18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in the Health Self-Care Neglect (HSCN) ScalePrimary· The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
The Health Self-Care Neglect (HSCN) scale measures an individual's neglect of self-care behaviors. It consists of 9 yes or no questions. Scores range from 0-9. Higher scores indicating more self-care neglect.
HSCN Baseline Score
Group
Value
95% CI
Intervention
4.89
± 2.07
Control
4.97
± 2.12
HSCN 3 Month Score
Group
Value
95% CI
Intervention
3.09
± 2.07
Control
3.50
± 2.17
HSCN 6 Month Score
Group
Value
95% CI
Intervention
2.67
± 2.09
Control
3.49
± 2.16
HSCN 9 Month Score
Group
Value
95% CI
Intervention
2.34
± 1.99
Control
3.02
± 2.24
HSCN 12 Month Score
Group
Value
95% CI
Intervention
2.57
± 2.10
Control
3.09
± 2.17
Change in the Self-Care Inventory, Maintenance ScalePrimary· The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
The Self-Care Inventory is a 20 item inventory with 3 embedded scales (self-care maintenance, monitoring, and management). The outcome used in this study was the 8-item Self-Care Maintenance Scale. Responses are added and standardized to range from 0-100. A higher score indicates better self-care.
Self Care Maintenance, Baseline Score
Group
Value
95% CI
Intervention
68.83
± 16.09
Control
68.15
± 15.73
Self Care Maintenance, 6 Month Score
Group
Value
95% CI
Intervention
79.86
± 12.29
Control
72.85
± 12.35
Self Care Maintenance, 12 Month Score
Group
Value
95% CI
Intervention
76.62
± 13.26
Control
74.58
± 14.61
Change in the Perceived Stress Scale (PSS)Secondary· Main analysis was Baseline to 6 months. Data will be analyzed at 12 months to determine sustainability of intervention effect.
The Perceived Stress Scale (PSS), a 14-item instrument that provides a global rating of an individual's belief in the severity and frequency of stressful experiences during the last month. The Perceived Stress Scale includes 14 items designed to assess symptoms of stress and global measures of the degree of stress experienced in the past month. Each item is scored from 0 (never) to 4 (very often), with total sum scores ranging from 0 to 56; higher scores indicate higher perceived stress. In prior test, Cronbach's alpha of the scale ranged from 0.84 to 0.86, and was 0.91 for older African Ameri
PSS Baseline Score
Group
Value
95% CI
Intervention
25.91
± 7.48
Control
26.49
± 7.73
PSS 6 Month Score
Group
Value
95% CI
Intervention
19.73
± 6.97
Control
25.20
± 8.71
PSS 12 Month Score
Group
Value
95% CI
Intervention
20.76
± 8.39
Control
24.00
± 9.02
Change in the Ways of Coping QuestionnaireSecondary· The primary analysis was at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
We used a 30-item modification of the original 42-item questionnaire developed by Lazarus in 1985. We measured these coping styles: active, avoidance, and minimization. The instrument uses a 4-point Likert-scale response format (0 = not used to 3 = used a great deal). Scores range from 0-45, 0-30, and 0-30 for the active, avoidance and minimization subscales, respectively. Higher scores indicate greater use of particular coping styles.
Avoidance Coping Baseline Score
Group
Value
95% CI
Intervention
9.04
± 5.86
Control
10.72
± 6.37
Avoidance Coping 3 Month Score
Group
Value
95% CI
Intervention
8.95
± 5.72
Control
9.01
± 6.22
Avoidance Coping 6 Month Score
Group
Value
95% CI
Intervention
8.82
± 5.86
Control
11.85
± 6.18
Avoidance Coping 9 Month Score
Group
Value
95% CI
Intervention
9.84
± 5.73
Control
10.89
± 6.83
Avoidance Coping 12 Month Score
Group
Value
95% CI
Intervention
8.61
± 6.32
Control
10.54
± 6.10
Active Coping Baseline Score
Group
Value
95% CI
Intervention
22.56
± 9.14
Control
22.92
± 10.29
Active Coping 3 Month Score
Group
Value
95% CI
Intervention
24.88
± 8.95
Control
21.52
± 10.06
Active Coping 6 Month Score
Group
Value
95% CI
Intervention
27.36
± 9.54
Control
25.50
± 10.66
Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)Secondary· Main analysis Baseline to 6 months. Sustainability assessed at 12 months.
