Improving the Mental Health of Home Health Aides

NCT06071221 | Recruiting

• 1 other identifier: 22-02024420
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Mental Health Issue

Keywords

behavioral health intervention; home health aide; depressive symptoms; peer coaching; stress

Outcome Measures

Primary Outcomes (10)

• Fidelity to study protocol (intervention arm)

  Measured by the number of total meeting attendance

  at 6 months post-intervention

• Fidelity to study protocol (control arm)

  Measured by the number of total meeting attendance

  at 6 months post-intervention

• Fidelity to session completion (intervention arm)

  Measured by number of sessions completed (participants)

  at 6 months post-intervention

• Fidelity to session completion (control arm)

  Measured by number of sessions completed (participants)

  at 6 months post-intervention

• Fidelity to study protocol (intervention)

  Measured by number intervention components delivered (peer coaches)

  at 6 months post-intervention

• Accrual rate

  Measured by the number of participants enrolled divided by the number of months the study is open to enrollment

  at 3 months

• Refusal rate

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

  at 3 months

• Retention rate as measured by the proportion of participants who provide 6 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 month post-intervention

• Adherence to the intervention

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

  at 6 months post-intervention

• Acceptability

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

  at 6 months post-intervention

Secondary Outcomes (2)

• Change in depressive symptoms from baseline compared to 6 month assessed with the PHQ-8

  From baseline to 6-month post-intervention

• 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)

Other Outcomes (2)

• Change in stress from baseline compared to 6 months assessed with the Cohen's Perceived Stress (PSS-4) 4-item scale

  From baseline to 6-month post-intervention

• Change in loneliness from baseline compared to 6 months assessed with the UCLA Loneliness scale 3-item scale

  From baseline to 6-month post-intervention

Study Arms (2)

Living Healthy educational program + Peer Coaching

EXPERIMENTAL

Home Health Aides (HHAs) will receive educational content via the CareConnect application, an eLearning mobile platform that provides educational courses for HHA certification and keeps track of their service hours to maintain NYS compliance. HHAs in this intervention arm will receive the 8-session adapted Living Healthy program via CareConnect over 3 months. Each HHA will be paired with a trained Peer Coach participant who will work through the structured program with the HHA.

Behavioral: Living Healthy educational program + peer coaching

Living Healthy educational program

ACTIVE COMPARATOR

Home Health Aides (HHAs) in the attention control arm will receive an 8-session CareConnect delivered general health program (covering topics distinct from the Living Healthy intervention) that is strictly informational without any elements of CBT.

Behavioral: Living Healthy educational program

Interventions

Living Healthy educational program + peer coaching BEHAVIORAL

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.

Living Healthy educational program + Peer Coaching

Living Healthy educational program BEHAVIORAL

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.

Living Healthy educational program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Doris Duke Charitable Foundation: collaborator
• Weill Medical College of Cornell University: lead

Study Sites (2)

1199 SEIU Home Care Industry Education Fund

New York, New York, 10018, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Madeline R Sterling, MD, MPH, MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline R Sterling, MD, MPH, MS

CONTACT

6469625029; mrs9012@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 6, 2023
• Study Start: January 27, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)