Virtual Caregiver Coach for You (ViCCY)

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Cognitive Impairment; Caregiver Burden

• Registration Number: NCT07220798
• Lead Sponsor: Visiting Nurse Service of New York

Brief 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.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-22
• Study First Submitted QC: 2025-10-22
• Study First Posted: 2025-10-24
• Last Update Submitted: 2025-10-24
• Last Update Posted: 2025-10-28
• Study Start: 2026-06-15
• Primary Completion: 2028-06-14
• Study Completion: 2029-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

• Patient Inclusion Criteria

  1. Older adults (=>50 years of age)
  2. Enrolled in Home Health Care
  3. Documented to have HF
  4. Mild to moderate CI on the BIMS or OASIS items
  5. Able to provide informed consent
  6. Able to provide self-report data

• Caregiver Inclusion Criteria

  1. Adults (=>18 years of age)
  2. Spouse/partner or child living with or in close proximity to the patient
  3. Caregiver of a home care patient who is currently receiving or recently received services and who has mild to severe cognitive impairment
  4. Reporting poor self-care on screening (Health Self-Care Neglect scale score =>2)
  5. Reporting poor mental health on screening (screened with the PROMIS Global Mental Health 4a score <12)
  6. Caregiving or supporting the patient at least 8 hours/week
  7. Able to complete the protocol, e.g., adequate vision and hearing, English speaking.
  8. Able to provide informed consent
  9. Able to use technology

Exclusion Criteria

• Patient Exclusion Criteria

  1. Dementia (ICD-10 code for dementia)
  2. Enrolled in hospice
  3. Non-English speaking

• Caregiver Exclusion Criteria 1. Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Short Form Health Survey (SF-36) (Both)	Baseline, 3- and 6- and 12-months	Mental health is a state of mental well-being that enables people to cope with the stresses of life, realize their abilities, learn well and work well. The SF-36 provides standardized scores and national norms for comparison. The SF-36 is valid in many populations and caregivers. It is one of the common data elements.

Secondary Outcome Measures

Name	Time	Method
Self-Care of Informal Caregiver Inventory (Caregiver)	Baseline, 3- and 6- and 12-months	Behaviors performed to maintain health
Perceived Stress Scale short form (Caregiver)	Baseline, 3- and 6- and 12-months	Demands exceed ability to cope
Brief-COPE (Caregiver)	Baseline, 3- and 6- and 12-months	Ability to respond to stressors with appropriate adaptive coping resources.
Dyadic Relationship Scale (Both)	Baseline, 3- and 6- and 12-months	Measure of strain in the dyadic relationship
HF Caregiver Questionnaire (Patient)	Baseline, 3- and 6- and 12-months	load experienced when caring for a loved one
Patient Health Questionnaire (PHQ-9) (Patient)	Baseline and 6-months	Measures signs and symptoms of depression.
Generalized Anxiety Disorder (GAD-7) (Patient)	Baseline and 6-months	Measures signs and symptoms of Anxiety.
HF Somatic Perception Scale (Patient)	Baseline and 6-months	Measures symptoms of Heart Failure.
Charlson Comorbidity Index (Patient)	Baseline and 6-months.	Captures patient Medications and Chronic Conditions.