Medical Outcomes Study Short Form (SF-36): measure of physical and mental health.The SF-36 has 36 items formatted in scales of varied format (3-, 5- and 6-pt scales and dichotomous \[yes/no\] scales). Each component score is standardized a 0-100 point scale. Higher values represent better health status. Reliability is varied samples is typically 0.80. Convergent and divergent validity have been demonstrated in various populations, including caregivers. A benefit of using the SF-36 is that it is one of the common data elements.
SF36 Physical Component Baseline Score
Group
Value
95% CI
Intervention
48.02
± 10.11
Control
47.25
± 9.57
SF36 Physical Component 6 Month Score
Group
Value
95% CI
Intervention
47.84
± 9.84
Control
48.18
± 9.52
SF36 Physical Component 12 Month Score
Group
Value
95% CI
Intervention
49.10
± 9.33
Control
47.57
± 10.95
SF36 Mental Component Baseline Score
Group
Value
95% CI
Intervention
43.17
± 12.27
Control
41.06
± 12.21
SF36 Mental Component 6 Month Score
Group
Value
95% CI
Intervention
48.18
± 10.43
Control
42.73
± 12.10
SF36 Mental Component 12 Month Score
Group
Value
95% CI
Intervention
46.87
± 11.27
Control
44.33
± 11.78
Change in the Caregivers' SF-6D (Short Form Six-dimension) ScoresSecondary· Measured at baseline, 3, 6, 9, and 12 months; primary analysis baseline to 12 months
The SF-6D uses preference weights derived from the SF-36. The Short-Form Six-Dimension (SF-6D) provides a way to use the SF-36 in economic evaluation by estimating a preference-based single index measure for health from these data using general population values. The SF-6D score represents caregiver quality of life at a given timepoint. Higher SF-6D Scores are better.
Baseline SF-6D
Group
Value
95% CI
Intervention
0.696
± 0.105
Control
0.675
± 0.132
6 Month SF-6D
Group
Value
95% CI
Intervention
0.733
± 0.119
Control
0.688
± 0.128
12 Month SF-6D
Group
Value
95% CI
Intervention
0.731
± 0.107
Control
0.690
± 0.116
Difference in Caregivers' Hospital and Provider EventsSecondary· Data were collected at Baseline, 3, 6, 9, and 12 months. The primary analysis was done using the baseline to 12 month period.
Healthcare resource use was self-reported by caregivers when they were telephoned at each follow-up period, asking about utilization since the last interview date. The self-reported healthcare use comprised 5 major categories: hospitalizations, emergency department (ED) visits, diagnostic and therapeutic procedures, ambulance services, and home care services. A bottom-up cost account approach was used, wherein the sum of resources times their unit price yielded the total costs associated with healthcare resource use. Unit prices were measured using the 2021 Medical Expenditure Panel Survey (ME
Healthcare Cost 0-1 Month
Group
Value
95% CI
Intervention
59.703
± 281.566
Control
67.004
± 379.774
Healthcare Cost 0-3 Month
Group
Value
95% CI
Intervention
247.539
± 1223.542
Control
955.193
± 4262.877
Healthcare Cost 0-6 Month
Group
Value
95% CI
Intervention
1155.871
± 2577.653
Control
1585.167
± 5448.238
Healthcare Cost 0-9 Month
Group
Value
95% CI
Intervention
1347.139
± 3018.211
Control
2007.453
± 6889.446
Healthcare Cost 0-12 Month
Group
Value
95% CI
Intervention
1811.245
± 3228.807
Control
3121.488
± 8123.811
Difference in Patient Hospitalization RateSecondary· Count of patient hospitalizations that occurred between 6 and 12 months (following the intervention, which ended at 6 months)
For the 93 patients enrolled, the medical record was reviewed to capture hospitalization count. The aim was to explore the effect of caregiver outcomes (self-care) on HF patient outcomes. We hypothesize that at 12 months, HF patients whose caregivers improve vs. not improve in self-care (regardless of treatment group) will have Lower hospitalization rates. A comparison of patients' hospitalization counts which occurred between 6 and 12 month timepoints was conducted between those caregivers who exhibited a self care improvement from baseline to 6 month timepoint and those caregivers who did no
Group
Value
95% CI
Enrolled Patients With Caregivers Who Improved in Self Care
0.40
± 0.89
Enrolled Patients With Caregivers Who Did Not Improve in Self Care
0.31
± 0.62
Patient Hospitalization DaysSecondary· Count of patient hospitalization days which occurred between 6 and 12 month timepoints
For the 93 patients enrolled, the medical record was reviewed to capture hospitalization days. The aim was 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 treatment group) will have Lower hospitalization rates. A comparison of patients' hospitalization days which occurred between 6 and 12 month timepoints was conducted between those caregivers who exhibited a self care improvement from baseline to 6 month timepoint and
Group
Value
95% CI
Patients of Caregivers Who Exhibited Improvement in Self Care
3.85
± 8.71
Patients of Caregivers Who Did Not Exhibit Improvement in Self Care
3.04
± 12.16
Patient Mortality RatesSecondary· Patient mortality occurring between months 6-12 of the study (following the intervention period)
For the 93 patients enrolled, the medical record was reviewed to measure mortality. The aim was 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 treatment group) would have lower mortality rates. A comparison of patient mortality occurring between 6 and 12 months was conducted between those caregivers who improved in self care during the intervention period (baseline to 6 months) and those caregivers who did not improve
Group
Value
95% CI
Patients of Caregivers Who Exhibited Improvement in Self Care
47
Patients of Caregivers Who Did Not Exhibit Improvement in Self Care
26
Patients of Caregivers Who Exhibited Improvement in Self Care
1
Patients of Caregivers Who Did Not Exhibit Improvement in Self Care
0
Change in the Patients' Quality Adjusted Life Years (QALYs) Measured With the SF-6D (Short Form Six-dimension) Derived From the Short Form-36Secondary· QALYs were measured at baseline, 3, 6, 9, and 12 months. But this analysis focused on the baseline to 12 month period.
This measure of quality adjusted life years (QALY) is derived from the SF-36. It was used in the cost-effectiveness analysis. The SF-6D uses preference weights derived from the SF-36. The Short-Form Six-Dimension (SF-6D) provides a way to use the SF-36 in economic evaluation by estimating a preference-based single index measure for health from these data using general population values. The SF-6D score represents patient quality of life at a given timepoint, while the QALY represents the area under the curve of patient quality of life from baseline to 12-month timepoints. A QALY value of one e
Group
Value
95% CI
Enrolled Patients With Caregivers Who Exhibited Improvement in Self Care
0.67
± 0.11
Enrolled Patients With Caregivers Who Did Not Improve in Self Care
0.68
± 0.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected from enrolled caregivers at baseline, 3-month, 6-month, 9-month, and 12-month study timepoints..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Informal caregiving is demanding and stressful. Caregivers of adults with heart failure (HF) report significant stress and poor self-care. Health coaching, a support intervention, may relieve stress and promote self-care in HF caregivers. Few studies have tested the cost-effectiveness of support interventions for caregivers. Even less is known about the effect of caregiver support interventions on HF outcomes. We developed and tested a virtual support intervention (ViCCY ("Vicky")-Virtual Caregiver Coach for you), in HF caregivers. Using randomized controlled trial (RCT) design, we enrolled 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 received Health Information (HI) delivered through the Internet, but the ViCCY caregiver group also received 10 health coaching support sessions tailored to individual issues. The control group had 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 collected self-reported data on self-care, stress, coping, and health status. At 6 months, we compared ViCCY to HI alone to assess intervention efficacy using intent-to-treat analysis. A sample of 250 caregivers (125/arm) was enrolled to provide \>90% power to detect significant differences between the groups on the primary outcome of self-care (Aim 1). We collected 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 would enroll, we consented a subgroup of 93 HF patients cared for by these caregivers to explore the effect of caregiver self-care on patient outcomes. 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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
Last refreshed: 20 February 2025
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