NCT07220798

Virtual Caregiver Coach for You (ViCCY)

Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment (ViCCY)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Visiting Nurse Service of New York · Academic / Other
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

Summary

This RCT design will enroll 254 informal caregivers (spouse/partner or child) of HHC patients with HF/CI and 60 patients with HF and mild to moderate CI (60 dyads). After collecting baseline data, we will block randomize the caregivers 1:1 to the ViCCY intervention or comparator group, stratifying randomization by caregiver sex (male/female), relationship (spouse/partner or child), and race (white/other)- factors known to influence caregiving burden, perceived stress, and receptivity to the intervention. We will encourage caregivers to use their own devices but provide tablet devices with wireless network access if needed. The intervention group will receive 10 sessions of ViCCY over 6 months.

Detailed description

Purpose and Specific Aims Cognitive Impairment (CI) has been reported to be as high as 78% in older adults with Heart Failure (HF). CI markedly increases the risk of adverse HF outcomes such as hospitalization and death, and patients with CI and HF are rarely able to manage without a caregiver. The high level of caregiving demands lead to an increase in stress and strained relationships with caregiving recipients, which can lead to poor coping and decreased mental health among caregivers. This study aims to test a self-care intervention (Virtual Caregiver Coach for You -ViCCY) targeting caregivers to support mental health and explore whether changes in caregiver mental health impacts patient outcomes. We will examine relationship strain as the primary mechanism for improvements in outcomes in patients and caregivers. Aim 1: Test the efficacy of ViCCY vs. UC in improving outcomes of caregivers of home health care (HHC) patients with HF/CI. Aim 2: Explore the effect of ViCCY on outcomes in HHC patients with HF/CI. At 6-months we will report differences in mental health measured with the SF-36 and its contributors of depression, anxiety, and somatic HF symptoms between patients whose caregivers are randomized to ViCCY compared to UC. Aim 3: Describe the mechanisms by which outcomes are achieved. Overview of Study Design and Methods This RCT design will enroll 254 informal caregivers (spouse/partner or child) of HHC patients with HF/CI and 60 patients with HF and mild to moderate CI (60 dyads). After collecting baseline data, we will block randomize the caregivers 1:1 to the ViCCY intervention or comparator group, stratifying randomization by caregiver sex (male/female), relationship (spouse/partner or child), and race (white/other)- factors known to influence caregiving burden, perceived stress, and receptivity to the intervention. We will encourage caregivers to use their own devices but provide tablet devices with wireless network access if needed. The intervention group will receive 10 sessions of ViCCY over 6 months. Participant Recruitment and Data Collection Participants will be (254) caregivers of community dwelling older adults with HF/CI and 60 dyads (caregivers and patients) with HF and mild to moderate CI. Data Sources and Analysis We will use an intent-to-treat approach with the primary outcomes assessed at baseline, 3- and 6-months, and 12-months. Efficacy will be analyzed at 6-months. We will summarize participant characteristics using descriptive statistics. Shapiro-Wilk and Levin's tests will be used to assess distributional assumptions of normality. Mixed effects regression models will be used to assess intervention efficacy. Outcomes will be assessed using pre-post self-reported survey data.

Conditions

• Heart Failure
• Cognitive Impairment
• Caregiver Burden

Interventions

Type	Name	Description
BEHAVIORAL	ViCCY	The intervention group will receive 10 Health Coach sessions of ViCCY over 6-months.

Timeline

• Start date: 2026-06-15
• Primary completion: 2028-06-14
• Completion: 2029-09-15
• First posted: 2025-10-24
• Last updated: 2025-10-28