Heart Failure Resilience Intervention for Caregivers (HEROIC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Goal Attainment of Preventive Health Behaviors as Measured by the Goal Attainment Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aim 1 inclusion criteria:
- •Patients with a HF hospitalization in the last year and their informal caregivers (inclusion criteria below), nurse practitioners, physicians and members of the multidisciplinary team rounds will be included in focus groups.
- •Aim 2 & 3 Inclusion:
- •Caregivers of patients served by the HF Bridge Clinic will be included if
- •the patient was hospitalized within 6 months
- •the caregiver agrees to work on goals that increase preventive health behaviors and/or decrease burden
- •caregivers live with the patient or visit them to provide care more than 3 times per week
- •the caregiver is 50 years or older and e) the caregiver is the spouse/partner or child of the patient.
排除标准
- •Caregivers who
- •themselves have a terminal diagnosis
- •or are cognitively impaired based on Mini-Mental State Examination (MMSE) screening will be excluded as response to the intervention may vary in these groups.
研究组 & 干预措施
HEROIC Intervention Group
This group will receive the HEROIC intervention.
干预措施: HEROIC (Behavioral)
Waitlist Control Group
The waitlisted group will receive usual care for caregivers for the first 12 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 12 weeks, they will begin the intervention.
干预措施: HEROIC (Behavioral)
结局指标
主要结局
Goal Attainment of Preventive Health Behaviors as Measured by the Goal Attainment Scale
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Self-Efficacy as Assessed by the Coping Self Efficacy Scale(Baseline, 12 and 24 weeks)