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

NCT07220798 | Not Yet Recruiting DMC

• 1 other identifier: 1R01AG094822
• Study Type: interventional
• Target: 314
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Cognitive Impairment; Caregiver Burden

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3- and 6- and 12-months

Secondary Outcomes (9)

• Self-Care of Informal Caregiver Inventory (Caregiver)

  Baseline, 3- and 6- and 12-months

• Perceived Stress Scale short form (Caregiver)

  Baseline, 3- and 6- and 12-months

• Brief-COPE (Caregiver)

  Baseline, 3- and 6- and 12-months

• Dyadic Relationship Scale (Both)

  Baseline, 3- and 6- and 12-months

• HF Caregiver Questionnaire (Patient)

  Baseline, 3- and 6- and 12-months

Study Arms (2)

ViCCY Intervention

EXPERIMENTAL

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

Behavioral: ViCCY

Usual Care

NO INTERVENTION

Usual Home Health Care.

Interventions

ViCCY BEHAVIORAL

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

ViCCY Intervention

Eligibility Criteria

• Age: 18 Years - 101 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults (=\>50 years of age)
• Enrolled in Home Health Care
• Documented to have HF
• Mild to moderate CI on the BIMS or OASIS items
• Able to provide informed consent
• Able to provide self-report data
• Adults (=\>18 years of age)
• Spouse/partner or child living with or in close proximity to the patient
• Caregiver of a home care patient who is currently receiving or recently received services and who has mild to severe cognitive impairment
• Reporting poor self-care on screening (Health Self-Care Neglect scale score =\>2)
• Reporting poor mental health on screening (screened with the PROMIS Global Mental Health 4a score \<12)
• Caregiving or supporting the patient at least 8 hours/week
• Able to complete the protocol, e.g., adequate vision and hearing, English speaking.
• Able to provide informed consent
• Able to use technology

You may not qualify if:

• Dementia (ICD-10 code for dementia)
• Enrolled in hospice
• Non-English speaking

Sponsors & Collaborators

• Visiting Nurse Service of New York: lead
• University of Pennsylvania: collaborator

MeSH Terms

Conditions

Heart Failure; Cognitive Dysfunction; Caregiver Burden

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Barbara Riegel, PhD, RN

  VNS Health (formerly Visiting Nurse Service of New York)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Riegel, PhD, RN

CONTACT

215.898.9927; briegel@nursing.upenn.edu

Nicole Onorato, MPH

CONTACT

212-609-5770; Nicole.Onorato@vnshealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and all staff involved in collecting assessment data will be blinded to group assignment until after the data are locked. The coach providing the intervention, Dr. Hirschman (fidelity), and the caregiver participants will not be blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is based on both the Transactional Model of Stress and Coping and the Dyadic Health Behavior Change model. The stressor for caregivers is the demand of caregiving. This stressor commonly causes stress in the relationship. The response to this stressor is influenced by appraisal of the stress, resources, problem management, and support resources, factors used in the ViCCY intervention. In patients, caregiver stress, combined with the stress of illness, accentuates cognitive, affective, and somatic symptoms, thereby impairing mental health. Interdependence is captured in the Dyadic Health Behavior Change model, which emphasizes the individual contributions of both the patient and the caregiver while simultaneously recognizing the synergy of the relationship.

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 24, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 14, 2028
• Study Completion (Estimated): September 15, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share