Improving Self-Care of Informal Caregivers of Adults With Heart Failure
Phase: PHASE2
Conditions: Heart Failure
Sponsor: University of Pennsylvania

Informal caregiving is demanding and stressful. This stress may exceed the caregiver’s ability to adapt, and 
many eventually become care recipients themselves as years of stress and deferred self-care put them at 
increased risk for illness. Self-care refers to the behaviors undertaken to maintain health and manage illness. 
Engaging in self-care may improve health status, defined as physical functioning and mental well-being. 
Caregivers of adults with heart failure (HF) are an understudied group. HF is extremely common. Most HF 
patients remain in the community through the end of their lives, depending on informal caregivers to assist 
them. The trajectory of illness in HF is highly variable, which limits the use of palliative care and respite 
services. As a consequence, HF caregivers report significant stress and poor self-care. Health coaching, a 
support intervention, can improve self-care in patients, but studies evaluating HF caregivers are limited, as are 
studies of the cost-effectiveness of support interventions for caregivers. Even less is known about the effect of 
caregiver support interventions on HF patient outcomes. Caregiving duties often confine caregivers to the 
home and many are unable to attend in-person sessions, so we have developed and pilot tested a virtual 
support intervention (ViCCY [“Vicky”] – Virtual Caregiver Coach for You), that we propose to evaluate among 
HF caregivers. Using a randomized controlled trial (RCT) design, we will enroll informal HF caregivers with 
poor self-care (Health Self-Care Neglect scale score ≥2), randomizing them 1:1 to an intervention or control 
group. Both groups will receive standard care augmented with Health Information (HI) delivered through the 
Internet, but the ViCCY caregiver group will also receive 10 front-loaded coaching support sessions tailored to 
individual issues. The control group will have access to the same HI resources over the same interval, using 
the same Internet program, but without coaching support. At baseline and 3, 6, 9, and 12 months, we will 
collect self-reported data on self-care, stress, coping, and health status. At 6 months, we will compare ViCCY 
to HI alone to assess intervention efficacy using intent-to-treat analysis. Our pilot data suggest that addition of 
support provided by the health coach will make ViCCY more efficacious than HI alone. A sample of 250 
caregivers (125/arm) will provide >90% power to detect significant differences between the groups on the 
primary outcome of self-care (Aim 1). We will collect quality adjusted life years (QALYs) and health care 
resource use in caregivers over 12 months to assess cost-effectiveness of ViCCY (Aim 2). To explore the effect 
of caregiver outcomes on HF patients’ outcomes (hospitalization rates, hospital days, mortality rates, QALYs) 
over a 12-month period (Aim 3) and knowing that not all HF patients will participate, we will consent a 
subgroup of the HF patients cared for by these caregivers (at least 40 dyads). If shown to be efficacious and 
cost-effective, our virtual health coaching intervention can easily scaled to support millions of caregivers 
worldwide. This application addresses the NINR strategic plan and is directly responsive to PA-18-150.  
 
 
Contact PD/PI: RIEGEL, BARBARA J
Project Summary/Abstract                                                                                      
Page 6

SPECIFIC AIMS 
 
Informal caregivers have been called the “hidden victim” of illness.1 Caregiving is demanding and 
stressful for those who provide extraordinary, uncompensated care for loved ones, often daily for months and 
years.2 This stress may exceed the caregiver’s ability to adapt,3 and many eventually become care recipients 
themselves as years of stress and deferred self-care put them at increased risk for illness.4-8 Self-care refers to 
those behaviors a person undertakes to maintain health and manage illness.9 Engaging in self-care may 
improve an individual’s health status,10 defined as physical functioning and mental well-being.  
 
Caregivers of adults with heart failure (HF) are an understudied group. HF is extremely common (12% of 
US adults after age 65).11 Most HF patients remain in the community through the end of their lives, depending 
on informal caregivers to assist them.12 The trajectory of illness in HF is highly variable, which limits the use of 
palliative care and respite services.13-15 As a consequence, caregivers of patients with HF (HF caregivers) 
report significant stress and poor self-care, 16-20 and there is a critical need to identify ways to improve self-care 
in HF caregivers. Without doing so, we risk losing these burdened caregivers to their own health issues. 
 
Support interventions can encourage self-care by helping caregivers to focus on values, solve problems, 
and transform their goals into action.21,22 We and others have shown that health coaching can improve self-
care and outcomes in patients,23-25 but studies of caregivers are limited, as are studies of the cost-
effectiveness of support interventions for caregivers.15,26,27 Even less is known about the effect of caregiver 
support on patient outcomes, although caregiver burden and stress have been shown to be associated with 
higher rates of hospitalization for patients with HF.28,29 Although caregiving duties often confine caregivers to 
the home and many are unable to attend in-person sessions,30 support interventions can be delivered by 
telephone31 and the Internet.24,32,33 Leveraging the growing availability and declining costs of – along with 
increasing receptivity of older adults to – technology,34 we have developed and pilot tested a virtual support 
intervention (ViCCY [“Vicky”] – Virtual Caregiver Coach for You), that we propose to evaluate in HF caregivers.  
 
Using a randomized controlled trial (RCT) design, we will enroll informal HF caregivers with poor self-care 
(Health Self-Care Neglect35 scale score ≥2), randomizing them 1:1 to an intervention or control group. Both 
groups will receive standard care augmented with Health Information (HI) delivered through the Internet, but 
the ViCCY caregiver group will also receive 10 front-loaded coaching support sessions tailored to individual 
issues. The control group will have access to the same HI resources over the same interval, using the same 
Internet program, but without coaching support. At baseline and 3, 6, 9, and 12 months, we will collect self-
reported data on self-care, stress, coping, and health status. At 6 months, we will compare the efficacy of 
ViCCY (HI plus coaching) to HI alone to assess intervention efficacy using intent-to-treat analysis. Our pilot 
data suggest that addition of support provided by the health coach will make ViCCY more efficacious than HI 
alone. A sample of 250 caregivers (125/arm) will provide >90% power to detect significant differences between 
the groups on the primary outcome of self-care (Aim 1). We will collect quality adjusted life years (QALYs) and 
health care resource use in caregivers over 12 months to assess cost-effectiveness of ViCCY (Aim 2). To 
explore the effect of caregiver outcomes on HF patients’ outcomes over a 12-month period (Aim 3) and 
knowing that not all HF patients will participate, we will consent a subgroup of the HF patients cared for by 
these caregivers (at least 40 dyads). We have the following Specific Aims: 
Aim 1: To compare the efficacy of ViCCY vs. HI alone in improving self-care. We hypothesize that, at 6 
months after enrollment, caregivers randomized to ViCCY vs. HI alone will have H1a: Improved self-care 
measured with the Health Self-Care Neglect scale35 (primary outcome); H1b: Less self-reported stress 
measured with the Perceived Stress Scale36 (secondary outcome); H1c: Better coping measured with the 
Ways of Coping Questionnaire, short form37,38(secondary outcome); and H1d: Better perceived mental 
and physical health status measured with the SF-3639(secondary outcome). 
Aim 2: To estimate the cost and cost-effectiveness of ViCCY. We hypothesize that, at 12 months after 
enrollment, caregivers randomized to ViCCY vs. HI alone will have H2a: Higher QALYs measured with 
the SF-6D (short form six-dimension) derived from the SF-3640 (secondary outcome); and H2b: Lower 
health care resource use (secondary outcome). 
Aim 3 (Exploratory): To explore the effect of caregiver outcomes on HF patient outcomes. We hypothesize 
that, at 12 months after enrollment, HF patients whose caregivers improve vs. not improve in self-care – 
regardless of group – will have H3a: Lower hospitalization rates; H3b: Fewer hospital days; H3c: Lower 
mortality rates; and H3d: Higher QALYs measured with the SF-6D.40 
If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily scaled to 
support millions of caregivers worldwide. This application addresses the NINR strategic plan and is directly 
responsive to PA-18-150.  
Contact PD/PI: RIEGEL, BARBARA J
Specific Aims                                                                                                 
Page 72

RESEARCH STRATEGY 
A. SIGNIFICANCE 
A.1. Informal caregivers are stressed and their self-care is poor. Informal caregivers carry the bulk of the 
responsibility for the care of ill, disabled, and elderly individuals.41 More than 42 million unpaid informal 
caregivers provide care to someone needing help because of a limitation in physical, mental, or cognitive 
functioning.42 As a group, informal caregivers have more stress,43,44 worse self-care,10,45-48 poorer health 
status,8,27,49,50 and higher mortality than non-caregivers.48,51-55 Caregivers often feel left alone to cope with 
problems, which exacerbates their stress.56 When stressed, caregivers are less vigilant and less motivated to 
engage in behaviors that will benefit themselves and their charges.57,58 In a study of 121 mainly female 
caregivers (mean age 61±13.4 years) of older family members, healthy self-care behaviors were lowest in 
those with high stress scores.59 In another study, after four years of follow-up, stressed caregivers were at 63% 
higher risk for mortality than non-caregiving controls.7 Together these studies illustrate the risk that informal 
care providers face when they defer self-care in response to the stress of caregiving.  
A.2. Informal caregivers of patients with heart failure (HF caregivers) are an understudied population. 
Although informal HF caregivers face many of the same issues as other caregivers, they also face unique 
challenges. HF caregivers are older than other caregivers (mean 55.7 vs 49.4 years; p < 0.001).60 Both the 
patients and their caregivers often have multiple comorbid illnesses, making caregiving complicated. The 
trajectory of HF is highly variable with a gradual decline in function, so the need for caregiving lasts longer than 
for other populations.61 Because of this unpredictability, neither palliative care to HF patients nor respite 
services to their caregivers are routinely offered.13,20,60,62,63 HF is associated with poor physical capacity, 
depression, behavior problems, and cognitive impairment.20,64-67 Caregivers report difficulty coping with these 
patient-symptoms,68 with the most stressful daily duties being providing emotional support, structuring and 
planning activities, and managing patient behavior and mood.69-71 Caregivers must supervise and monitor 
complex care regimens and coordinate frequent hospitalizations,72,73 the latter being so stressful that well-
being is lower in caregivers than in patients when HF patients are hospitalized.74  HF caregiving is expensive, 
incurring lost-wages and out-of-pocket expenses; in a study of end-stage HF patients, 23% of families had lost 
all or most of their savings by the time the patient died.75 These issues have a profound effect on caregivers’ 
lives.76,77 While caregivers of other populations often report satisfaction from caregiving, we see no evidence of 
caregiving satisfaction in HF caregivers. They are burdened, stressed, and poor in self-care.30,69,71,78 
A.3. Effective interventions are needed for HF caregivers. Few randomized controlled trials (RCTs) of 
interventions for HF caregivers have been published, 79 and of those, most have focused on improving HF 
caregiver burden, stress, or health status – not caregiver self-care.76,80,81 The most common interventions 
involved psychoeducation facilitated by a registered nurse (RN), supplemented with face-to-face follow-up 
sessions, home visits, telephone calls and/or virtual monitoring.82 Two studies focused on helping caregivers 
support patient self-care,81,83 but none focused on improving caregiver self-care. Few interventions reported 
a significant effect on one or more primary outcomes, and many were resource-intensive. For example, in a 
successful study in the Veterans Affairs system,84 team-managed, home-based primary care with a dedicated 
care manager, 24-hour contact for patients, prior approval of hospital readmissions, and team participation in 
discharge planning effectively reduced caregiver stress and improved health status, but patient care costs 
increased by 12% at 12 months due to increased staffing.84 In an unsuccessful approach, a trial of a 12-week 
chair exercise program for HF patients hypothesized to decrease stress in caregivers85 demonstrated 
increased caregiver stress after six months, perhaps due to increased caregiving demands. We believe that 
few interventions have been effective because of failure to include elements argued to be essential in 
caregiving interventions:86 1) a psychosocial rather than purely educational approach; 2) flexibility; 3) 
multidimensionality; and 4) sufficient intervention dose.  We developed ViCCY to address these elements. 
A.4. Internet-based virtual approaches can be used to support homebound caregivers. Successful 
implementation of potentially effective interventions is impeded when caregivers are homebound with 
caregiving duties.30,87 Yet, such isolated individuals may be among the most stressed caregivers in need of 
support.88,89 The home environment may be the best place to deliver an intervention, where distractions are 
predictable and privacy can be optimized.90 Home interventions are perceived as convenient, requiring less 
time commitment, travel costs, and waiting times; duration and timing of sessions can be flexible and 
accommodate caregiver preferences. Support is important to the success of psychosocial interventions,91 and 
virtual visual contact overcomes the challenges of lack of visual cues found in telephone-based interventions.92 
A 2015 review of virtual interventions to support family caregivers concluded that caregivers were satisfied and 
comfortable with virtual support.93 Another review of eight open-label trials and 16 RCTs concluded that 
Contact PD/PI: RIEGEL, BARBARA J
Research Strategy                                                                                             
Page 73

Internet-based interventions were effective in reducing caregiver stress and improving their well-being.94 
According to the 2015 US Census, 77% of the US population has broadband Internet access at home.95 Thus, 
live video-streaming is now possible for most people in the US at very low cost, making virtual support a 
potentially efficacious way to intervene with homebound caregivers.96  
A.5. Little is known about the cost-effectiveness of interventions for caregivers. Few cost-effectiveness 
analyses of support interventions have been performed in any chronically ill population. One review suggested 
that psychological therapies and psychosocial interventions were potentially cost-effective in people with 
dementia and their family caregivers.97 In a pragmatic RCT providing an 8-session coping intervention to family 
caregivers of people with dementia, the cost-effectiveness acceptability curve98 indicated >99% chance of being 
cost-effective in the short and longer term.99,100 There is also evidence that psychological therapies provided by 
Internet are cost-effective.101 No economic analyses of support interventions have been conducted in the HF 
population, but the annual cost associated with informal caregiving of patients with HF in the US was estimated 
at $3 billion in 2010.102 A Cochrane review examined the cost-effectiveness of home palliative care for adults 
with advanced illness, including HF, and their family caregivers,15 but found inconclusive evidence and 
recommended more study.15  
A.6. Dyadic processes influence outcomes. By definition, the caregiving relationship involves two people.103 
Several studies, including our own, have demonstrated that dyadic processes influence outcomes in both HF 
patients and their caregivers.78,80,104-108 The vast majority of these studies are descriptive, and no one has 
tested the influence of an intervention for caregivers on HF patient outcomes. The mechanism by which dyadic 
processes influence outcomes appears to be related to the quality of the relationship.105-108 Relationship quality 
influences burden,109 emotional distress,110 self-care behaviors,14,105 decision-making,111 and quality of life in 
both HF patients and caregivers.112 It is plausible that the relationship influences HF patient hospitalizations and 
mortality, but there is little evidence on this topic.28,29,113 Hospital readmissions within 30-days are especially high 
(20-25%) in HF patients,114 with almost two thirds of readmissions occurring within 15 days of discharge.115 Four 
of every five HF patients require hospitalization annually, and at least one-third are hospitalized repeatedly.116 
By 12 months, close to two-thirds of all HF patients have been readmitted.117 Hospitalizations are costly,118 and 
the annual total costs attributable to HF are so high119 that HF is the primary contributor to the US Medicare 
budget.120 More than half of those who develop HF die within five years of diagnosis.11  
A.7. Theoretical Framework. The proposed study is based on the Transactional Model of Stress and Coping 
(Figure 1).121 Stressful experiences such as caregiving demand – circumstances that give rise to real or 
perceived stress – are construed as person-environment transactions.121 Primary appraisal of demand involves 
assessment of its significance, which results in perceived burden. Secondary appraisal involves assessment of 
the resources available to cope with it. These appraisals lead to the coping effort.121 Without successful coping, 
self-care is poor, which 
decreases health status in 
caregivers. Our virtual support 
intervention [ViCCY (“Vicky”) – 
Virtual Caregiver Coach for You] 
addresses both appraisal and 
coping. Because stress does 
not affect all people equally, the 
intervention is tailored to 
individual appraisals and the 
factors most likely to influence 
demand and perceived 
burden.122 A key strength of the 
Transactional Model of Stress 
and Coping is its recognition 
that both individual and 
environmental variables 
respond to coping. See Section C.5 and Table 3 for details on how the theory is used in ViCCY. 
 
Scientific premise. This study builds on a body of evidence that is strong in describing stress in HF 
caregivers but weak in linking that stress to poor caregiver self-care. We have demonstrated in HF patients 
that self-care improves health status,123,124 but the relationship between self-care and health status has rarely 
been tested in HF caregivers.125 Health coaching has been shown to decrease perceived stress and improve 
Contact PD/PI: RIEGEL, BARBARA J
Research Strategy                                                                                             
Page 74

self-care and health status in other caregiver populations.126 Some of these studies have provided virtual 
support to homebound caregivers, and a few included older caregivers such as those we anticipate enrolling. 
However, very few studies have addressed the cost-effectiveness of interventions targeting informal 
caregivers. Furthermore, in addition to our primary aims, we will explore the impact of caregiver outcomes on 
HF patient outcomes. Although a growing body of research illustrates the influence of caregivers on patients 
and vice versa, (i.e., dyadic processes), very few intervention studies have explored the influence of the 
caregiver experience on patient outcomes.   
B.  INNOVATION 
Our proposed research is innovative for several reasons: 
1. We focus on a patient population (those with HF) with unique issues – e.g., symptom burden, impaired 
cognition, frequent hospitalizations, multimorbidity, and complex regimens – that increase caregiver 
demand, burden, and stress. While dementia caregivers face many of these issues,127 HF is different 
because palliative care is not offered routinely and respite services are rarely available.8,63,128 Without 
support services, these caregivers are extraordinarily stressed.20,129 High stress levels are associated with 
poor self-care.130 
2. Few studies of caregivers have focused on their self-care, and those studied other populations.  Most 
studies of HF emphasize the caregiver’s role in promoting HF patient self-care. The proposed study will 
provide a robust description of HF caregivers’ self-care and the manner in which it changes with 
intervention.  
3. We have developed a unique approach to health coaching that targets stress and self-care concurrently. 
ViCCY is potentially more powerful than interventions addressing either issue alone because self-care is 
lower in stressed populations and self-care can potentiate stress reduction approaches.131  
4. Using video technology to intervene with caregivers is not new but it is new in HF caregivers, who are a 
predominately older population. In spite of mounting evidence that older adults use technology regularly,132-
135 ageism persists and elders often are assumed to be unable to participate in research using 
technology.136,137 Our proposed study will be one of the first adequately powered trials of a virtual 
intervention for predominately older caregivers. If efficacious, this approach to the delivery of ViCCY can 
easily be deployed in any location and with other populations.  
5. Very few caregiver intervention studies have addressed cost-effectiveness. We include a formal cost 
effectiveness analysis in which caregivers are followed for 12 months.  
6. We explore the influence of caregiver outcomes on HF patient outcomes. A growing body of research 
illustrates the powerful influence of individuals in a dyad or couple on each other.106,108 But our study is 
unique and innovative in exploring the effect of a stress intervention for caregivers on outcomes in HF 
patients. Measuring QALYs in both caregivers and HF patients, we will be able to assess benefit in both. 
C.  APPROACH  
C.1. Research Team (see Biographical Sketches and Letters of Support for details). Our multidisciplinary 
team based at the University of Pennsylvania (Penn) is well positioned to complete the proposed study. Team 
members, most of whom have worked together for the past decade,138-145 bring unique but complementary 
perspectives that have informed all dimensions of the proposal: Barbara Riegel, PhD [Principal Investigator 
(PI)] HF, health coaching, motivational interviewing, caregivers, self-care]; Kathryn Bowles, PhD (Co-I) virtual 
technologies; Karen Hirschman, PhD (Co-I) interventions with older caregivers; Joyce Wald, DO (Co-I), heart 
failure; Norma B. Coe, PhD (Co-I) cost-effectiveness analysis; and Alexandra Hanlon, PhD (Co-I) biostatistics. 
Led by the PI, members will share responsibility for the conduct and integrity of the study. See Budget 
Narrative for specific responsibilities and contributions. 
C.2. Preliminary Studies. We developed our intervention in patients and have modified it for caregivers. In the 
first study, we refined our tailored health coaching intervention in 15 HF patients (mean age 60 ± 13.3 
years, 53% White, 60% female).146 The intervention, provided by an RN during an average of 3 ± 1.5 home 
visits over 3 months, focused on improving self-care. Motivational interviewing was used to elicit beliefs about 
the illness, personal goals, and self-efficacy. Reflective listening and empathy were used to provide support, 
decrease barriers and build skill in self-care. There was evidence of improvement in self-care in 80% of HF 
patients after receiving the intervention.146 In a second study, we tested health coaching vs. standard 
education in 100 HF patients (mean age 62 ± 12.8 years, 54% Black, 30% female) in an RCT.147 The 
intervention was provided by an RN in 1 in-person session and 2-3 telephone sessions over the first month 
after hospital discharge. At 3 months, more improvement in self-care was seen on the Self-Care of HF Index148 
Contact PD/PI: RIEGEL, BARBARA J
Research Strategy                                                                                             
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in the intervention group than the control group (19.7 ± 16.0 vs. 12.1 ± 18.3 improvement in standardized 
scores), a clinically and statistically significant difference after adjusting for confounding variables.149 The effect 
size was moderate (Cohen’s d = 0.44). Based on qualitative data collected in both studies, we learned that 
face-to-face sessions were more effective than telephone sessions, so we moved to using virtual technology.   
 
In preparation for this proposal, we conducted three pilot studies to adapt the intervention for 
caregivers. We first enrolled seven homebound female spouse caregivers of HF patients and interviewed 
them to identify stressors associated with caregiving. When we described the planned program, all were 
receptive to the electronic intervention and five of the seven women wanted to participate (“I need help 
desperately”).71 In the second pilot study, we tested four methods of distance communication – telephone, 
tablet (iPad) with video, laptop computer with video and a detachable webcam, and touchscreen videophone. 
The iPad facilitated privacy by allowing the caregiver to move to a private place while conversing and was 
preferred over other devices (“the iPad is just less threatening”). In the third study, we assessed feasibility of 
our planned methods and pilot-tested the ViCCY intervention.150 We enrolled four HF caregivers (white female 
spouses, mean age 66 ± 8.5 years) and gave each an iPad. Health coaches engaged each caregiver in 8 
support sessions over a 3-month period. Each session lasted approximately 1 hour. Data were collected at 
enrollment and three months later using most of the methods proposed below. Table 1 shows change in the 
main target variables. Technology problems were more common in coaches than caregivers and were quickly 
resolved with assistance. Together these pilot studies illustrate that caregivers are interested in participating, 
they are comfortable with the tablet technology, and our proposed methods are feasible. We learned to hire 
coaches adept with technology and to ensure that participants have a strong Internet connection.  
Table 1. Results from Pilot Study of Four Caregivers 
Baseline 
Score (SD) 
3-Month Follow-up 
Score (SD) 
Perceived Stress Scale (lower is better) 
20.7 (4.3) 
18.2 (0.96) 
Health Self-Care Neglect Scale (1-10 possible range, lower is better) 
3.2 (2.5) 
1.2 (1.2) 
SF-12 Health Status, Mental Component Score (higher is better)  
52.1 (9.1) 
55.6 (4.3) 
 
We have used virtual technology to deliver numerous interventions, including some of the early work 
using virtual approaches with older adults.138,140 In a field experiment funded by the Department of Commerce, 
we enrolled 174 elderly diabetic home health patients and provided a virtual intervention.151 Of those who 
refused, only 12% said the technology was too complicated, in spite of the fact that we used first-generation 
technology that was far more complicated than that proposed in this study – a virtual technology approach with 
tablets. Satisfaction with this delivery method was high. Our research staff has extensive experience in setting 
it up and instructing those having no knowledge of tablets to become proficient in its use.138,139,151-153  
C.3. Study Overview (Figure 2). We will use a RCT design to achieve robust and unbiased results, as 
detailed below. We will enroll 250 informal HF caregivers and, when possible, the HF patients for whom they 
care. After collecting baseline data, we will block randomize the caregivers 1:1 to the intervention or control 
group, stratifying randomization by caregiver sex and relationship to the patient (e.g., spouse, adult child) – 
factors known to influence caregiving burden, 
perceived stress, and receptivity to the 
intervention.8,154 We will provide tablet devices 
with wireless network access and connect 
caregivers in both conditions to the Internet so 
they can access the Internet site providing 
Health Information (HI) content, which will be 
the only content provided to caregivers in the 
control group. In addition to HI, the intervention 
group will receive 10 front-loaded sessions of 
ViCCY over 6 months. Assessments of self-care, perceived stress, coping, and health status will be conducted 
at baseline (after enrollment but prior to randomization) and by phone at 3, 6, 9 and 12 months. Using 
contrasts within a mixed-effect modeling framework, we will assess intervention efficacy at 6 months using 
intention-to-treat analysis. We chose to provide 10 health coaching sessions based on our pilot data and 
literature demonstrating that a shorter duration of health coaching is not routinely effective.21 We chose to 
assess the primary aim at 6 months based on prior psychosocial intervention studies,83,125,155 but we will 
assess outcomes at 3-month intervals based on this rationale: baseline (enrollment), to generate consistent 
profiles of all enrollees at a consistent point in time and prior to implementation of the new intervention; at 3-
months, very early effects, at 6-months, short-term effects; and at 12-months, the longer-term effects of ViCCY 
vs. HI. These 3-month intervals also will allow us to compare our results with others.156,157 We chose a 12-
Contact PD/PI: RIEGEL, BARBARA J
Research Strategy                                                                                             
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month follow-up interval for the cost-effectiveness analysis to allow for a full year of event accrual. We will pull 
resource use data from the electronic medical record (EMR) in 30 day increments and validated these data 
during routine follow-up calls with caregivers. We expect the proposed study to require 5 years for completion. 
C.4. Sample.  
C.4.a  Recruitment. We will enroll a consecutive sample of informal HF caregivers identified from the Penn 
Heart and Vascular Center (PHVC), the largest out-patient HF clinic in the Philadelphia region and a site at 
which the PI has established relationships and success in past recruitment of participants. In 2017, there were 
5344 HF patient visits (mean 445 visits per month). Of these, approximately 832 were new HF patients (mean 
69 new patients per month). In a prior study at this site, we enrolled 139 HF patients over 18 months; 84% of 
the screened and eligible patients enrolled.142 These 139 HF patients (45% female, 34% non-White, mostly 
Black) all lived at home with a family caregiver.   
 
If recruitment is slower than expected, we will identify caregivers visiting HF patients hospitalized at one 
of three University of Pennsylvania Health System (UPHS) sites, all of which use a single, integrated EMR with 
the level of financial data needed to address our cost-effectiveness aim. The Hospital of the University of 
Pennsylvania (HUP) has 789 licensed acute care beds. Between July 2016 and July 2017, HUP admitted 
1,859 HF patients. Presbyterian Medical Center (PMC) has 331 patient beds and admitted 1,621 HF patients in 
that year. Pennsylvania Hospital (PAH) has 496 licensed patient beds and admitted 716 HF patients that year. 
From these various sources, it is reasonable to project identifying 100 unique HF patients each month, most 
of whom will have caregivers. Based on our prior research,158-161 we anticipate that 90 will have caregivers and 
70% of these (63 caregivers) will be eligible, and 15% will enroll. Thus, we estimate enrolling 10 caregivers per 
month. We will require a minimum of 25 months for enrollment, and have conservatively allowed 30 months for 
enrollment and five years to complete the study.   
 
We will explore the relationship between HF caregiver and HF patient outcomes in a subgroup of at least 
40 caregiver-patient dyads; 40 dyads is sufficient to provide reliable parameter estimates. HF patient 
participants will be asked to provide informed consent to allow us to access their EMR to collect clinical 
information and track events and, in the case that patients receive care outside the Penn health system, for the 
caregiver to report on patient health care resource use. HF patients will not receive an intervention. If a 
caregiver agrees to participate but the HF patient does not, we will still enroll the caregiver. It is not possible (or 
desirable) to exclude caregivers of patients with comorbid illnesses that may increase caregiving demand 
given the high prevalence of comorbid conditions in HF patients.162-164 Thus, whenever possible we will also 
gather EMR data on patients’ comorbid illnesses using the Charlson Index categories of mild, moderate, or 
severe165 for use as a covariate in analyses.  
 
Based on our prior studies, we anticipate enrolling a diverse sample, with many in vulnerable racial, 
socio-economic, and geographically disadvantaged groups.160,166,167 Most caregivers will be spouses but some 
will be adult children. Although the sex distribution of HF patients is about equal,11 female HF patients are 
typically older. See Table 2 for caregiver inclusion and exclusion criteria. All willing HF patients cared for by an 
eligible and enrolled caregiver and capable of giving written informed consent will be eligible for inclusion.  
C.4.b. Screening, Enrollment, and Baseline Assessment. We will have a study Research Assistant (RA) on 
site during PHVC clinic hours and anticipate that many informal caregivers will be screened and enrolled 
during a HF patient clinic visit because meeting in person is anticipated to maximize enrollment.169 To obtain a 
consecutive sample we will seek a HIPAA waiver to screen the daily appointment schedule to identify every 
patient with a potentially eligible caregiver (e.g., living within 50 miles of the research office). Clinic staff will 
identify potential caregiver participants (e.g., speak English) and determine their interest in speaking with 
research staff about the study. If caregivers agree to speak with research staff, the RA will explain the study 
and screen the caregiver for inclusion and exclusion criteria with standardized testing (e.g., self-care) and 
interview (e.g., hearing). Fully eligible caregivers who provide informed consent (see Human Subjects) will 
complete the baseline assessment (Section C.9) before being randomized to study arm.  
Table 2. HF Caregiver Inclusion and Exclusion Criteria  
Inclusion Criteria 
1. Informal caregiver providing care at least 8 hours/week  
2. Reporting poor self-care on screening (Health Self-Care Neglect 
scale35 score ≥2 based on our pilot data) 
3. Able to complete the protocol, e.g., adequate vision and hearing, 
English speaking   
4. Living within 50 miles of the research office in case home visits 
are required for enrollment or Internet set-up 
Exclusion Criteria 
1. Cognitive impairment (Telephone Interview for Cognitive 
Status [TICS]168 < 25)  
2. Participation in another support RCT 
3. Untreated major psychiatric illness (Use of anti-anxiety/anti-
depressant medicines is acceptable and will be adjusted in 
analysis if group imbalance is identified.)  
4. Plans to move out of the area imminently 
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If we need to enroll from the hospital, an RA will be available in the hospital daily to give interested caregivers 
study information and conduct screening. We will obtain a HIPAA waiver to allow us to screen the daily 
admission log to identify every HF patient with a potentially eligible caregiver (e.g., living within 50 miles of the 
research office). Caregivers willing to speak with research staff will be screened as described above.  
If the caregiver is not able to complete the baseline assessment at the time of the clinic visit or during the 
patient’s hospitalization, a home visit will be scheduled to complete baseline data collection. After all baseline 
data are collection, the caregiver will be randomized to study arm. At that time, participants will be trained in 
tablet use and how to access the Health Information website. A research diary will be provided to aid tracking 
of health care resource use and cost.  
C.4.c  Consideration of Sex as a Biological Variable. In accordance with NIH guidance, we will include sex 
as a biological variable in study design (block randomization of men and women to each group), analyses, and 
reporting. We will report all primary and secondary outcomes separately by sex to enhance the rigor and 
transparency of our findings. We expect to enroll more female than male caregivers because most HF 
caregivers are female55 and support interventions are more appealing to women.170 Enrolling at least 50 men is 
a goal so that sex-related differences in intervention efficacy and outcomes can be identified. We will monitor 
enrollment weekly. If fewer than 15 male caregivers are enrolled in the first 3 months, we will conduct a focus 
group with male caregivers to identify specific elements that could be emphasized to make the intervention 
more attractive to them.171-175 
C.4.d. Randomization and Blinding. Block randomization will be used to achieve equal distribution of key 
variables in each condition. We will block randomize on caregiver sex (male/female) and relationship to patient 
(e.g., spouse) – factors shown to influence perceived caregiving burden176 and receptivity to intervention.177 
The randomization sequence will be generated a priori by a statistician independent of the study investigators 
using a randomly permuted blocks algorithm to ensure equal distribution of these variables in each study arm. 
The Project Manager will notify the study staff and participants of their group assignment (ViCCY or HI only) by 
telephone, email or message, as preferred by the individual. Although balance in sample size can be achieved 
with block randomization, the groups may not be fully comparable on other factors. Initial comparison of the 
groups will allow us to control for important covariates in the analyses.178 Investigators and all staff involved in 
collecting assessment data will be blinded to group assignment until after the data are locked. The RN 
providing the intervention and the caregiver participants will not be blinded.  All baseline data will be collected 
prior to randomizing. Timing of follow-up assessments will be based on day of randomization.  
C.5. Augmented Standard Care – Health Information (HI). Caregivers in both the intervention and control 
arms will receive augmented standard care content (HI) through the Internet. Standard care typically involves 
unstructured, intermittent outreach by nurses staffing physicians’ offices, but there is evidence that caregivers’ 
needs are not met with this approach.16,179 Augmented standard care (HI) in this study will be based on 
informational resources from the UK National Health Service (http://www.nhs.uk/pages/home.aspx). This rich 
Internet site (see Section C.7 for Internet availability) has educational pages on hundreds of conditions. The 
site offers self-help books and free self-help computer exercises designed for stress reduction and healthy self-
care. For instance, one module, Moodzone, teaches stress management skills with an interactive game, 
anxiety assessment, a downloadable relaxation audio, workbook, and feedback assessment. Using flashed 
diagrams and online exercises, Moodzone illustrates the relationship between thoughts and emotions and 
works through the process of dealing with stress. Relaxation and meditation techniques are described. Live 
Well provides excellent, updated content on diet, exercise, substance abuse, immunizations, etc. If a 
participant wishes to use the self-help books—equivalent in content—instead of or in addition to the online 
materials or in addition, we will provide those materials. Participating caregivers in both study arms will be 
encouraged to spend at least 30 minutes weekly using the Internet modules or books for six months and will 
receive monthly reminder cards by mail. We will track participant use of the website using Google Analytics, 
and those who are not using the website will be telephoned and reminded to do so. Those who choose to use 
books rather than the website will be asked to keep track of the number of book chapters reviewed each 
month. Use of the website or book chapters will be used as a measure of fidelity in both arms (see Section 
C.8). After six months, we will pick up all tablet devices (both groups) to minimize bleeding of the intervention 
into the follow-up period, and we will continue to track use of the website to identify if bleeding occurs.  
C.6. Intervention - ViCCY. In addition to augmented standard care HI, caregivers randomized to ViCCY will 
receive 10 front-loaded sessions of virtual health coaching by trained RNs (Section C.6.a) over 6 months with 
content based on the theoretical framework and our prior research (Table 3, next page). As shown in Figure 
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Research Strategy                                                                                             
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3, sessions are weekly initially and decrease in frequency over time. ViCCY incorporates the factors essential 
in caregiver interventions;86 it is a psychosocial approach that is personalized and tailored to be flexible; is 
multidimensional, providing support for coping with perceived stress while fostering self-care; and is sufficient 
in dose, based on our pilot work. We refined our approach based on caregiver input to focus on relieving stress 
rather than intensifying demand and burden,71 thereby promoting caregivers’ ability to respond to stressors 
with adaptive coping. We aim to build 
motivation to gain the knowledge and skills 
needed to achieve self-identified health 
goals.180 We focus on identifying personal 
values, solving problems, and transforming 
goals into action using a combination of 
psychological and behavioral interventions.181  
 
