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

Part of paid clinical trials in New York, New York.

Sponsor
Visiting Nurse Service of New York
Study ID
NCT07220798
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 101 Years
Healthy Volunteers
Not accepted

Interventions

  • ViCCY — BEHAVIORAL
    The intervention group will receive 10 Health Coach sessions of ViCCY over 6-months.

Study Details

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.

Key Dates

First listed
Oct 24, 2025
Start date
May 28, 2026
Status verified
Aug 2026
Primary completion
Apr 28, 2030
Completion
Apr 28, 2030

Study Design

Enrollment
316 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: ViCCY Intervention
    The intervention group will receive 10 sessions of ViCCY over 6-months.
  • No Intervention: Usual Care
    Usual Home Health Care.

Primary Outcome Measure

Short Form Health Survey (SF-36) (Both) [ Time Frame: Baseline, 3- and 6- and 12-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VNS HealthNew YorkNew York10017
Barbara Riegel, PhD, RN, FAHA, FAAN
[email protected]
215.898.9927
Nicole Onorato, MPH
[email protected]
2126095770
Barbara Riegel, PhD, RN, FAHA, FAAN (PRINCIPAL_INVESTIGATOR)

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By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
VNS Health· New York, NY

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