Improving Self-Care of Informal Caregivers of Adults With Heart Failure
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- University of Pennsylvania
- Enrollment
- 343
- Locations
- 1
- Primary Endpoint
- Change in the Health Self-Care Neglect (HSCN) Scale
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Barbara Riegel, PHD, RN
Investigator
University of Pennsylvania
Eligibility 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).
Outcomes
Primary Outcomes
Change in the Health Self-Care Neglect (HSCN) Scale
Time Frame: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
The Health Self-Care Neglect (HSCN) scale measures an individual's neglect of self-care behaviors. It consists of 9 yes or no questions. Scores range from 0-9. Higher scores indicating more self-care neglect.
Change in the Self-Care Inventory, Maintenance Scale
Time Frame: The primary outcome was analyzed at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.
The Self-Care Inventory is a 20 item inventory with 3 embedded scales (self-care maintenance, monitoring, and management). The outcome used in this study was the 8-item Self-Care Maintenance Scale. Responses are added and standardized to range from 0-100. A higher score indicates better self-care.
Secondary Outcomes
- Change in the Perceived Stress Scale (PSS)(Main analysis was Baseline to 6 months. Data will be analyzed at 12 months to determine sustainability of intervention effect.)
- Change in the Ways of Coping Questionnaire(The primary analysis was at 6 months (baseline compared to 6 months) but data were collected at 9- and 12-months to assess sustainability.)
- Change in Health Status as Measured by the Short Form-36 (Physical and Mental Health Status)(Main analysis Baseline to 6 months. Sustainability assessed at 12 months.)
- Change in the Caregivers' SF-6D (Short Form Six-dimension) Scores(Measured at baseline, 3, 6, 9, and 12 months; primary analysis baseline to 12 months)
- Difference in Caregivers' Hospital and Provider Events(Data were collected at Baseline, 3, 6, 9, and 12 months. The primary analysis was done using the baseline to 12 month period.)