Improving the Mental Health of Home Health Aides: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Fidelity to study protocol (intervention arm)
研究概览
简要总结
The goal of this study is to improve the mental health of home health aides, a workforce that provides care for adults at home but whose own health has been historically poor. The main questions the study aims to answer are:
- Will a health program called Living Healthy, which provides health education and support with positive thinking, be used by home health aides and do they like it?
- Does Living Healthy actually improve home health aides' mood compared to what they usually do to take care of themselves?
Participants in the study will get an 8-week health program called Living Healthy over 3 months. Some of the participants will also have a 'peer coach' who is another home health aide who's been trained to help them with the program and learn some ways to feel better.
The study will compare the experiences of home health aides who get Living Healthy plus a peer coach with those who only get the Living Healthy program.
详细描述
The overall goal of the proposed project is to improve the mental health of home health aides, one of the fastest growing sectors of the healthcare industry, comprised predominantly of middle-aged women of color with high levels of stress, depressive symptoms, and emotional exhaustion. Improving home health aides' mental health and well-being is not only critical to their own longevity as a workforce, but it has the potential to improve the health of the patients for whom they care. The investigators propose adapting the Living Healthy intervention, a 8-session peer coach-delivered cognitive behavioral therapy program on healthy habits, to the home health aide workforce and pilot testing it. The specific aim of this study is to conduct a 2-arm pilot randomized control trial among 100 home health aides (intervention arm: 50; enhanced usual care arm: 50) to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention compared to enhanced usual care (education on healthy habits alone). The primary hypothesis is that the intervention will be feasible (>80% of aides will complete the program) and acceptable (>90% of aides will report high levels of satisfaction). The secondary hypothesis is that participants who receive the intervention arm will experience fewer depressive symptoms at follow-up, compared to those in the control arm. Most of the study will be conducted virtually, while initial onboarding may be in-person.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently working as a home health aide
- •Speak English or Spanish
- •≥ 18 years of age
- •Have mild depressive symptoms (Personal Health Questionnaire 8-item [PHQ8] scale ≥ 5 points), or other risk factors for poor mental health as assessed by the following domains including stress (Cohen's Perceived Stress 4-item scale [PSS4] ≥5) or loneliness (≥6 on the 3-item UCLA Loneliness scale).
排除标准
- •Speak a language other than English or Spanish
- •Less than 1 year of job experience as a home health aide
研究组 & 干预措施
Living Healthy educational program + Peer Coaching
Home Health Aides (HHAs) will receive educational content via the CareConnect application, an eLearning mobile platform that provides educational courses for HHA certification and keeps track of their service hours to maintain NYS compliance. HHAs in this intervention arm will receive the 8-session adapted Living Healthy program via CareConnect over 3 months. Each HHA will be paired with a trained Peer Coach participant who will work through the structured program with the HHA.
干预措施: Living Healthy educational program + peer coaching (Behavioral)
Living Healthy educational program
Home Health Aides (HHAs) in the attention control arm will receive an 8-session CareConnect delivered general health program (covering topics distinct from the Living Healthy intervention) that is strictly informational without any elements of CBT.
干预措施: Living Healthy educational program (Behavioral)
结局指标
主要结局
Fidelity to study protocol (intervention arm)
时间窗: at 6 months post-intervention
Measured by the number of total meeting attendance
Fidelity to study protocol (control arm)
时间窗: at 6 months post-intervention
Measured by the number of total meeting attendance
Adherence to the intervention
时间窗: at 6 months post-intervention
Measured by the proportion of participants who completed three or more sessions
Fidelity to session completion (intervention arm)
时间窗: at 6 months post-intervention
Measured by number of sessions completed (participants)
Fidelity to session completion (control arm)
时间窗: at 6 months post-intervention
Measured by number of sessions completed (participants)
Fidelity to study protocol (intervention)
时间窗: at 6 months post-intervention
Measured by number intervention components delivered (peer coaches)
Accrual rate
时间窗: at 3 months
Measured by the number of participants enrolled divided by the number of months the study is open to enrollment
Retention rate as measured by the proportion of participants who provide 6 month combined data.
时间窗: at 6 month post-intervention
Participants who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention.
Refusal rate
时间窗: at 3 months
Measured by the number of participants who refuse to participate divided by the number of eligible participants
Acceptability
时间窗: at 6 months post-intervention
Measured by the proportion of participants responding positively to a quantitative exit survey
次要结局
- Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8(From baseline to 6-month post-intervention (attention control arm))