We use motivational interviewing in all 
ViCCY sessions.182 Observations are 
presented to the caregiver in a way that 
builds confidence, motivates action, and enhances self-care by breaking the cycle of negative self-perception 
and emotions with the knowledge, skills, and beliefs needed to engage in healthy behaviors.183-186  We discuss 
goal-setting and action-planning in early sessions. Consistent with motivational interviewing, information (e.g., 
reasons for specific patient behavior) is given only if and when the caregiver is receptive to it. 
 
A series of sessions is provided with the goal of achieving a lasting effect.187 In preliminary studies, we 
found a direct relationship between the number of sessions provided and the effect obtained,166,188 with 10 
sessions of health coaching typically being a sufficient dose.21 Because maintaining contact is important to the 
success of stress reduction interventions,91 the assigned RN will check in with caregivers between intervention 
sessions. We will offer booster sessions to any caregiver in the ViCCY arm who wishes to receive additional 
support during the 6-month intervention interval.21 We will track the number of sessions and test for differential 
effectiveness based on the dose received. If a brief check-in call becomes an intervention session, it will be 
tracked for use in analysis. We will mail monthly newsletters to maximize retention (see Recruitment and 
Retention Plan). Because we found that early and intense contact with the coach builds the relationship, 
engages the participant in the treatment program,189 and maximizes outcomes,190 we will front-load the 
intervention sessions (Figure 3). Consistency is important for trust building, behavioral change, and growth,191 
so one RN health coach will be assigned to work with each caregiver for the full 6-month period. Intervention 
content is carefully standardized, guided by a manual with session agendas and checklist of specific content to 
be covered in each call, but also tailored to allow the coach to focus on caregiver needs, addressing unique 
and varying individual characteristics, preferences, and goals.192,193   
C.6.a. Health coaches. We will hire two baccalaureate-level RNs who have at least three years of clinical 
Table 3. Intervention Content Derived from the Transactional Model of Stress and Coping 
Theoretical Dimension 
Intervention Actions by the RN Health Coach 
Caregiving demand 
Assess caregiving demand (e.g., patient behaviors, communicating with providers, feeling 
isolated).12,18,194 Provide “mutual education” and cross-learning—caregivers educate the RN about 
the nature of their problems and the RN educates the caregiver about the purpose of health coaching 
and how self-care can help the caregiver.  
Primary appraisal 
(significance of the stressor) 
Assess beliefs about HF and personal goals to determine how caregiving demand impacts caregiving 
burden and personal goals. 
Secondary appraisal 
(assess coping resources 
and options) 
Assess perceptions of controllability and self-efficacy in dealing with specific situations. Use goal 
setting to set up discussions of the discrepancy between goals and self-care behavior, ambivalence 
about self-care, and action planning. 
Coping: Problem 
management 
Assess structural and contextual factors influencing coping (e.g., social determinants of health). 
Identify resources needed. Teach practical skills to activate self-care and encourage a sense of 
health ownership (e.g., self-monitoring of thoughts and behavior). Introduce problem solving.195,196 
Emphasize self-care as a pleasurable and healthy method of coping. Discuss action planning, 
emphasizing skills that can help deal with problems (e.g., brainstorming about potential solutions 
when problems seem insurmountable). Teach how to itemize and prioritize questions before 
meetings with providers. Focus on building confidence.  
Coping: Emotional 
regulation 
Teach that avoidant coping styles (e.g., denial) are not helpful.197 Encourage perceptions of 
controllability and self-efficacy as they are associated with engaged coping (e.g. problem-solving). 
Teach relaxation exercises (e.g., guided imagery, controlled diaphragmatic breathing, and 
meditation) early and reinforce throughout to promote emotional regulation.  
Coping: Meaning-based 
coping 
Encourage gratitude to decrease stress and improve wellbeing.198-200 Encourage spiritual beliefs and 
engagement in positive events. Focus on ways to find satisfaction with caregiving. 
Support resources 
Identify interpersonal and community resources available to provide respite and support. 
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experience in cardiac nursing, excellent interpersonal communication skills, and comfort with technology.201 
RNs will receive two days of initial training in health coaching from Dr. Riegel and then complete a 7-hour 
online training program in motivational interviewing provided by the University of Colorado, College of Nursing. 
Thereafter, weekly training and supervision will be conducted by Drs. Riegel and Hirschman as the RNs begin 
coaching caregiver participants. As part of this supervision, audio-recordings of coaching sessions will be 
reviewed by independent raters using the Behavior Change Technique taxonomy.202 Two trained raters will 
judge three randomly selected session recordings for each coach. Raters will assess completeness and 
thoroughness of the therapeutic techniques used, calculating intraclass correlation coefficients as a measure of 
interrater reliability. RNs who receive less than moderate ratings will receive individual session supervision. If 
an RN receives a low rating on any session, s/he will be required to undergo additional training and will be 
suspended from coaching study participants until the deficiencies are remedied. We have had success in this 
approach for recruiting, training, and retaining health coaches engaged in prior trials.23,149,153 
C.7. Internet Access. We will offer a variety of Internet options to participating caregivers. We will offer tablet 
devices, which are versatile for allowing privacy, to all participants. The tablet uses an embedded computer 
camera capable of full 2-way duplex video and audio transmissions for real-time communication. Existing 
broadband Internet connection is not required because we supply devices with mobile connectivity. 
Technology experts (Caryl Technologies, with whom we have worked in the past) will train research staff to set 
up Internet service and devices during an in-person visit and ensure that the system is functioning well before 
research procedures begin. Caregivers will be left with a step-by-step manual and the research office phone 
number in case technology issues occur. If they wish to use their own computer, we will locate the site on their 
computers and ensure that it functions properly. We will provide a camera for anyone in the ViCCY arm who 
wishes to use her/his own computer. If their personal technology proves to be inadequate, we will offer a tablet 
to ensure access to the website and the intervention.  
 
ViCCY sessions will be provided entirely by video-conferencing technology. A secure cloud account will 
be set up for the ViCCY sessions, which will begin within one week of set-up. As described previously, we 
have conducted several funded clinical trials using virtual technology that illustrate our experience with 
installing, teaching, trouble shooting, using, and evaluating such applications in participants’ homes.139,203-208  
Almost all of these studies involved older adults. This experience taught us that the devices are easy to install 
and use. In one typical study with older adults, average use (number of days the equipment was used divided 
by number of days available) was 81% (range 6%-100%).138  
C.8. Process evaluation. Treatment fidelity will be monitored as detailed in Table 4.209-211 To examine whether 
caregivers’ expectations are influencing outcomes, caregivers in both groups will complete the Outcome 
Expectancy and Treatment Credibility Scale212 at baseline and 6 months to facilitate data interpretation. This 
scale has good internal consistency (α=0.85) and has been used in numerous prior studies, including trials in 
which an intervention is delivered by Internet.213,214  
Table 4. Methods of Process Evaluation to Ensure Treatment Fidelity 
Goal 
Strategies 
Study Design  
Ensure that the treatment dose (number, 
frequency, length of contact) is 
adequately described and the same for 
each participant  
• Provide all participants with consistent access to HI 
• Provide all intervention group participants with 10 doses of ViCCY over six months 
• Use a detailed treatment manual with session agendas and checklist of points to 
cover to enhance treatment quality and consistency  
• Use a software program to monitor use of the HI website 
Plan for Implementation Setbacks  
(e.g. coach drops out) 
• Hire 2 RNs, maintain a pool of qualified RNs so that new ones can be trained as 
needed 
• Track attrition (Research Assistants (RAs), RNs, participants) and reasons for dropout 
Coach Training  
Standardize training to ensure that it is 
conducted similarly for all RNs. Train 
RNs to well-defined performance criteria 
• Train RNs together using standardized training manuals and the same instructor 
• Design training to accommodate individual styles while assuring standardization 
• Specify performance criteria a priori  
• Provide remedial training immediately when problems are detected 
Treatment Delivery  
Monitor and control for treatment 
differences 
• Monitor all encounters, with deviations from protocol addressed quickly  
• Assure that a single RN is assigned to provide ViCCY for each caregiver for continuity 
• Randomly choose 3 early ViCCY sessions per RN to audio-record and rate for fidelity  
• Provide routine supervisory oversight using fidelity ratings to minimize decay or drift 
• Assure that RNs self-monitor, completing an intervention log after each contact 
Treatment Enactment 
Monitor and control for participant 
perceptions of RN differences (e.g., 
warmth, credibility) 
• Assess participant perceptions of RNs’ characteristics through intermittent phone calls  
• Give feedback to RNs and mentor them to rectify complaints  
• Analyze treatment enactment data after 50%, 75%, and 100% of participants are 
recruited and compare by group (ViCCY and HI)215 
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C.9. Caregiver Characteristics and Outcomes. On enrollment, the RA will collect self-report data from 
caregivers using encrypted laptop computers. Data will be entered directly into the REDCap database as 
collected, with data entry screens designed to incorporate range checks and concurrent checks to minimize 
errors. Caregiver burden216 will be measured using the Dutch Objective Burden Inventory (alpha coefficient 
0.81-0.84, construct validity), which measures the full range of activities required to care for HF patients 
(demand) as well as the burden associated with these demands.217,218 Quality of the relationship with the 
patient; social determinants of health; and demographic, caregiving, and clinical characteristics will be 
gathered from caregivers at enrollment only. At 3, 6, 9 and 12-months post randomization we will telephone 
caregivers and collect self-report data on self-care, stress, coping, and health status (Table 5). At 12 months 
we will measure QALYs.  These data will be obtained by interview and entered directly into REDCap using 
encrypted laptop computers. Self-report instruments with demonstrated cultural-sensitivity and prior validity 
testing in caregiving samples were chosen, and measures are as brief as possible to minimize burden. 
C.10. HF Patient Characteristics. With patient consent, HF patient demographic and clinical characteristics 
will be abstracted from the medical record at enrollment. Duration of HF will be measured in months. All 
comorbid conditions will be noted and classified using the Charlson Index.165 Physician ratings of New York 
Heart Association functional class as noted in the EMR at enrollment will be used to describe HF patients. The 
SF-6D will be administered to HF patients at baseline and 12 months to obtain QALYs.40 
Table 5. Caregiver Outcome Variables and Measurement 
Definition and Measure 
Items 
Item responses 
Reliability  Validity 
Comments 
Self-care (behaviors 
undertaken to maintain 
health). Health Self-Care 
Neglect (HSCN) scale35 and 
the short Health-promoting 
lifestyle profile (HPLP) II.219  
10 
 
30 
 
HSCN dichotomous.  
HPLP 4-point Likert scale; 
higher score = more healthy 
behavior.  
0.76 
 
0.90 
Content 
 
Criterion 
Convergent 
Divergent 
Construct 
The HSCN has not been widely tested 
so we augment this measure with the 
widely-used Health-promoting lifestyle 
profile II. To minimize burden, we will 
use the short form.  
Stress (demands exceed 
ability to cope). Perceived 
Stress Scale (PSS).36  
10 
5-point scale (0=never to 4=very 
often).  
0.84-0.86 
Concurrent 
Predictive 
Construct 
Gold standard for assessing stress.220 
Norms are available for comparison.  
Coping (ability to respond to 
stressors with appropriate 
adaptive coping resources).121 
Ways of Coping 
Questionnaire, short form.38 
30 
4-point Likert-scale response 
format (0 = not used to 3 = used 
a great deal); higher scores 
indicate greater coping. 
0.95 
Construct 
The original scale has been used widely 
since developed by Lazarus in 1985. 
This short version has been used 
numerous times in studies with older 
adult caregivers.221-225 
Health status (physical and 
mental health).  Medical 
Outcomes Study Short form 
(SF)-36.136,137  
36 
Varied (3-, 5- and 6-pt scale and 
dichotomous [yes/no]); each 
component score is 
standardized 0-100 point scale.  
>0.80 
Convergent 
Divergent  
Standardized scores and national norms 
for comparison. SF-36 valid in many 
populations,39,226 and caregivers.227,228 
One of the common data elements.  
Quality of the relationship 
scale229 measures giving and 
receiving support.  
10 
4-point Likert scale (never to 
always).  
0.85 
Predictive 
Adapted to be used with couple or 
parent–child relationships.109  
Demographic 
characteristics and social 
determinants of health 
influence self-care.230-234  
 
 
 
 
Collected with the Protocol for 
Response to and Assessing 
Patient Assets, Risks, and 
Experiences (PRAPARE).235 
Standardized 
measure of 
individual level 
data 
 
Age, race, sex, education etc. (common 
data elements), money, resources (food, 
housing), social and emotional health, 
support (transportation, safety)  
Caregiving characteristics 
assessed in HF studies.236-240  
 
To be collected at baseline in 
sociodemographic survey 
 
 
Relationship to the patient, time spent 
caregiving (historical, daily)  
Chronic conditions and 
medications. Interview 
format of the Charlson 
Comorbidity Index.241   
11 
Chronic conditions (most scored 
1 point. Scores range from 0 to 
34).241 Self-report of medicines. 
 
-- 
Predictive 
 
 
 
Caregiver Health Characteristics: 
• All medications including over-the-
counter and herbals, by interview. 
• All chronic conditions 
Work performance [lost 
productivity due to time away 
from work (absenteeism) and 
reduced efficiency at work 
(presenteeism).242 7-day work 
performance questionnaire.243 
13 
Interview format. Varied (10-pt 
scale and dichotomous [yes/no] 
and number hours spent per-
forming paid and unpaid work 
0.73 
Predictive 
Concurrent 
Construct 
Caregivers will be interviewed at 
baseline, 3-, 6-, 9-, and 12-months to 
assess lost productivity. 
C.11. Health care utilization outcomes: Caregivers and patients. Health care utilization of both caregivers 
and consenting HF patients will be obtained from the EMR for 12 months before and 12 months after 
randomization using a process of active surveillance (Table 6). The Penn Data Store will monitor inpatient and 
outpatient activity and generate automated reports for tracking of mortality. As EMR data may be incomplete if 
a person is hospitalized outside the Penn health system, caregivers will be asked about their health care use 
when they are telephoned at 3, 6, 9, and 12 months. If the patient in their care has provided consent, we will 
also ask the caregiver about HF patient hospitalizations outside the Penn health system. We will ask about all 
major categories of use including provider visits, hospitalizations, emergency department (ED) visits, 
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diagnostic and therapeutic procedures, ambulance services, and home care services received. RAs blinded to 
study group will perform these assessments.  
C.12. Database Set-up and Management. REDCap (Research Electronic Data Capture) will be used as a 
central resource for data processing and management. REDCap is a web application and back-end database 
model designed to support data capture for research.252 REDCap was developed around HIPAA-security 
guidelines with features such as data encryption. It provides an intuitive interface for data entry with data 
validation, audit trails for tracking data manipulation and export procedures, automated export procedures for 
seamless data downloads to common statistical packages, and procedures for importing data from external 
sources. We will use standard operating procedures to guide all data management activities, such as the 
naming of variables, data cleaning and handling of missing data. Missing fields will not be allowed except in 
certain pre-specified cases (e.g., income).  
C.13. Power. We will enroll 250 caregivers (125 caregivers per study arm) to achieve over 90% power to 
detect significant overall differences in longitudinal profiles between the groups on the primary outcome of 
Health Self-Care Neglect Scale.35 Assuming estimates similar to those in our pilot data, and extrapolating 
through 6 months, along with control group scores that also decline over time (due to interaction that comes 
with participation in a clinical trial) but at a slower rate than the intervention, it is assumed that ViCCY 
caregivers will demonstrate mean Health Self-Care Neglect scores of 3.2, 1.25, 1.1 while HI caregivers will 
demonstrate mean scores of 3.2, 3.0, 2.7 at baseline, 3, and 6 months, respectively. Combining the two data 
sets, this translates to mean scores of 1.85 and 2.97 (D=1.12) overall for intervention and control group 
caregivers, respectively—in line with a clinically meaningful difference equal to 0.4*SD (SD 2.8)=1.12 units.253 
We conservatively assumed that standard deviations (pilot estimates 2.5 and 1.3 at baseline and 3 months) 
are constant over time, equal to 2.8, and that the variance-covariance matrix pattern is generated using a 
mixed effects model design (congruent with the primary analytic plan) with a first-order auto-correlation 
parameter equal to 0.3. A design with three assessment points and 100 participants per group (200 total) 
achieves 99% power to test the overall between-group effect (intervention vs. control without regard to 
changes over time), 99% power to test the overall time effect, and 90% power to test the group x time 
interaction effect. All tests are based on simulations with 100 iterations, a 5% significance level, mean vectors 
and variance-covariance as described above. We anticipate 20% attrition based on our prior experience with 
the intervention, which was found to be helpful, supportive, and stress relieving rather than burdensome. 
Further, we will remunerate caregivers for their time and effort (see Human Subjects). 
C.14. Data Analysis Plan. All analyses will use an intent-to-treat approach. Descriptive statistics will be used 
to characterize the sample, with measures of central tendency and variation for continuous measures, and 
frequencies and percentages for categorical variables. Distributional properties will be examined to determine if 
variance stabilizing or normalizing transformations should be applied. Non-inferential interim analyses will be 
performed to ensure data collection and archiving procedures are operating correctly. Outliers will be assessed 
by visual inspection and checked for accuracy. Once the database is locked, comparisons by group will assess 
for balance and identify multi-collinearity and areas requiring statistical adjustment. For comparisons involving 
continuous variables, homoscedasticity will be evaluated using Levine’s tests. Normality will be assessed using 
Shapiro-Wilk tests. Should violations emerge, transformations will be applied or non-parametric tests used. 
 
While every effort will be made to obtain complete data on every participant, some missing data are 
inevitable.254 The underlying mechanism—missing completely at random (MCAR), nonignorable or not missing 
at random (NMAR)—will be evaluated prior to adjusting to minimize bias from missing data.255-257 We expect 
most missing data to be MCAR (e.g., finding data collection burdensome). However, systematic bias may exist 
for those who withdraw so baseline characteristics will be compared among those with and without complete 
Table 6. Cost Effectiveness Data to be Collected on Caregivers and HF Patients  
 
Variable 
Definition and Comment 
Measures 
QALYs 
QALYs are derived from the SF-36 because the SF-6D based on the SF-36 is more discriminative than 
that derived from the SF-12.244 
SF-36 
Hospital 
readmission 
rates 
Risk-standardized all-cause readmission rates (RSRR) endorsed by the National Quality Forum245 as a 
measure of hospital performance and aligns with published standards for statistical models used for 
calculation and public reporting of health outcomes and efficiency measures.246 
 
EMR 
Days in the 
hospital  
Captures the natural history of the multimorbid HF patient experience.247 Used to describe the burden of 
disease from the individual and healthcare system perspectives248 and in previous trials.249-251  Maximal 
exposure of 365 days. 
EMR 
Resources 
used 
Provider visits, hospitalizations, ED visits, diagnostic and therapeutic procedures, ambulance services, 
and home care services 
EMR 
Death 
If we suspect that the patient is dead, we will use family, then local, then national resources to confirm. 
EMR 
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follow-up data. To assess potential biases, we will compare withdrawal rates and time to withdrawal.258,259 If the 
number lost to follow-up is small (< 5%) and the missing observations can be considered MCAR, then the 
primary hypotheses will be tested using the complete observed data. If missing observations cannot be 
assumed to be MCAR, more complex approaches will be considered such as shared parameter models260 or 
random pattern-mixture models.261-263 Sensitivity analyses for these models will be performed.264 These 
approaches assume that participants dropped out for either informative (e.g., illness exacerbation) or non-
informative reasons (e.g., withdrawing consent). If dropouts are informative, we will adjust for this potential bias 
by introducing a covariate(s) into the analysis to help to explain why participants dropped out early.  
 
To assess changes in each of the primary and secondary outcomes over time, separate mixed effects 
regression models will be generated with SAS Proc Mixed.265 We are not powered for secondary outcomes 
(e.g., stress, coping, health status), but we will examine effect sizes and confidence intervals (CIs) to 
determine if lack of power is driving nonsignificant results. Mixed models can account for correlation between 
repeated measures and handle non-excessive MAR or MCAR data better than traditional models and allow for 
use of time-independent and time-dependent covariates.266 Both random slopes and random intercepts will be 
modeled to represent deviations from the average, or fixed-effect, slope over time and intercept, respectively. 
REML will be used for parameter estimation and the most appropriate covariance structure will be examined. 
Scores will be analyzed as repeated observations, with mean-centered baseline outcome scores serving as a 
covariate. Other predictor variables will include group, assessment time, and the interaction of group time 
(primary effect of interest). Baseline measures and group will be analyzed as time-independent covariates. The 
evaluation of differences in outcome profiles over time according to group will rely on the group x time 
interaction terms, while differences by the balancing variables will rely on the mixed-effects modeling of higher 
order interaction terms.267-270 Statistical significance for individual intervention contrasts will be evaluated for 
each outcome, applying the Benjamini & Hochberg271 method to control for the type I error rate at 5%. The 
Akaike information criterion (AIC)272 will be used to evaluate overall model fit and to select the best-fitting 
longitudinal change pattern. We expect the groups to be balanced on baseline characteristics due to 
randomization; however, imbalances that occur by chance will be adjusted for in all analyses. Time-dependent 
covariates of perceived stress and potential moderating effects of natural support or an intervening 
hospitalization will be examined in exploratory models. Using methods described above, time-specific contrasts 
will be estimated to evaluate differences in outcome within groups at 9 and 12 months.  
C.14.2. Aim 2: To estimate the cost and cost-effectiveness of ViCCY over 12 months. We hypothesize 
that caregivers randomized to ViCCY vs. HI only will have H2a: Higher QALYs measured with the SF-6D 
derived from the SF-36;40 and H2b: Lower health care resource use. The primary outcomes of this analysis 
include the difference in costs (intervention cost minus cost offsets), the difference in QALYs measured with 
the SF-6D,40 and the incremental cost effectiveness ratio (the difference in costs divided by the difference in 
QALYs). Costs will include both the costs of intervention implementation (number and length of intervention 
contacts, RN time to assess need for and delivery of the intervention, technology expenses, supervision time, 
and initial training). Cost offsets include the costs of health care (detailed below) and the difference in 
workplace productivity collected for both study groups. QALYs will be used to assess effectiveness. We 
hypothesize that compared to HI, ViCCY will require more resources for intervention implementation, but will 
reduce use of other health care resources. It is unclear if the changes in health care resource use or labor 
productivity will fully offset the intervention implementation costs (leading to a finding of dominance: lower cost 
and greater effect) or if net costs will be positive (leading to a finding of cost-effectiveness). We will follow a 
micro-costing approach in which all clinically relevant resources used in the study groups will be tracked and 
converted to costs using appropriate price weights.   
 
We will obtain and summarize all health care use and convert it to payer costs (i.e., a payer’s 
perspective) by use of Medicare fees. Many, if not most, of the anticipated participants will be over 65 years 
old, which makes Medicare fees appropriate for the analysis. Fees will be derived from the last study year, so 
there will be no need to adjust for inflation. Because follow-up will be for a year, at most, there will be no need 
to discount costs. Medication costs will be based on average wholesale prices adjusted to average sales prices 
as reported by the U.S. Office of the Inspector General.273 We will evaluate the effect of a reasonable range of 
private sector cost estimates in sensitivity analyses. Costing methods will adhere to standards proposed by the 
US Public Health Service-sponsored Panel on Cost-Effectiveness in Health and Medicine.98 Resources and 
costs associated with research and data collection will be excluded from analyses. Sensitivity analyses will be 
performed using self-reported information on key variables (e.g., exploring alternative outcomes across a 
range of outcome CIs). We have used these procedures successfully in prior studies.8,274,275  
 
 Resource utilization and cost comparisons will be examined overall and by resource category over four 
Contact PD/PI: RIEGEL, BARBARA J
Research Strategy                                                                                             
Page 83

time periods (0-3 months, 3-6 months, 6-9 months; and 9-12 months), with the main outcome at one year. 
Statistical comparisons will be performed using generalized estimating equations (GEE) with links selected 
using the Pearson correlation test, the Pregibon link test, and the modified Hosmer and Lemeshow test, and 
families selected using the modified Park test.276 Estimates of average total treatment costs and QALYs will be 
generated separately for each group. Non-parametric 95% CIs will be determined for group differences in 
mean total costs using empirical sampling distributions (1,000 iterations) generated with bootstrapping 
methodology with replacement.277,278 We will compute a non-parametric two-sided p-value based on the 
empirical sampling distribution. Differences in cost and QALYs will be used to calculate the incremental cost-
effectiveness ratio. Reported measures of sampling uncertainty for this ratio will include 1) the plot of the joint 
distribution of the difference in cost and effect on the cost-effectiveness plane, 2) the confidence interval for the 
cost-effectiveness ratio calculated by use of the Fieller’s theorem method, and 3) the acceptability curve.98 
Sensitivity analysis is a critical component of an economic evaluation since all assumptions and parameter 
estimates have uncertain precision.98 As more than one approach is often available to monetize outcomes, we 
will calculate a lower and upper bound estimate, as relevant, for the benefit (QALYs) and cost calculations. We 
will combine this series of sensitivity analyses to form a lower and upper bound estimate for preliminary ICER.  
C.14.3. Aim 3 (Exploratory): To explore the effect of caregiver outcomes (self-care, stress, coping, 
health status) on HF patient outcomes. We hypothesize that at 12 months, HF patients whose caregivers 
improve vs. not improve in self-care (regardless of group) will have H3a: Lower hospitalization rates; H3b: 
Fewer hospital days; H3c: Lower mortality rates; and H3d: Higher QALYs measured with the SF-6D.40 We will 
analyze number of hospitalizations and days in the hospital using GEE regression models with the Poisson 
distribution as the working outcome distribution. GEE allows for modeling of the marginal distribution of each 
outcome variable as a function of the caregiver predictor of interest over time, and accounts for the likely 
correlations of the repeated outcome measures for each participant. An approach similar to that described for 
Aim 1 will be used within the GEE framework (different correlation structures will be examined, baseline 
outcomes will be included as a covariate).  
 
We will measure time to death from date of the caregiver’s enrollment in the study to the date of patient 
death. Patients remaining free from an event will be censored at their last follow-up. Kaplan-Meier estimates 
will be plotted to provide a visual demonstration of time to death by group (categorized caregiver outcomes), 
and the log-rank test will be used for comparisons. GEE and frailty type multivariable modeling will be applied 
to time-to-event data within the context of equally spaced time intervals.279-281 This approach allows for the 
addition of a random effect to a general Cox proportional hazards model to account for the likely correlation of 
repeated measures for each study participant while also accounting for censoring.  
 
QALYs will be analyzed using mixed effects regression modeling. As described above, scores will be 
analyzed as repeated observations, with mean-centered baseline outcome scores serving as a covariate. Other 
predictor variables will include time-dependent caregiver variables, assessment time, and the corresponding 
two-way interaction term (primary effect of interest). Statistically significant findings will be concluded on the 
basis of a two-sided 0.05 level of significance, recognizing these analyses are exploratory in nature and 
findings will be used to generate hypotheses. Finally, we will examine the effect of caregiver outcome on HF 
patient outcomes in patient-caregiver dyads using the Actor-Partner Interdependence Model.282 
C.15. Methodological challenges. We have considered the following methodological challenges: 
1. There is the possibility of differential compliance with the protocol – for instance, if the HF patient has an 
exacerbation that distracts the caregiver and interferes with the intervention or assessments. We will allow 
some flexibility in the timing of ViCCY sessions to accommodate such events and increase the 
generalizability of study results. Caregivers in the ViCCY arm will be able to schedule calls with the RN 
coach during day, evening, and weekend hours to limit stress from study participation. For both arms, we 
will allow data collection calls to be completed up to two weeks before or after the planned contact date to 
accommodate schedules. We will collect data on cancelled and delayed events for later analysis and adjust 
for delays and the dose of intervention received in analyses.  
2. A threat to validity includes the potential for the control group to receive a level of natural support sufficient 
to interfere with our ability to detect treatment effects from ViCCY.283  We will interview participants about 
naturally occurring support so that we can adjust for this in the analysis if needed.  
3. We may have difficulty enrolling the most stressed and burdened caregivers who may see the trial as one 
more demand; however, in pilot testing we found that caregivers were grateful for the support.  
4. It is possible that the patient could die during the year in the study; half of all HF patients die within 5 
years.11 Should this occur, the caregiver will be dropped from the study.  
Contact PD/PI: RIEGEL, BARBARA J
Research Strategy                                                                                             
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Crawford SL, Tennstedt SL, McKinlay JB. A comparison of analytic methods for non-random 
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References Cited                                                                                              
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Recruitment and Retention Plan 
 
We plan to enroll a consecutive sample of 250 informal caregivers (125/arm) of heart failure 
(HF) patients (HF caregivers). The main enrolment site is the Penn Heart and Vascular Center 
(PHVC), the largest outpatient HF clinic in the Philadelphia region and a site at which the 
Principal Investigator (PI) has established relationships and success in past recruitment of 
participants. If recruitment is slower than expected, we will identify caregivers visiting HF 
patients hospitalized at one of three University of Pennsylvania Health System (UPHS) sites.  
 
We anticipate identifying 100 unique HF patients each month, most of whom will have 
caregivers. Based on our prior research, we anticipate that 90 will have caregivers and 70% of 
these (63 caregivers) will be eligible, and 15% will enroll. Thus, we estimate enrolling 10 
caregivers per month. Using this number, we anticipating needing at least 25 months for 
enrollment, but we have conservatively allowed 30 months for enrollment and five years to 
complete the study. 
 
In addition to caregivers, we want to enroll at least 40 caregiver-patient dyads. We understand 
the challenges of enrolling dyads, but 40 dyads is sufficient to provide reliable parameter 
estimates for this exploratory aim. The effort of HF patient participants is minimal. They will not 
receive an intervention. They will be asked to provide informed consent to allow us to access 
their electronic medical record (EMR) to collect clinical information and track events and, in the 
case that patients receive care outside the Penn health system, for the caregiver to report on 
patient health care resource use. At the end of the study period (12 months), the HF patients will 
be asked to provide data on quality adjusted life years (QALYs).  
 
