The impact of heart failure on patients and caregivers: A qualitative study

Background Heart failure is rising in prevalence but relatively little is known about the experiences and journey of patients and their caregivers. The goal of this paper is to present the symptom and symptom impact experiences of patients with heart failure and their caregivers. Methods This was a United States-based study wherein in-person focus groups were conducted. Groups were audio recorded, transcribed and a content-analysis approach was used to analyze the data. Results Ninety participants (64 patients and 26 caregivers) were included in the study. Most patients were female (52.0%) with mean age 59.3 ± 8 years; 55.6% were New York Heart Association Class II. The most commonly reported symptoms were shortness of breath (81.3%), fatigue/tiredness (76.6%), swelling of legs and ankles (57.8%), and trouble sleeping (50.0%). Patients reported reductions in social/family interactions (67.2%), dietary changes (64.1%), and difficulty walking and climbing stairs (56.3%) as the most common adverse disease impacts. Mental-health sequelae were noted as depression and sadness (43.8%), fear of dying (32.8%), and anxiety (32.8%). Caregivers (mean age 55.5 ± 11.2 years and 52.0% female) discussed 33 daily heart failure impacts, with the top three being reductions in social/family interactions (50.0%); being stressed, worried, and fearful (46.2%); and having to monitor their “patience” level (42.3%). Conclusions There are serious unmet needs in HF for both patients and caregivers. More research is needed to better characterize these needs and the impacts of HF along with the development and evaluation of disease management toolkits that can support patients and their caregivers.


Introduction
While past research has characterized the burden of HF on patients and caregivers, it is not without limitations, which motivated the current research. First, some studies were published 11-13 years ago [10,24]. Treatments for HF have advanced across that period, perhaps making these more dated studies less salient and informative in terms of the patient and caregiver journey. Second, some sample sizes have been quite small (fewer than 20 patient and/or caregiver participants [13,17,23,24]), which can limit their generalizability. Third, other past studies were conducted at single sites within a given country [15,17,22,24], which also contributes to generalizability issues. Fourth, two studies were literature reviews with articles dating up to 20 years ago [14,18]. Fifth, of the past qualitative studies, all were one-on-one interviews. While one-on-one interviews and focus groups each have inherent limitations, focus groups can often lead to more discerning discoveries because group interactions can yield more meaningful findings than individual interviews [25]. With these limitations and considerations in mind, we embarked on qualitative discovery research with 64 HF patients and 24 caregivers of HF patients sampled in 2017 and 2018 in three US cities (in different geographical regions) with an aim to cross-validate past studies and contribute new insights.

Study design and sampling
This was an observational, cross-sectional, qualitative, focus group study in the US wherein 19 in-person focus groups were conducted with 64 patients with HF and 26 caregivers. The study independently recruited patients and caregivers. In this article, the term "caregiver" was used to define anyone who cares-unpaid-for a friend or a family member living with HF.
Patients included in the study had to be at least 45 years old at the time of screening and self-reported the following: a diagnosis of HF, at least New York Heart Association (NYHA) class II, and taking at least one HF prescription medication in the last six months. Caregivers were eligible if they were at least 21 years old, a relative of any HF patient (not necessarily participating in the focus groups) with at least NYHA class II status who is not participating in the study, and a self-report of spending at least eight hours a week caring for the HF patient. All participants were recruited using market-research vendors across four US locations: Beverly Hills, CA; Skokie, IL; Boston, MA; and Philadelphia, PA. A standardized recruitment script was used by the vendors to identify potential participants from their proprietary databases. The sample was selected to represent as diverse a participant mix as possible regarding gender, age, socioeconomic status, and ethnicity. Male and female sessions were conducted separately as were patient and caregiver sessions. All procedures and patient-facing materials were approved by Ethical & Independent Review Services institutional review board (IRB), which is an independent ethics committee, before study initiation. All participants were consented verbally and in writing. The identification number for this study is 17191.
The patient and caregiver focus groups were conducted using semi-structured discussion guides. The patient guide was carefully designed to elicit physical and emotional sequelae, selfmanagement, medication adherence, and manifestations of worsening and improvement in overall health status to understand participants' symptom experience, impacts on day-to-day functioning, and solutions and resources that could facilitate the HF journey. For the caregiver groups, the guide was designed to understand length of experience, roles and responsibilities, extent of educational resources and social support, and facilitators and barriers to caregiving. Both discussion guides were reviewed by two HF patient advocates who participated in the study to provide feedback on the focus group questions. Table 1 gives illustrative questions that were used in the focus group guides. All focus group sessions were audio-and videorecorded (with participants' permission) and lasted approximately 90 minutes.
Following written informed consent, focus groups were conducted by one of the researchers (CAM) who used probing and non-verbal techniques to elicit responses from participants following the semi-structured interview guide. All participants also completed a self-reported sociodemographic and clinical questionnaire. Recognizing the wealth of literature around HF symptoms and impacts, two small (8.5x11-inch) posters were developed that included the cardinal HF symptoms and impacts (S1 Appendix). This was utilized to cue the participants and act as a steppingstone to other discussion topics.

