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Clinical Trials/NCT06071221
NCT06071221
Recruiting
Not Applicable

Improving the Mental Health of Home Health Aides: A Pilot Randomized Controlled Trial

Weill Medical College of Cornell University2 sites in 1 country100 target enrollmentJanuary 27, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health Issue
Sponsor
Weill Medical College of Cornell University
Enrollment
100
Locations
2
Primary Endpoint
Fidelity to study protocol (intervention arm)
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 27, 2025
End Date
June 1, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Fidelity to study protocol (intervention arm)

Time Frame: at 6 months post-intervention

Measured by the number of total meeting attendance

Fidelity to study protocol (control arm)

Time Frame: at 6 months post-intervention

Measured by the number of total meeting attendance

Adherence to the intervention

Time Frame: at 6 months post-intervention

Measured by the proportion of participants who completed three or more sessions

Fidelity to session completion (intervention arm)

Time Frame: at 6 months post-intervention

Measured by number of sessions completed (participants)

Fidelity to session completion (control arm)

Time Frame: at 6 months post-intervention

Measured by number of sessions completed (participants)

Fidelity to study protocol (intervention)

Time Frame: at 6 months post-intervention

Measured by number intervention components delivered (peer coaches)

Accrual rate

Time Frame: 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.

Time Frame: 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

Time Frame: at 3 months

Measured by the number of participants who refuse to participate divided by the number of eligible participants

Acceptability

Time Frame: at 6 months post-intervention

Measured by the proportion of participants responding positively to a quantitative exit survey

Secondary Outcomes

  • 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))

Study Sites (2)

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