We will have a study Research Assistant (RA) on site during PHVC clinic hours so that the RA 
can meet the informal caregiver in person because we anticipate that a face-to-face meeting will 
maximize enrollment. We plan to seek a HIPAA waiver to screen the daily appointment 
schedule to identify every patient with a potentially eligible caregiver (e.g., living within 50 miles 
of the research office). Dr. Wald, a co-investigator on the study, will ask clinic staff to identify 
potential caregiver participants (e.g., speak English) and determine their willingness to speak 
with research staff about the study.  
 
To facilitate the engagement of clinic staff, we will meet with them before the study begins to tell 
them about the study. We will bring lunch to compensate their time in talking with us. We will 
use that forum to build enthusiasm about the study. We will hold similar events throughout the 
enrollment period to assure that engagement of staff in enrollment does not wane. During these 
subsequent events, we will update the clinic staff on our progress.   
 
We will prepare informational materials for the clinic staff to use to engage the interest of 
informal caregivers. These materials will use clear and simple language with graphics that 
portray caregivers of different ages and races. We will place these materials in the waiting 
rooms, at the front desk, and in all the examination rooms. Research staff will make sure that 
these materials are consistently available.  
 
If we need to enroll from the hospital because enrollment is not sufficiently brisk in the clinic, an 
RA will be available in the hospital daily to give interested caregivers study information and 
conduct screening. We will obtain a HIPAA waiver to allow us to screen the daily admission log 
to identify every HF patient with a potentially eligible caregiver (e.g., living within 50 miles of the 
research office). We will engage hospital staff in a manner to that described above for clinic 
staff. 
Contact PD/PI: RIEGEL, BARBARA J
Recruitment and Retention Plan                                                                                
Page 91

 
We recognize that some caregivers will learn about the study in the clinic or hospital but not 
decide to participate until after they are home. For these situations, we will have a dedicated 
telephone number and email address for potential participants to learn more about the study. 
Anyone who contacts us in this manner will receive a response within 48 hours. 
 
If we find that we are unable to recruit a diverse racial/ethnic sample, we will identify additional 
community agencies and other clinics that serve different racial and ethnic populations. We will 
work with staff at those clinics to facilitate successfully on-site recruitment. Recruitment flyers 
will reflect images and language that speak to a diverse population.  
 
Our training of staff will emphasize good clinical practice in working with study participants. Staff 
training will include developing cultural competency (cultural awareness, knowledge, and skills) 
in working with diverse populations, participant recruitment, and follow-up activities. Our goal is 
to minimize language and communication problems to support retention and engagement. For 
example, we will make sure that the reading materials are written at a basic reading level. Print 
will be sufficiently large to accommodate age-related vision changes. Regular staff meetings will 
provide further opportunity for continued cultural competency training and discussion.  
 
From experience, we recognize that identifying the ideal way to recruit participants is 
challenging. Issues that impede enrolment include lack of staff engagement, resistance from 
unexpected sources, and RA staff turnover. We will meet with research staff at least weekly to 
monitor these issues and any others that arise. We will monitor our processes intensely until we 
have identified a successful method of enrolling caregivers. Thereafter, we will continue to 
monitor our processes regularly. 
 
Retention 
Once enrolled, it is important that we keep participants in the study for the full 12 months. We 
will monitor retention regularly and discuss retention trends at monthly meetings of the full study 
team. Our plans to accomplish this goal address contact frequency, tokens of appreciation, 
newsletters, and remuneration. 
 
We will contact all participants at 3 month intervals by telephone for data collection. We will use 
these calls as a method to keep participants engaged. On enrollment, we will clearly explain the 
requirements of the study to all participants. We will specify that we need to speak with them 
every 3 months, asking “What is the best way for me to contact you?” We will obtain several 
phone numbers (home, work, and cell) and an email address whenever possible so that we can 
follow up with them easily. We will be flexible when scheduling appointments. We will carefully 
train the RAs to be polite, thoughtful, and sensitive to the stresses these informal caregivers are 
experiencing. 
 
We will mail a regular newsletter that reports the progress of the study to keep the participants 
engaged. We will write this newsletter it in such a way that it can be distributed to participants in 
both the intervention and the control groups. 
 
We will send participants small tokens of appreciation that will remind them of the study: 
birthday cards, refrigerator magnets and pens with the study logo, etc. For remuneration, we 
chose a market model of payment where the amount serves as an incentive rather than a 
reward. The advantage is more rapid recruitment and avoidance of subject financial sacrifice. 
Further, a completion bonus encourages subject retention. Using this model, caregivers will 
receive $25 at enrollment, $50 after the 6-month data are provided, $25 after the 9-month data 
Contact PD/PI: RIEGEL, BARBARA J
Recruitment and Retention Plan                                                                                
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are provided, and $100 when they complete the study for a total remuneration of $200 for a 12-
month commitment.  
  
We have procedures planned and itemized in the research strategy for monitoring intervention 
fidelity. We anticipate that many of these procedures (e.g. health coach consistency for each 
participant in the intervention) will facilitate retention of participants.  
 
At the end of the study, we will distribute research results to all participants in formats that are 
useful to the different communities involved (e.g., participants, families of participants, and 
referring practitioners). For participants, we will explain how the findings may ultimately improve 
their health. For health care practitioners, we will summarizes the findings succinctly to 
accommodate their busy schedules. 
 
Contact PD/PI: RIEGEL, BARBARA J
Recruitment and Retention Plan                                                                                
Page 93

 
 
 
Estimated Timeline for Major Study Activities 
YEAR 1 
YEAR 2 
YEAR 3 
YEAR 4 
YEAR 5 
Activity 
Quarters 
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 
Hire and train the Project Manager  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop databases, refine study materials 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Obtain IRB approval 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hire, orient, train research and clinical (health coaches) staff 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prepare for sample enrollment with clinic staff meetings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sample enrollment and data collection  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data entry and data cleaning  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Provide intervention, actively monitoring treatment fidelity 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection finishes, final cleaning of all data 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete data analysis  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disseminate results 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Contact PD/PI: RIEGEL, BARBARA J
Study Timeline                                                                                                
Page 94

HUMAN SUBJECTS 
This Human Subjects Research meets the definition of ‘Clinical Research’.  
Protection of Human Subjects 
Human Subjects Involvement, Characteristics, and Design. In the proposed RCT we will enroll adults who are 
informal caregivers of adults with heart failure (HF) and the HF patients they care for. The study focuses on the 
caregivers, but we will also enroll all willing HF patients to address our exploratory aim. We will seek HF patient 
consent to review their medical records for factors anticipated to add to the demand of caregiving (e.g., number 
of comorbid conditions) and health care resource use. QALYs will be collected from consenting HF patients. 
The informal caregivers and the HF patients are anticipated to be primarily older adults because HF is a 
condition affecting primarily elders. In our most recent study of this population, the mean age of HF patient 
participants was 62 ± 12.5 years and most of their caregivers were spouses of a similar age. Considering the 
age group, most caregivers will have one or more chronic conditions.  
The sampling plan involves enrolling a consecutive sample of adult caregivers and patients with chronic HF, 
whenever possible. We will focus enrolment on caregivers, approaching them after staff obtain permission 
during a clinic visit or during a hospitalization of the HF patient. Caregivers must be informal caregivers of 
patients with a confirmed diagnosis of HF. They will be screened with the 10-item Health Self-Care Neglect 
scale;1 we will enroll only those who are poor in self-care using a cut-point of ≥2 based on our pilot study. 
Caregivers must be able to provide informed consent (speak English, see, hear, cognitively intact) and 
complete the protocol. We recognize that we may need to make a home visit to complete enrollment and/or set 
up tablets, so caregivers must live within 50 miles of the research office. We will exclude caregivers with 
cognitive impairment because we anticipate that they would have difficulty completing the intervention. We will 
exclude anyone with untreated major psychiatric illness such as psychosis. Anyone who is planning to move 
out of the area will not be enrolled. Anyone in a competing trial testing a support intervention also will be 
excluded. In this way, we anticipate enrolling only caregivers who are able to provide true informed consent 
and those who will potentially benefit from the intervention. Any HF patient cared for by an enrolled caregiver 
will be consented, if willing. We anticipate, however, that some patients will refuse. In this case, we will enroll 
only the caregiver.  
The PI, Dr. Riegel will oversee the recruitment and enrollment of caregivers. We anticipate enrolling a diverse 
sample of participants, with many in vulnerable racial, socio-economic, and geographically disadvantaged 
groups. We acknowledge that there will be too few Asians and Hispanics to analyze in a meaningful way but 
we will include these caregivers and analyze their data in an exploratory fashion. We expect to enroll women 
more easily than men because most caregivers are women and this type of intervention is more appealing to 
women.2 Recruitment efforts will focus on enrolling a sufficient number of men so that we can analyze sex-
based differences in response to the intervention. We will balance sex and the nature of the relationship 
through block randomization to groups as we enroll. We will not include caregivers of children with HF; HF in a 
child is unusual. No caregivers who are < 18 years of age will be included because their stresses may be 
unique. No vulnerable populations will be enrolled.  
The randomization sequence will be generated a priori by a statistician unassociated with the study. Study 
nurses and caregiver participants will be notified of their group assignment by the Project Manager. Both 
groups will receive Health Information (HI) delivered by the Internet (http://www.nhs.uk/pages/home.aspx) in 
addition to standard care. The intervention group will receive virtual health coaching (ViCCY) by video 
conferencing, with 10 front-loaded health coaching contacts over six months. This dose is based on published 
data demonstrating that six months of health coaching is needed to be effective.  
No other collaborating sites are involved. 
Sources of materials. The research material obtained from caregivers will be primarily self-report surveys (e.g., 
self-care, stress, health status) and clinical information such as names of medications. The self-report 
measures will be collected five times over the course of 12-months (baseline and 3, 6, 9, and 12 months). On 
enrollment, illness-related information and caregiver burden will be measured. 3,4 Quality of the relationship 
with the patient; social determinants of health; and demographic, caregiving, and clinical characteristics will be 
gathered from caregivers at enrollment only. Three randomly selected ViCCY sessions delivered by each 
health coach will be audiotaped, reviewed and rated for fidelity.  
We will enroll HF patients whenever possible so that we can review their medical records to obtain information 
Contact PD/PI: RIEGEL, BARBARA J
Protection of Human Subjects                                                                                  
Page 98