Qualitative data analysis
All audio recordings of the focus group discussions were professionally transcribed. Upon receipt of each transcript, one researcher (NT) performed quality checks. The goal of this step was to correct any transcription errors and remove any personal health information found within the transcripts. A content-analysis approach was used to analyze the focus group discussion data (based on notes, transcripts, and audio recordings). All analyses were performed using an analysis software program (ATLAS.ti version 7.5.2). A coding dictionary was developed prior to qualitatively analyzing the transcripts to capture the symptoms and impacts elicited in the sessions. The coding dictionary was revised in vivo to include codes for new concepts. Once all transcript coding was complete, all codes were thoroughly reviewed by a second team member to ensure it was performed in an accurate and consistent manner. The qualitative output included the text captured by the coding process for each code and the participant quotes organized by HF symptoms and impacts from the perspective of patients and caregivers interviewed.

Quantitative data analysis
A DataFax database for all quantitative data was developed, tested, and validated prior to data entry. DataFax is a 21 Code of Federal Regulations (CFR) Part 11-compliant, direct fax-tocomputer data management system that relies on optical character recognition (OCR) software for collecting study data from case report forms. The quantitative data entered by the OCR software was reviewed by two independent reviewers to ensure accuracy. Descriptive statistics (number, mean, standard deviation [SD], and frequency) were presented for the sociodemographic and clinical form items.
[Participant name 1, FG#1]: "the concomitant shortness of breath, that's the #1 thing. It really plays havoc with a whole lot of other things. So the second one is the speed at which I get fatigued. And the length of time it takes to recover from being fatigued. And that is physical fatigue that-like [participant name 3] mentioned, it also really wipes out your ability to, like, stay focused, or even care to focus." Table 5 provides a summary of the spontaneous and probed HF impacts from the patient perspective. A total of 47 day-to-day HF impacts were elicited from the patients. The top-three impacts were changes/reductions in social/family interactions (n = 43; 67.2%), dietary changes and restrictions (n = 41; 64.1%), and difficulty walking and climbing stairs (n = 36; 56.3%). Several mental-health sequelae were noted as day-to-day impacts including depression and sadness (n = 28; 43.8%), fear of dying (n = 21; 32.8%), anxiety (n = 21, 32.8%), and difficulty concentrating (n = 10; 15.7%). Other common physical impacts were: less exercise or low endurance for exercise (n = 31, 48.4%), being able to engage in recreational activities and hobbies (n = 28; 43.8%), difficulty performing work or job responsibilities (n = 17; 26.6%) or household chores (n = 15; 24.4%), difficulty lifting or carrying items (n = 13; 20.3%), needing frequent rests (n = 13; 20.3%), and frequent urination (n = 12; 18.8%). Eleven patients (17.2%) expressed that they disliked taking their medications predominantly due to side effects such as frequent urination.
[participant name 1, FG#1]: "Life's a chore a lot of the time. To go to the store is a chore. To go to dinner with friends is a chore. A lot of times, to be able to go out and fiddle around in my garden is a chore. To do the things that used to be able to give me joy are now chores." Caregivers Table 6 provides the demographic characteristics of 25 caregiver participants. A total of 26 caregivers were interviewed, but one participant did not fill out the sociodemographic form. Caregivers ranged in age from 33 to 71 years, with most identifying as non-Hispanic (n = 23, 92.0%), White (n = 19, 76.0%), and female (n = 13, 52.0%). The type of relationship to the HF patient included spouse/partner, child, sibling, or other relative; more than half (56.0%) of the caregivers lived with the HF patient. Caregivers were well educated with almost all (96.0%) reporting some college or higher. Table 7 provides a summary of the spontaneous and probed HF impacts and consequences from the caregiver perspective. A total of 33 day-to-day HF impacts were elicited from caregivers. The top impacts (greater than 20% endorsement) were changes/reductions in social/family interactions (n = 13; 50.0%); being stressed, worried, and fearful (n = 12; 46.2%) and having to monitor their "patience" level (n = 11; 42.3%). Eleven caregivers (42.3%) mentioned that they used vacation time for caregiving, made less money if they called off work, transitioned to part-time work, or retired early to meet the responsibilities of caring for their patient. Caregivers often expressed that they had difficulty performing work or job responsibilities or regular daily activities (n = 11; 42.3% negative/suboptimal changes in recreational activities and hobbies (n = 10; 38.5%); being frustrated (n = 9; 34.6%); physical consequences of being tired or exhausted (n = 8; 30.8%); sacrificing sleep, having insomnia, or trouble sleeping (n = 8; 30.8%); depression (n = 7; 26.9%); and feeling one is being taken for granted or feeling unappreciated (n = 6; 24.0%). Two caregivers (7.7%) expressed that their caregivee's had "slowed down" because of HF, often needing frequent rests and not being as agile as they used to be with respect to their physical abilities. Three caregivers (18.8%) expressed that their patient often fell off the furniture because of weakness they experience.
[003-202]: "Because he used to walk around the house with no issues. Now he is a little bit slow and he is feeling vulnerable in case he is at home at the house by himself, and he may have a fall and, uh, things like that." Below are some illustrative quotes that reflect caregiver impacts.

