Heart Failure Clinical Trial
Improving Self-care of Heart Failure Caregivers
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 have developed and pilot tested a virtual support intervention (ViCCY ("Vicky")-Virtual Caregiver Coach for you), that we propose to evaluate among HF caregivers. Using randomized controlled trial (RCT) design, we will enroll 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 will receive standard care augmented with Health Information (HI) delivered through the Internet, but the ViCCY caregiver group will also receive 10 front-loaded coaching support sessions tailored to individual issues. The control group will have 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 will collect self-reported data on self-care, stress, coping, and health status. At 6 months, we will compare ViCCY to HI alone to assess intervention efficacy using intent-to-treat analysis. Our pilot data suggest that addition of support provided by the health coach will make ViCCY more efficacious than HI alone. A sample of 250 caregivers (125/arm) will provide >90% power to detect significant differences between the groups on the primary outcome of self-care (Aim 1). We will collect 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 will participate, we will consent a subgroup of the HF patients cared for by these caregivers (at least 40 dyads). 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.
We will use 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 will block randomize the caregivers to achieve equal distribution of key variables in each condition. We will block randomize on caregiver sex (male/female) and relationship to patient (e.g., spouse) - factors shown to influence perceived caregiving burden and receptivity to intervention. The randomization sequence will be 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 will notify the study staff and participants of their group assignment (intervention or control) by telephone, email or message, as preferred by the individual. Although balance in sample size can be achieved with block randomization, the groups may not be fully comparable on other factors. Initial comparison of the groups will allow us to control for important covariates in the analyses. Investigators and all staff involved in collecting assessment data will be blinded to group assignment until after the data are locked. The nurse providing the intervention and the caregiver participants will not be blinded. All baseline data will be collected prior to randomizing. Timing of follow-up assessments will be based on day of randomization.
The study intervention will be provided to individual caregivers. All caregivers (both groups) will be provided with access to an Internet site with excellent health information (HI). In addition, we have developed and pilot tested a virtual support intervention (ViCCY ["Vicky"] - Virtual Caregiver Coach for You), that we will provide on tablet devices to caregivers in the intervention group. We will provide tablets to all the caregivers, assuring that they have wireless network access so they can access the Internet site providing HI content. Caregivers in the control group will receive only HI but caregivers in the intervention group will receive 10 front-loaded sessions of ViCCY over 6 months.
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, English speaking, and living within 50 miles of the research office in case home visits are required for enrollment or Internet set-up.
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 is acceptable and will be adjusted in analysis if group inbalance is identified), and plans to move out of the area imminently.
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States
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