MINDSET: Improving the Mental Health of Home Health Aides

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06071221
Collaborator
Doris Duke Charitable Foundation (Other)
100
2
2
15
50
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Living Healthy educational program + peer coaching
  • Behavioral: Living Healthy educational program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Improving the Mental Health of Home Health Aides: A Pilot Randomized Controlled Trial
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Living Healthy educational program + Peer Coaching

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 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.

Active Comparator: Living Healthy educational program

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.

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Refusal rate as measured by the number of participants who refuse to participate divided by the number of eligible participants. [at 3 months]

  3. Fidelity to the study protocol as measured by the number of total meeting attendance. [at 6 months post-intervention]

  4. Fidelity to the study protocol as measured by the number of total meeting attendance. [at 12 months post-intervention]

  5. Fidelity to the study protocol as measured by number of sessions completed (participants) [at 6 months post-intervention]

  6. Fidelity to the study protocol as measured by number of sessions completed (participants) [at 12 months post-intervention]

  7. Fidelity to the study protocol as measured by number intervention components delivered (peer coaches). [at 6 months post-intervention]

  8. Fidelity to the study protocol as measured by number intervention components delivered (peer coaches). [at 12 months post-intervention]

  9. Retention rate as measured by the proportion of participants who provide 6 and 12-month combined data. [at 6 and 12-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.

  10. Adherence to the intervention as measured by the proportion of participants who completed three or more sessions. [at 6 months post-intervention]

  11. Acceptability as measured by the proportion of participants responding positively to a quantitative exit survey [at 6 months post-intervention]

    The Likert scale to be used for this measure is under development.

Secondary Outcome Measures

  1. Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8 [From baseline to 6-month post-intervention]

    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.

  2. Change in depressive symptoms from baseline compared to 12 month assessed with the PHQ-8 [From baseline to 12-month post-intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 1199 SEIU Home Care Industry Education Fund New York New York United States 10018
2 Weill Cornell Medicine New York New York United States 10021

Sponsors and Collaborators

  • Weill Medical College of Cornell University
  • Doris Duke Charitable Foundation

Investigators

  • Principal Investigator: Madeline R Sterling, MD, MPH, MS, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT06071221
Other Study ID Numbers:
  • 22-02024420
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weill Medical College of Cornell University

Study Results

No Results Posted as of Oct 6, 2023