Discussion
Living with and managing HF is a "shared experience" [14] and is demanding and arduous "work" [16,24] for patients and their caregivers. The HF journey adversely impacts patient and caregiver physical, mental, and social well-being and can bring about fear, uncertainty, depression, anxiety, and isolation. Understanding and addressing the totality of these experiences is a first step to improving patients' and caregivers' symptom ramifications. This qualitative study confirmed previous research about the cardinal HF symptoms from the patient perspective and their daily impacts on patients with HF. These HF cardinal symptoms (from the patient perspective) were shortness of breath, tiredness and fatigue, edema, and difficulty sleeping [4,[26][27][28][29][30][31][32][33][34][35][36][37]. Because the physical symptoms of HF can be so debilitating and incapacitating, several patient-preference studies have shown that HF patients value symptom stabilization or improvement (especially with respect to dyspnea, fatigue, and physical functioning) over outcomes such as hospitalization and increased risk of mortality [8,9,[38][39][40]. In a qualitative, focus group study, Kraai and colleagues [41] reported that decreased symptoms, physical functioning, prevention of hospital readmissions, and living a normal life were the HF treatment goals most important to patients; none of the participants mentioned improved survival as a treatment goal. This research also corroborated the mental-health sequelae associated with HF reported by others including depression [5,7,29,32,34,42,43] and anxiety [29,33,34]. Patients often struggle with their new identity as a person with HF as well as its barriers on daily and normal activities that were once done without forethought and planning.
The findings of the current qualitative study further support the results of other studies demonstrating that the frequency and severity of HF-related symptoms (i.e., shortness of breath, fatigue, edema, etc.) impact physical, emotional and social functioning and well-being and results in significantly impaired HRQoL [4,28,44,45]. This qualitative research with 64 patients and 26 caregivers provides contemporary information on these impacts based on the perspective of the patients themselves and helps to provide a more real-life interpretation of these impacts of symptoms on functioning and well-being. This qualitative research poignantly described the lived experiences of being a caregiver of patients with HF. Caregivers play a key and meaningful role in their caregivee's HF self-care and HF health outcomes [20]. However, most of the caregivers interviewed in this study often felt they were on their own, left to their own devices, and lacked support and training for their new roles. Many of the caregivers interviewed in this study had to make significant changes to their daily life and routine including early retirement or reduced employment hours. Many also reported a significant amount of stress, and often social and emotional isolation, associated with caregiving for a patient with HF. Caregivers often had to assume additional daily roles and responsibilities due to their caregivee's functional and psychosocial limitations. Many caregivers experienced caregiver "overload" and experienced their own recurring problems with fragile emotional and physical health, excessive stress, and problems with sleep. Intermittent periods of resentment and feeling unappreciated/taken for granted (e.g., being a forced volunteer [13] and an unsung hero [17]) were common among the caregivers studied herein.
