Virtual Caregiver Coach for You (ViCCY)

Visiting Nurse Service of New York

Status: Begins enrollment in 4 months

Conditions: Cognitive Impairment; Caregiver Burden; Heart Failure

Treatments: Behavioral: ViCCY

Study type: Interventional

Funder types: Other

Identifiers

NCT07220798

1R01AG094822 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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 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.

Participant Recruitment and Data Collection

Participants will be (254) 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.

Enrollment: 314 estimated patients

Sex: All

Ages: 18 to 101 years old

Volunteers: No Healthy Volunteers

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 or child 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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314 participants in 2 patient groups

ViCCY Intervention

Experimental group

Description:

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

Treatment:

Behavioral: ViCCY

Usual Care

No Intervention group

Description:

Usual Home Health Care.