An interventional study of ViCCY in Heart Failure, Cognitive Impairment and Caregiver Burden, sponsored by Visiting Nurse Service of New York. Recruiting at 1 site in United States. Open to participants aged 18 Years to 101 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Visiting Nurse Service of New York · Not applicable, Interventional, and Health services research
This RCT design will enroll 256 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.
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 256 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 (256) 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.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 316 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Visiting Nurse Service of New York is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Patient Inclusion Criteria
Caregiver Inclusion Criteria
Exclusion Criteria:
Patient Exclusion Criteria
The intervention group will receive 10 sessions of ViCCY over 6-months.
Behavioral: ViCCY
Usual Home Health Care.
The intervention group will receive 10 Health Coach sessions of ViCCY over 6-months.
Short Form Health Survey (SF-36) (Both)
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.
Time frame: Baseline, 3- and 6- and 12-months
Self-Care of Informal Caregiver Inventory (Caregiver)
Behaviors performed to maintain health
Time frame: Baseline, 3- and 6- and 12-months
Perceived Stress Scale short form (Caregiver)
Demands exceed ability to cope
Time frame: Baseline, 3- and 6- and 12-months
Brief-COPE (Caregiver)
Ability to respond to stressors with appropriate adaptive coping resources.
Time frame: Baseline, 3- and 6- and 12-months
Dyadic Relationship Scale (Both)
Measure of strain in the dyadic relationship
Time frame: Baseline, 3- and 6- and 12-months
HF Caregiver Questionnaire (Patient)
load experienced when caring for a loved one
Time frame: Baseline, 3- and 6- and 12-months
Patient Health Questionnaire (PHQ-9) (Patient)
Measures signs and symptoms of depression.
Time frame: Baseline and 6-months
Generalized Anxiety Disorder (GAD-7) (Patient)
Measures signs and symptoms of Anxiety.
Time frame: Baseline and 6-months
HF Somatic Perception Scale (Patient)
Measures symptoms of Heart Failure.
Time frame: Baseline and 6-months
Charlson Comorbidity Index (Patient)
Captures patient Medications and Chronic Conditions.
Time frame: Baseline and 6-months.
Plan to share: No
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Visiting Nurse Service of New York