What is the clinical evidence from this study?

Study design: RCT. Population: Caregivers of persons with heart failure (n=48). Intervention: Caregiver Support Program vs. Waitlist control (usual care). Primary outcome: Change in caregiver quality of life (QOL) from baseline to 16 weeks.

May 5, 2022Open Access

Strengths-building through life purpose, self-care goal setting and social support: Study protocol for Caregiver Support

Q: What does this research mean for the field?

A multicomponent strengths-based Caregiver Support Program is being evaluated in a randomized controlled trial to determine its feasibility and initial effect size for improving quality of life, fatigue, and burden in heart failure caregivers. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Key Result

The Caregiver Support Program is being evaluated in a single-blind, waitlist randomized controlled trial to determine its feasibility and initial effect size for improving quality of life in heart failure caregivers.

Study Design

Type

RCT (n=48)

Blinding

Single-blind

Randomization

Block randomization

Multicenter

Structured PICO

Does the Caregiver Support Program improve quality of life in caregivers of people with heart failure?

Population

48 caregivers (≥ 18 years, English speaking) of people with heart failure who were hospitalized within the last 6 months, providing support for at least 1 IADL and living within a 1 h driving radius of Johns Hopkins Hospital.

Intervention

Caregiver Support Program (a multicomponent strengths-based intervention)

Comparator

Waitlist control group

Outcome

Caregiver quality of life from baseline to 16 weekspatient reported

This study protocol outlines a randomized trial to evaluate whether a strengths-based intervention improves quality of life and reduces burden in caregivers of heart failure patients.

Limitations

The intervention was adapted for virtual implementation due to COVID-19, and evidence for virtual format is limited
Individualized tailoring of goal-setting makes it difficult to establish which aspect of the intervention influences outcomes
The intervention was developed and tested within a single site

Abstract

Background: For caregivers of people with heart failure, addressing a range of care recipient needs at home can potentially be burdensome, but caregivers may also gain meaning from caregiving. The Caregiver Support Program, a multicomponent strengths-based intervention, is designed to improve outcomes of heart failure caregivers. Objectives: 1) Test the feasibility and gauge an initial effect size of the Caregiver Support Program to improve caregiver quality of life (primary outcome), and fatigue and burden (secondary outcomes) from baseline to 16 weeks, 2) test whether fatigue and caregiver burden are associated with objective measures of resilience (sweat inflammatory cytokines (Il-6 and IL-10) and self-reported resilience, 3) evaluate changes in heart rate variability, IL-6 and IL-10, pre- and post-intervention. Methods: This is a single-blind, two group, waitlist control trial. Eligible caregivers are 1) ≥ 18 years, 2) English speaking, 3) live with the person with heart failure or visit them at least 3 days per week to provide care, 4) provide support for at least 1 instrumental activity of daily living (IADL), 5) live within a 1 h driving radius of the Johns Hopkins Hospital, and 6) the care-recipient has been hospitalized within the last 6 months. Trial participants are randomized into the immediate intervention (n = 24) or waitlist control group (n = 24). Data collection is at baseline, 16 weeks, and 32 weeks. Conclusion: The Caregiver Support program has the potential to increase quality of life and decrease fatigue and caregiver burden for caregivers of people with heart failure and multiple co-morbidities.

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