Recruiting

ViCCY

Sponsor:

Visiting Nurse Service of New York

Code:

NCT07220798

Conditions

Heart Failure

Cognitive Impairment

Caregiver Burden

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ViCCY

Study Details

Brief summary:

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.

Conditions

Heart Failure

Cognitive Impairment

Caregiver Burden

Study ID

NCT07220798

Start date

May 28, 2026

Status verified date

Aug, 2026

Completion date

Apr 28, 2030

Anticipated

Primary completion date

Apr 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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/child or other informal caregiver 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

Enrollment

316 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: ViCCY Intervention

The intervention group will receive 10 sessions of ViCCY over 6-months.

no intervention: Usual Care

Usual Home Health Care.

Interventions

ViCCY

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

VNS Health

Recruiting

New York, New York, United States, 10017

Contacts

Barbara Riegel, PhD, RN, FAHA, FAAN

215.898.9927briegel@nursing.upenn.edu

Principal Investigator:

Barbara Riegel, PhD, RN, FAHA, FAAN

More Information

Sponsor

Visiting Nurse Service of New York

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • heart failure
  • cognitive impairment
  • caregiver burden
  • caregiver stress
  • self-care
  • dyads

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Visiting Nurse Service of New York on 2026-08-12.