Clinical trial NCT06071221: Improving the Mental Health of Home Health Aides
Official title: Improving the Mental Health of Home Health Aides: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: behavioral health intervention
home health aide
depressive symptoms
peer coaching
stress
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2023-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Speak a language other than English or Spanish
* Less than 1 year of job experience as a home health aide

Primary outcomes:
measure: Fidelity to study protocol (intervention arm)
timeFrame: at 6 months post-intervention
measure: Fidelity to study protocol (control arm)
timeFrame: at 6 months post-intervention
measure: Fidelity to session completion (intervention arm)
timeFrame: at 6 months post-intervention
measure: Fidelity to session completion (control arm)
timeFrame: at 6 months post-intervention
measure: Fidelity to study protocol (intervention)
timeFrame: at 6 months post-intervention
measure: Accrual rate
timeFrame: at 3 months
measure: Refusal rate
timeFrame: at 3 months
measure: Retention rate as measured by the proportion of participants who provide 6 month combined data.
timeFrame: at 6 month post-intervention
measure: Adherence to the intervention
timeFrame: at 6 months post-intervention
measure: Acceptability
timeFrame: at 6 months post-intervention
Secondary outcomes:
measure: Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8
timeFrame: From baseline to 6-month post-intervention
measure: Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8
timeFrame: From baseline to 6-month post-intervention (attention control arm)
Other outcomes:
measure: Change in stress from baseline compared to 6 months assessed with the Cohen's Perceived Stress (PSS-4) 4-item scale
timeFrame: From baseline to 6-month post-intervention
measure: Change in loneliness from baseline compared to 6 months assessed with the UCLA Loneliness scale 3-item scale
timeFrame: From baseline to 6-month post-intervention
Locations:
city: New York
country: United States
facility: 1199 SEIU Home Care Industry Education Fund
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Madeline R Sterling, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: