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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-101
SponsorVisiting Nurse Service of New York

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient Inclusion Criteria

Older adults (=>50 years of age)

Enrolled in Home Health Care

Documented to have HF

Disqualifiers

Patient Exclusion Criteria

Dementia (ICD-10 code for dementia)

Enrolled in hospice

Non-English speaking

Trial design

Design model

Parallel

Treatments tested in this trial

  • ViCCY

    Behavioral

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

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: ViCCY InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline, 3- and 6- and 12-months

Secondary outcomes

1

Self-Care of Informal Caregiver Inventory (Caregiver)

Behaviors performed to maintain health

Time frame
Baseline, 3- and 6- and 12-months
2

Perceived Stress Scale short form (Caregiver)

Demands exceed ability to cope

Time frame
Baseline, 3- and 6- and 12-months
3

Brief-COPE (Caregiver)

Ability to respond to stressors with appropriate adaptive coping resources.

Time frame
Baseline, 3- and 6- and 12-months
4

Dyadic Relationship Scale (Both)

Measure of strain in the dyadic relationship

Time frame
Baseline, 3- and 6- and 12-months

Other outcomes

Sponsors and contacts

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Visiting Nurse Service of New York

Lead sponsor

University of Pennsylvania

Collaborator