Improving the Mental Health of Home Health Aides

Official title

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

Overview

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.

Interventions

• Behavioral Living Healthy educational program + peer coaching
  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
• Behavioral Living Healthy educational program
  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.

Primary outcome measures

• Fidelity to study protocol (intervention arm) [Time frame: at 6 months post-intervention]
• Fidelity to study protocol (control arm) [Time frame: at 6 months post-intervention]
• Fidelity to session completion (intervention arm) [Time frame: at 6 months post-intervention]
• Fidelity to session completion (control arm) [Time frame: at 6 months post-intervention]
• Fidelity to study protocol (intervention) [Time frame: at 6 months post-intervention]
• Accrual rate [Time frame: at 3 months]
• Refusal rate [Time frame: at 3 months]
• Retention rate as measured by the proportion of participants who provide 6 month combined data. [Time frame: at 6 month post-intervention]
• Adherence to the intervention [Time frame: at 6 months post-intervention]
• Acceptability [Time frame: at 6 months post-intervention]

Secondary outcome measures (2)

• Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8 [Time frame: From baseline to 6-month post-intervention]
• Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8 [Time frame: From baseline to 6-month post-intervention (attention control arm)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 2 centers

• 1199 SEIU Home Care Industry Education Fund — New York
• Weill Cornell Medicine — New York

Identifiers

NCT: NCT06071221 · 22-02024420

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