This study provides evidence of patient and caregiver unmet needs in HF which are poorly understood by clinicians and vastly underserved by the healthcare system. These unmet needs require interventions that not only meet the diverse cultural needs of patients and their caregivers but also incorporates individual preferences for optimizing health outcomes that mean the most to patients and caregivers.

Limitations
This qualitative study has several limitations. First, the mean duration of living with HF was 8.9 years. By the virtue of surviving this time, these patients may have generally had the opportunity to find a new equilibrium with their disease and its impact on their caregivers. Thus, these findings may not be extended to patients living with HF for fewer years. Next, small sample sizes-which can limit generalizability and external validity-are often a characteristic of qualitative research as was the case in this study. However, our sample of 64 patients and 26 caregivers was considerably larger than that of past research. The sample of interviewed patients and caregivers was fairly well educated, relatively young, underrepresented participants from Hispanic origin and resided in metropolitan cities It is unknown whether the burden and impacts reported herein would have been exacerbated or attenuated among more vulnerable HF patients and their caregivers. The key phenotypes of heart failure (i.e., HF with preserved vs. reduced ejection fraction) were not distinguished in sampling. Our sample of patients and caregivers were not paired or matched as was the case with past research. No qualitative subgroup analyses were conducted (e.g., by gender or age). Finally, 56.0% of the patients self-reported NYHA class II, 30.0% self-reported class III, and 13.0% self-reported class IV. It is unknown if the symptoms and impacts revealed herein would have been intensified if more symptomatic patients and their caregivers were sampled.

Conclusions
In conclusion, living with HF is a shared-and often demanding-journey between patients and their caregivers. Patients experience many distressing and burdensome HF symptoms and feel they have a detrimental and deleterious impact on their daily functioning and well-being. Many caregivers are overloaded and stressed and suffer from harmful, negative impacts on their physical and emotional health. The direct costs of HF only take into consideration objective metrics such as healthcare utilization and expenditures. Even measures of indirect costs, while slightly more patient-and caregiver-centered, do not account for or incorporate the distressing and disruptive deficits in functioning and well-being that patients and caregivers experience. As shown by this and other research, the magnitude of patient and caregiver unmet need is palpable. More systematic research is needed to better characterize and understand unmet need at the patient, caregiver, and societal level. We advocate for making HF a much higher priority-perhaps akin to the oncology patient-centered medical homes-with quality metrics and policy changes that can help ameliorate the daily suffering and broad societal impact that is currently vastly underestimated and undertreated.