DOI: 10.3886/icpsr39524.v1
title: Improving Self-Care of Informal Caregivers of Adults with Heart Failure, United States, 2019-2024
title: Version 1

description: This randomized controlled trial tested the efficacy of a virtual support health coaching intervention compared to a health information control group in improving self-care, decreasing stress, and improving coping and health status of informal caregivers of adults with heart failure. A secondary aim was to estimate intervention cost and cost-effectiveness. An exploratory aim was to explore the effect of caregiver outcomes on patient outcomes.
description: Data were collected at baseline and 3 and 6 months. The 3-month session was intended to keep participants engaged in the study, and they only completed one of the primary outcome measures of self-care during that brief contact. Self-care was assessed with the maintenance scale of the self-care inventory (SCI) and the Health Self-Care Neglect (HSCN) scale. These 2 measures are related, but they do not measure the same construct, as self-care reflects a priority given to specific behaviors, while neglecting self-care reflects a choice that may be intentional or due to deprioritizing one's own health while caregiving. Higher self-care maintenance scale scores indicate improvement in health-promoting behaviors. Lower HSCN scale scores indicate less neglect of oneself. Secondary outcomes assessed were perceived stress, coping, and health status. Perceived stress was assessed with the perceived stress scale, with scores ranging from 0 to 40 and higher scores indicating higher perceived stress. Scores between 0 and 13 are considered low stress, scores between 14 and 26 reflect moderate stress, and scores between 27 and 40 reflect high perceived stress. Coping was assessed with the ways of coping questionnaire, short-form, with scales measuring active, avoidance, and minimization coping. Increasing active coping scores and decreasing avoidance and minimization coping scores indicate improvement. Health status was assessed with the original short-form 36 scale. Increasing short-form 36 scores indicates improvement. In addition to these measures, caregiver burden, sociodemographic, and clinical characteristics were assessed at baseline and used to describe the sample of caregivers. A half SD change was considered clinically relevant for all scores. Patients' sociodemographic and clinical information was collected from the medical record.
description: Response Rates: A total of 667 caregivers were assessed for eligibility;
250 were enrolled and randomized to the ViCCY intervention
(n=125) or the control group (n=125).
The primary reasons for ineligibility were a HSCN (Health Self-Care Neglect) scale score that was too low (n=124); the caregiver was not supporting
the patient &gt;= 8 hours each week (n=21) or discomfort
with technology (n=13). Those who were eligible
and declined to participate commonly felt that the intervention
was too time-consuming (n=123) or said that
they did not feel the need for support (n=87). Of those
enrolled and assigned to the intervention group, completion
rates varied (mean, 6 +/- 4 sessions; median, 9; 21%
did not complete any formal sessions).
Attrition was 22%, with 56 caregivers withdrawing
from the study within 6 months. In the intervention
group, 25% withdrew or were lost to follow-up. In the
control group, 20% withdrew or were lost to follow-up.
description: Presence of Common Scales: 
Self-Care Inventory (SCI)
Health Self-Care Neglect Scale (HSCN)
Telephone Interview for Cognitive Status (TICS)
description: Caregivers were enrolled primarily from the Heart and Vascular Center, clinical practices, and the acute care hospital affiliated with a major regional referral center in the northeastern United States. The COVID pandemic began during the first year of the study. Recruitment occurred in person before the pandemic began, but, afterward, recruitment was predominately virtual using monthly information sessions offered to caregivers referred by clinical staff. In-person enrollment resumed 4 months into the pandemic although access to caregivers was limited for ~1 year. The Project Manager and Clinical Research Coordinator screened caregivers and enrolled all study participants. 
A biostatistician independent of the study investigators generated the randomization sequence using a randomly permuted blocks algorithm to ensure equal distribution of caregiver sex, relationship to the patient (spouse versus nonspouse), and race (White versus other) in each study arm. After a new participant was fully enrolled and had completed the baseline survey, the project manager accessed sequentially numbered containers to allocate them to the appropriate group. Then, she notified each participant by email to tell them of their group assignment. If the participant was randomized to the intervention group, a health coach was assigned and prompted to initiate contact.
description: Datasets: 
DS1: Improving Self-Care of Informal Caregivers of Adults with Heart Failure, United States, 2019-2024
description: Informal caregivers of adults with heart failure in the United States. Smallest Geographic Unit: United States
description: web-based survey