to describe their HF illness severity, HF duration and comorbid conditions. If comorbidity of the patients differs 
between the groups we will use comorbidity as a covariate in analyses. We will also track hospitalizations, 
emergency department visits, and mortality in HF patients over the 12 months of the study to test our 
exploratory aim. 
Because study participants are to be followed for 12-months, a central data file with subject name, phone 
number, email address if available, and address (needed to arrange data collection if no clinic visit is 
scheduled) will be kept by the PI and Project Manager. The research staff directly involved in data collection 
will have access to these data, but in the electronic file all identifying information will be removed and 
participants will be identified only by numbers. Only the PI and the Project Manager will be able to link the 
participant with his or her identification number. 
Potential Risks. Participants will be monitored continually for the occurrence of adverse events defined as any 
untoward or unfavorable occurrence. Potential risks for caregivers include fatigue from data collection, stress in 
response to data collection or some element of the intervention, and loss of confidentiality. The most likely risk 
is fatigue, discussed further below. Patients are at risk for loss of confidentiality because we will be reviewing 
their medical records. Although the risk of a loss of confidentiality is possible for both caregivers and patients, it 
is judged to be unlikely as we are experienced in systems of protecting private information. All data are stored 
behind multiple firewalls. It is monitored regularly, and is accessible only to key personnel who receive private 
network/firewall, server/password, and data directory access rights. Thus, the risk of unlawful penetration is not 
a significant data safeguard concern. 
Fatigue is anticipated in this study; some caregivers will be fatigued by data collection on top of their usual 
caregiving responsibilities. Survey data collection will take place five times and is anticipated to require less 
than one hour. We have streamlined data collection significantly by choosing short measures and those that 
can be administered by telephone. We will accommodate any request to break up the data collection into two 
separate sessions that can be scheduled up to two weeks apart.  
Stress from data collection and/or the intervention is possible as the topics covered (e.g. demand of 
caregiving) may cause emotional distress. Empathy will be emphasized in the training of health coaches as a 
way to minimize distress. All RAs will be trained on how to approach the topics in a non-suggestive yet 
supportive and empathetic way to minimize distress.  
Adequacy of Protection Against Risks 
Recruitment and Informed Consent. After approval by the Institutional Review Board (IRB) at Penn, the 
research staff will work with staff from the HF clinic to identify eligible caregivers for referral to us. If enrollment 
from the clinic is slow we will also look for hospitalized HF patients. Once identified, those caregivers will be 
contacted by the providers to ask about their willingness to speak with the study team. Those agreeing to 
speak with us will have the study carefully explained to them by the research staff. Potential participants will be 
fully informed regarding the interventions and the schedule of the data collection. Those willing to be screened 
will undergo preliminary screening to assess inclusion and exclusion criteria.  
Written informed consent will be obtained from caregivers and HF patients. Those who agree to participate will 
be asked to read and sign the consent form with integrated HIPAA authorization information (i.e., specifics 
about data elements to be collected and use of the private information). The consent form will specify that 
some intervention sessions will be audiotaped to ensure the quality of the intervention and judge treatment 
fidelity. We will explain that these audiotapes will be transcribed for analysis and then destroyed. The RAs will 
answer questions and make sure that the procedures that are to be used are fully understood.  
As stress from study participation is the most concerning risk to caregivers, we will systematically monitor to 
assure that we identify it. We anticipate that stress may result in early withdrawal so we will monitor withdrawal 
rates methodically in each group. If a participant withdraws, reasons will be carefully noted. 
As data collection is anticipated to require significant commitment and effort on the part of subjects, 
remuneration will be provided. We carefully considered the amount to pay participants using the guidelines 
from Dickert and Grady.5 Because of the potential burden of data collection, we chose a market model of 
payment where the amount serves as an incentive rather than a reward. The advantage is more rapid 
recruitment and avoidance of subject financial sacrifice. Further, a completion bonus encourages subject 
retention. Using this model, caregivers will receive $25 at enrollment, $50 after the 6-month data are provided, 
$25 after the 9-month data are provided, and $100 when they complete the study for a total remuneration of 
Contact PD/PI: RIEGEL, BARBARA J
Protection of Human Subjects                                                                                  
Page 99

$200 for a 12-month commitment. This amount is not anticipated to be undue inducement, considering the 
effort and commitment required of participants.  
Protection Against Risk. Fatigue. To minimize the most likely risk of fatigue during data collection, we selected 
surveys that are as short as possible. Completion of the self-report survey packet requires less than one hour. 
Testing will be scheduled at a time that is convenient for subjects. If participants are too fatigued to complete 
all measures, sociodemographic and clinical data will be administered at enrollment and the baseline surveys 
will be gathered in a subsequent telephone call (but before randomization). All delayed data collection will 
occur within a two-week interval. The RAs will be trained to be sensitive to signals from participants that a 
break is needed during testing. All participants will be informed that they can stop their participation in the 
study at any time. For subjects who find data collection too fatiguing, we will offer the option of providing only 
the most essential data reflecting the key outcome variables (e.g., health self-care neglect).  
Stress. To minimize the risk of stress during data collection the RAs will be trained to be supportive and helpful 
to participants with questions about data collection. If a participant becomes stressed during data collection 
because of the questions asked, the burden of data collection, or for other personal reasons, data collection 
will be terminated, delayed, or abbreviated to only the most essential items (e.g. primary outcome variable). 
Significant stress will be reported to the Project Manager who will contact the caregiver to discuss the issue if 
indicated (the PI is blinded). The RAs will be trained to detect any signals that the participant is becoming 
upset before stress escalates. In a prior study we hired nursing and psychology students as RAs, which 
facilitated the assessment and management of participant stress during data collection.  
RAs will be required to have sufficient maturity and background to interact appropriately with ill, aging, stressed 
individuals. The protocol for training of RAs, detailed in our operations manual, addresses enrollment methods 
and the collection of data in a uniform manner.6 Training for RAs in data collection will occur during a two-day 
period prior to beginning subject enrollment. Training will begin with classroom instruction, including the 
purpose and background on each measure, importance of strict adherence to the standardized protocol, step-
by-step instruction for survey administration, criteria for aborting testing and the procedure for audiotaping 
sessions and transmitting data. RAs will be trained to ensure that they do not prompt subjects with verbal or 
nonverbal cues. Training will include practice administering all tests. Consistency in data collection procedures 
will be assessed and reinforced during routine staff meetings. Retraining and retesting will be done 
immediately if a new RA is hired and annually thereafter. The PI and the Project Manager will meet weekly or 
bi-weekly with staff (in-person or by video) to discuss issues of enrollment and data collection. All decisions will 
be logged and filed for future reference. All issues will be reported immediately to the IRB and the Data Safety 
Monitoring Board, as discussed in that plan. 
We will be enrolling a sample of stressed individuals and it is possible that we will identify someone with severe 
distress. We have a previously tested detailed safety plan (Riegel R01HL084394), which has been refined for 
use in this study. This safety plan addresses the concerns associated with severe stress that need to be 
handled in order to ensure that the research participants’ needs are addressed. This plan includes the 
requirement that research staff undergo training in this safety protocol and participate in ongoing regular 
supervision by Dr. Riegel on these procedures. In addition, for participants randomized to the ViCCY group, 
specific rules to ensure privacy and safety will be discussed in the first session, such as being in a private 
place during sessions and not engaging in discussions while driving.  
Confidentiality. To protect against any risk to subject confidentiality, all printed data forms will be coded with 
unique identifiers. The unique identification number will be kept separate from the files with protected health 
information (PHI) to protect subject confidentiality. Every effort will be made to prevent anyone who is not on 
the research team from knowing what information was collected from a particular subject. As part of the 
consent process, subjects will be made aware of the fact that there are some circumstances where the 
research team may have to provide subject information to other people (regulatory or legal circumstances). In 
addition, as we are unable to ensure total Internet security, this limitation of privacy will be noted in the 
informed consent. In this manner caregivers will be informed that although it is highly unlikely that anyone 
would access an audiotaped session, the prevention of such intrusions cannot be guaranteed. The content of 
the intervention sessions is not anticipated to be confidential in nature. 
Data Storage. Since this data storage system is behind multiple firewalls, is monitored regularly, and is 
accessible only to key personnel who receive private network/firewall, server/password, and data directory 
access rights, the risk of unlawful penetration is not a significant data safeguard concern. Individually 
identifiable or deducible data will not be transmitted by unsecured telecommunications, which include the 
Contact PD/PI: RIEGEL, BARBARA J
Protection of Human Subjects                                                                                  
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Internet, email, and electronic File Transfer Protocol (FTP). Further, the data will not be physically moved or 
transmitted in any way from the server without written approval from the project manager. All output containing 
individual identifiable information is treated as confidential data. This information is never transferred 
electronically via email or other protocols. 
All data will be backed up daily and system backups will be done weekly. Batch validity checks will be run on 
the database at periodic intervals to identify data that violate predefined rules. Data will be de-identified and 
stored on the database server with strong access controls, software firewall, secure file transfer protocols, 
network-wide virus protection software, and daily back-ups. The computers will be password-protected and 
maintained in a secure, locked location at the School of Nursing. Interim checks will be conducted regularly to 
ensure that data collection and archiving procedures are operating correctly and security and confidentiality are 
not compromised. All information obtained on paper (e.g., consent forms) will be numerically coded and locked 
in a secure location, as described further below. 
Signed consent forms and other subject-specific information containing names will be kept separate from the 
subject identification numbers. The master list and subject information will be stored in different locked file 
cabinets in the PI’s research offices at the University of Pennsylvania, School of Nursing. Access to these 
master files will be limited to those directly involved in the study. 
Data will be compiled from all of the subjects in the study and aggregated for analysis and publication. All 
identifying data will be eliminated from files before data are electronically transferred to the biostatistician. As a 
result of aggregation, no individual subjects will be identifiable from the written materials. Audiotaped 
interviews will be assigned a unique identifier; any identifiable information in the interviews will be deleted 
during the transcription process. 
Potential Benefits of the Proposed Research to Human Subjects and Others 
We cannot guarantee that any participant will benefit by participating in this study, although all of the 
caregivers will receive health information. We acknowledge that subject burden may be an issue for these 
already-burdened caregivers. However, we believe that the benefits of the knowledge gained will outweigh the 
burden and the risks to participants. A Data and Safety Monitoring Board will be used to ensure the validity and 
integrity of the data. We anticipate that the results of this study will benefit society most, by helping to improve 
the support provided to caregivers of HF patients. It is our judgment that benefits outweigh the risk to study 
participants.  
Importance of the knowledge to be gained  
Heart failure is extremely common in the aging population worldwide. The vast majority of these patients are 
limited functionally and living at home with care provided to them by their loved ones. Little attention has been 
given to these caregivers. This study has the potential to address this underserved and distressed segment of 
the population by improving their abilities to cope with the stress of providing daily care to a loved one with a 
severe, debilitating, and chronic illness and refocus their attentions onto themselves (self-care). If perceived 
stress decreases in caregivers and they are able to care for themselves more effectively, this study will provide 
a new and innovative way to increase the support available for these caregivers.  
ClinicalTrials.gov Requirement 
We will register the trial with Clinical Trials.gov Protocol Registration System no later than 21 days after the 
first subject is enrolled. 
 
CITATIONS 
1. 
Boise L. Health Self-Care Neglect Scale. Empowering family caregivers: The powerful tools for 
caregiving program. Educational Gerontology, 31, 573-586.2005. 
2. 
National Academies of Sciences E, and Medicine,. Families Caring for an Aging America. Washington, 
DC: The National Academies Press; 2016. 
3. 
Luttik ML, Jaarsma T, Tijssen JG, et al. The objective burden in partners of heart failure patients; 
development and initial validation of the Dutch Objective Burden Inventory. Eur J Cardiovasc Nurs. 
2008;7(1):3-9. 
4. 
Makdessi A, Harkness K, Luttik ML, McKelvie RS. The Dutch Objective Burden Inventory: validity and 
reliability in a Canadian population of caregivers for people with heart failure. Eur J Cardiovasc Nurs. 
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Protection of Human Subjects                                                                                  
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Protection of Human Subjects                                                                                  
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