Improving Self-care of Heart Failure Caregivers

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-23

Study Completion Date

2023-10-19

Brief Summary

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Informal caregiving is demanding and stressful. Caregivers of adults with heart failure (HF) report significant stress and poor self-care. Health coaching, a support intervention, may relieve stress and promote self-care in HF caregivers. Few studies have tested the cost-effectiveness of support interventions for caregivers. Even less is known about the effect of caregiver support interventions on HF outcomes. We developed and tested a virtual support intervention (ViCCY ("Vicky")-Virtual Caregiver Coach for you), in HF caregivers. Using randomized controlled trial (RCT) design, we enrolled informal HF caregivers with poor self-care (Health Self-Care Neglect scale score\>=2), randomizing them 1:1 to an intervention or control group. Both groups received Health Information (HI) delivered through the Internet, but the ViCCY caregiver group also received 10 health coaching support sessions tailored to individual issues. The control group had access to the same HI resources over the same interval, using the same Internet program, but without coaching support. At baseline and 3, 6, 9, and 12 months, we collected self-reported data on self-care, stress, coping, and health status. At 6 months, we compared ViCCY to HI alone to assess intervention efficacy using intent-to-treat analysis. A sample of 250 caregivers (125/arm) was enrolled to provide \>90% power to detect significant differences between the groups on the primary outcome of self-care (Aim 1). We collected quality adjusted life years (QALYs) and health care resource use in caregivers over 12 months to assess cost-effectiveness of ViCCY (Aim 2). To explore the effect of caregiver outcomes on HF patients' outcomes (hospitalization rates, hospital days, mortality rates, QALYs) over a 12-month period (Aim 3) and knowing that not all HF patients would enroll, we consented a subgroup of 93 HF patients cared for by these caregivers to explore the effect of caregiver self-care on patient outcomes. If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily scaled to support millions of caregivers worldwide. This application addresses the NINR strategic plan and is directly responsive to PA-18-150.

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Detailed Description

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We used a randomized controlled trial (RCT) design, randomizing informal heart failure (HF) caregivers meeting our inclusion and exclusion criteria 1:1 to an intervention or control group. After collecting baseline data, we block randomized the caregivers to achieve equal distribution of key variables in each condition. We will block randomize on caregiver sex (male/female), relationship to patient (e.g., spouse), and race. Sex and relationship are factors known to influence perceived caregiving burden and receptivity to intervention. Race was included to assure group balance. The randomization sequence was generated a priori by a statistician independent of the study investigators using a randomly permuted blocks algorithm to ensure equal distribution of these variables in each study arm. The Project Manager notified study staff and participants of their group assignment (intervention or control) by telephone, email or message, as preferred by the individual. Investigators and all staff involved in collecting assessment data were blinded to group assignment until after the data were locked. The health coach providing the intervention and the caregiver participants were not be blinded. All baseline data were collected prior to randomizing. Timing of follow-up assessments were based on day of randomization.

The study intervention was provided to individual caregivers. All caregivers (both groups) were provided with access to an Internet site with excellent health information (HI). The virtual support intervention (ViCCY \["Vicky"\] - Virtual Caregiver Coach for You) was provided through tablet devices provided to caregivers in the intervention group. We provided tablets to all the caregivers, assuring that they had wireless network access so they can access the Internet site providing HI content. Caregivers in the control group received only HI but caregivers in the intervention group received 10 sessions of ViCCY over 6 months.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was based on the Transactional Model of Stress and Coping. Stressful experiences such as caregiving demand - circumstances that give rise to real or perceived stress - are construed as person-environment transactions. Primary appraisal of demand involves assessment of its significance, which results in perceived burden. Secondary appraisal involves assessment of the resources available to cope with it. These appraisals lead to the coping effort. Without successful coping, self-care is poor, which decreases health status in caregivers. The virtual support intervention \[ViCCY ("Vicky") - Virtual Caregiver Coach for You\] addressed both appraisal and coping.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The investigator was blinded to the assignment of participant to the two different arms in the study.

Study Groups

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Intervention

Caregivers randomized to the intervention ViCCY received 10 sessions of virtual health coaching by trained health coaches over 6 months with content based on the theoretical framework (the Transactional Model of Stress and Coping) and prior research. In addition, they received the same health information as that provided to the caregivers in the control arm. Sessions were provided through tablets. We helped caregivers gain the knowledge and skills needed to achieve self-identified health goals through self-care using motivational interviewing. We focused on identifying personal values, solving problems, and transforming goals into action. ViCCY was standardized in a treatment manual. Because stress does not affect all people equally, the intervention was tailored to individual appraisals and the factors most likely to influence demand and perceived burden.

Group Type EXPERIMENTAL

ViCCY

Intervention Type BEHAVIORAL

Virtual Caregiver Coach for You

Control

The control group received Health Information (HI) delivered through the internet.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ViCCY

Virtual Caregiver Coach for You

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Informal caregiver of adults with heart failure providing care at least 8 hours/week, reporting poor self-care on screening (Health Self-Care Neglect scale score \>=2 based on our pilot data), able to complete the protocol, e.g., adequate vision and hearing, and English speaking were required for enrollment.

Exclusion Criteria: Cognitive impairment (Telephone Interview for Cognitive Status \[TICS\] \<25), Participation in another clinical trial of a support intervention, Untreated major psychiatric illness (Use of anti-anxiety/antidepressant medicines was acceptable and will be adjusted in analysis if group imbalance is identified).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No