Improving the Mental Health of Home Health Aides

Study Overview
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Brief Summary
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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.

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

Conditions
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Mental Health Issue

Intervention / Treatment
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* Behavioral: Living Healthy educational program + peer coaching
* Behavioral: Living Healthy educational program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently working as a home health aide Speak English ≥ 18 years of age Have ≥ 1 risk factor for poor mental health as assessed by the following domains and their corresponding validated scales: depressive symptoms (Personal Health Questionnaire 8-item [PHQ8] scale ≥ 5 points), stress (Cohen's Perceived Stress 4-item scale [PSS4] ≥5), loneliness (≥6 on the 3-item UCLA Loneliness scale), and overall mental health (Mental Component Summary [MCS] scores from the Short Form-12 item scale <50). Exclusion Criteria: Speak a language other than English Less than 1 year of job experience as a home health aide

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Living Healthy educational program + Peer Coaching<br> | Behavioral: Living Healthy educational program + peer coaching<br>* The Living Healthy intervention is an 8-session health education program with cognitive behavioral training (CBT) techniques. For those in the interventional arm, the Living Healthy intervention program will be delivered by trained peer coaches by telephone or Zoom over 3 months. In this study, trained peer coaches are trained home health aides themselves. Informed by social cognitive theory (SCT), peer coaches train participants on cognitive behavior techniques and empower participants to adopt positive health behaviors through personalized goal setting, motivational interviewing, and peer modeling. Each content-based session incorporates principles of CBT, teaching participants to recognize and modify negative thinking and modifying outcome expectations through self-monitoring, reflection, and practice.<br>|
| Active Comparator: Living Healthy educational program<br> | Behavioral: Living Healthy educational program<br>* Participants assigned to receive health education alone will be asked to read health education (online; covering aspects of the Living Healthy program) which corresponds to a weekly topic about health. They will be called by a research assistant each week to prompt them to do this and answer any questions they might have about the materials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual rate as measured by the number of participants enrolled divided by the number of months the study is open to enrollment |  | at 3 months | 
| Refusal rate as measured by the number of participants who refuse to participate divided by the number of eligible participants. |  | at 3 months | 
| Fidelity to the study protocol as measured by the number of total meeting attendance. |  | at 6 months post-intervention | 
| Fidelity to the study protocol as measured by the number of total meeting attendance. |  | at 12 months post-intervention | 
| Fidelity to the study protocol as measured by number of sessions completed (participants) |  | at 6 months post-intervention | 
| Fidelity to the study protocol as measured by number of sessions completed (participants) |  | at 12 months post-intervention | 
| Fidelity to the study protocol as measured by number intervention components delivered (peer coaches). |  | at 6 months post-intervention | 
| Fidelity to the study protocol as measured by number intervention components delivered (peer coaches). |  | at 12 months post-intervention | 
| Retention rate as measured by the proportion of participants who provide 6 and 12-month combined data. | Participants who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. | at 6 and 12-month post-intervention | 
| Adherence to the intervention as measured by the proportion of participants who completed three or more sessions. |  | at 6 months post-intervention | 
| Acceptability as measured by the proportion of participants responding positively to a quantitative exit survey | The Likert scale to be used for this measure is under development. | at 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8 | We will assess the change in depressive symptoms using the PHQ-8, a validated scale that assesses depressive symptoms. This scale is composed of 8 Likert-type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day). Total score ranges from 0 to 24. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Change will be measured with repeated Anova analysis. | From baseline to 6-month post-intervention | 
| Change in depressive symptoms from baseline compared to 12 month assessed with the PHQ-8 | We will assess the change in depressive symptoms using the PHQ-8, a validated scale that assesses depressive symptoms. This scale is composed of 8 Likert-type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day). Total score ranges from 0 to 24. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Change will be measured with repeated Anova analysis. | From baseline to 12-month post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral health intervention, home health aide, depressive symptoms, peer coaching, stress