CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 343 enrolled
Drug / intervention
ViCCYbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03988621
NCT03988621Phase 2Completed

Improving Self-Care of Informal Caregivers of Adults With Heart Failure

University of Pennsylvania·interventional·Posted Jun 17, 2019·Updated Feb 20, 2025

In Brief

A Phase 2 clinical trial evaluating ViCCY for Heart Failure. Completed, enrolled 343 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 17, 2019
Enrollment StartAug 23, 2019
Primary CompletionApr 19, 2023
Study CompletionOct 19, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.0 years ago

Interventions

ViCCYbehavioral

Virtual Caregiver Coach for You