Heart Failure Resilience Intervention for Caregivers (HEROIC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Goal Attainment of Preventive Health Behaviors as Measured by the Goal Attainment Scale
Study Overview
Brief Summary
Heart failure (HF) patients with supportive caregivers have better physical health, emotional health, and quality of life. But caregivers have an increased risk of caregivers' own worsening health and often feel a sense of burden related to caregiving. However, caregivers receive very little support to balance caring for the patient with caring for themselves. Therefore, this research will provide a program for caregivers of advanced heart failure patients to build on the caregiver's strengths, sense of purpose, and set goals for healthy lifestyle changes. The investigators believe that caregivers who receive the program will have better quality of life, less sense of burden, and a healthier lifestyle.
Detailed Description
Aim 1) Develop the intervention through focus groups and human-centered design with key stakeholders with particular focus on race, gender and financial strain. Key stakeholders including patients, caregivers and healthcare providers will discuss prototypes and refine intervention components through human-centered design.
Aim 2) Refine intervention components through an open label pilot (N=5) of the intervention, followed by in-depth interviews. We will assess the salient features of the novel intervention components using mixed methods including examination of all quantitative measures and qualitative interviews to explore acceptability, participant/interventionist interactions, home environment factors, goal achievement and perceived value of intervention. Intervention components will be adapted for the trial based on results of aims 1 and 2.
Aim 3) Conduct a single-masked, waitlist control pilot trial of the HEROIC intervention (N=36). We hypothesize that caregivers who receive the intervention will show greater improvement in primary outcomes (preventive health behaviors, caregiver burden and QOL) and potential mechanisms (self-efficacy and biomarkers of resilience [interleukins 6 and 10]) than control caregivers.
Randomization: Caregivers will be randomized using a computer algorithm via REDCap to receive either: (1) intervention or (2) waitlist. Random assignment will be stratified by spousal vs non-spousal caregivers due to increased burden among non-spousal caregivers.
Waitlisted Control Group: The waitlisted group will receive usual care for caregivers for the first 16 weeks, which is normally limited to inclusion in some clinical assessment and teaching during patient visits. Waitlisted participants will receive monthly study postcards to encourage retention. After 16 weeks, they will begin the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Goal Attainment of Preventive Health Behaviors as Measured by the Goal Attainment Scale
Time Frame: Baseline, 12 and 24 weeks
The Goal Attainment Scale is a self-reported attainment of goals implementing health-promoting behaviors, reported on a 5-point scale. Scores are converted to t-scores (0-100). 50 indicates the population mean with a standard deviation of 10. Higher scores indicate higher goal attainment.
Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale
Time Frame: Baseline, 12 and 24 weeks
Investigators will use the task difficulty and time caregiving subscales of the Oberst Caregiving Burden Scale. Both sub-scales include 15 likert scale items each. Scores range from 15-75 for the task difficulty and 15-75 for the time caregiving sub-scales. Higher scores indicate great task difficulty; higher scores indicate more time spent caregiving. Sub-scales are not combined in a total score.
Quality of Life as Assessed by the Neurological Quality of Life(Neuro-QOL)
Time Frame: Baseline, 12 and 24 weeks
9-Item Neurological Quality of Life (Neuro-QOL). Items are scored on a 1-5 range, with total summary score calculated range of 9-45. Higher scores indicate a more favorable quality of life.
Secondary Outcomes
- Self-Efficacy as Assessed by the Coping Self Efficacy Scale(Baseline, 12 and 24 weeks)