Improving the Mental Health of Home Health Aides

Mental Health Issue Clinical Trial

— MINDSET  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06071221
• Other study ID #: 22-02024420
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Madeline R Sterling, MD, MPH, MS
• Phone: 6469625029
• Email: mrs9012[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	1199 SEIU Home Care Industry Education Fund	New York	New York
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Refusal rate as measured by the number of participants who refuse to participate divided by the number of eligible participants.		at 3 months
Primary	Fidelity to the study protocol as measured by the number of total meeting attendance.		at 6 months post-intervention
Primary	Fidelity to the study protocol as measured by the number of total meeting attendance.		at 12 months post-intervention
Primary	Fidelity to the study protocol as measured by number of sessions completed (participants)		at 6 months post-intervention
Primary	Fidelity to the study protocol as measured by number of sessions completed (participants)		at 12 months post-intervention
Primary	Fidelity to the study protocol as measured by number intervention components delivered (peer coaches).		at 6 months post-intervention
Primary	Fidelity to the study protocol as measured by number intervention components delivered (peer coaches).		at 12 months post-intervention
Primary	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
Primary	Adherence to the intervention as measured by the proportion of participants who completed three or more sessions.		at 6 months post-intervention
Primary	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	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
Secondary	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