Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06071221

Conditions

Mental Health Issue

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Living Healthy educational program + peer coaching

Living Healthy educational program

Study Details

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

Study ID

NCT06071221

Start date

Jan 27, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Living Healthy educational program + Peer Coaching

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.

active comparator: Living Healthy educational program

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.

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Madeline R Sterling, MD, MPH, MS

6469625029mrs9012@med.cornell.edu

Locations

1199 SEIU Home Care Industry Education Fund

Recruiting

New York, New York, United States, 10018

Contacts

Faith Wiggins

faith.wiggins@1199funds.org

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Madeline R Sterling, MD, MPH, MS

646-962-5029mrs9012@med.cornell.edu

Principal Investigator:

Madeline R Sterling, MD, MPH, MS

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-20.