for social interaction and felt better emotionally afterwards. Those with a positive perception of the exercises were more strongly motivated to maintain them and integrate this into their lives. The biggest barrier to exercise was concurrent illness (e.g. chest pain) which either delayed exercise initiation or progression and episodes of acute illness (e.g. chest infection) which affected six participants and resulted in them stopping exercise for several weeks then restarting at a reduced level. Of four patients with co-ordination and balance problems, two adapted by holding the back of chairs for balance and slowly progressing through the chair exercises. In contrast, the other two patients 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-based 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:
‘I had just a little bit of turf about that long and I dug it up and whether it was the bending up or down or just pushing the shovel in that made me very unwell for I think it was about a week to recover. That’s one of the things I’ve found now that if I push myself and overdo it it’s the aftereffects that last longer’ [Patient interview 7]
Again, facilitators helped patients to reframe their thinking, set more realistic goals and breakdown their activities to make them manageable through goal setting and pacing, which maintained a sense of achievement.
Changes in health-related behaviours
The majority (14 patients) reported some change in behaviour because of the programme. Changes included maintaining the exercise regime beyond completion of the programme (13 patients), continued symptom tracking/monitoring (eight patients), and dietary modifications (two patients). Patients who perceived immediate symptomatic benefits from the exercises were most likely to keep up their exercise regime. Others reported this had also improved their sleep patterns. Most patients claimed they knew about and followed healthy diets; two participants discussed the value of the healthy eating section. One described how involvement in REACH-HF motivated him to set new dietary goals which included healthier food shopping and more home cooking. By setting goals and applying pacing techniques this enabled him to complete his weekly shopping which had previously been a challenge.
Only two participants continued to engage in undesirable health behaviours such as smoking and consuming a high fat diet. They did not causally connect these behaviours to their heart disease or weight gain.
Caregivers often described facilitators as the primary motivation for behaviour change in patients and the manual was a useful resource to complement facilitator-patient interactions. Caregivers typically encouraged and supported patients to change their lifestyles, helping them manage symptoms and engage in activities, reinforcing the facilitator’s recommendations. Some also changed their own behaviours. For example, one spouse reported:
“[The facilitator] was very helpful for me in so many different ways. Helping me to understand heart failure…she encouraged me to go out walking… Just the reassurance that things were better, that there was somebody there that was willing to, erm, say, well, okay, you’re doing well. Even just the smallest amount of encouragement. And ‘my husband always felt better after [the facilitator] went away. Because she felt…almost like a little security blanket, if you want to say. That somebody was there, somebody was asking.” [Caregiver Interview 20]
Feeling that someone ‘cared’, listened, answered questions, and provided feedback and encouragement was important to participants.
Monitoring and symptom tracking
Use of the Progress Tracker to record weekly symptom monitoring and exercise progress was variable. Some showed no desire to complete this, expressing that
“Filling it all in…. that is a bit annoying you know what I mean” [Patient Interview 1]
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 spouse 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.