TASHE: Tailored Approach to Sleep Health Education: A Community Engaged Approach

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT02507089

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

202

Enrollment

Location

Arms

43.1

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to develop educational tools and platforms to promote the transfer of sleep health information to blacks to foster adoption of healthful sleep practices.

Condition or Disease	Intervention/Treatment	Phase
Healthcare Disparities Minority Health Sleep Sleep Disorders	Behavioral: Tailored sleep health education materials. Behavioral: Generic sleep health education materials.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

202 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Tailored Approach to Sleep Health Education: A Community Engaged Approach

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention In this arm, the participants will receive access to a password protected website that features tailored information and educational materials on sleep health and the signs of sleep disorders such as obstructive sleep apnea (OSA). There will be both text-based information on sleep health and OSA, and also videos depicting narrative stories about patients who have been diagnosed with OSA and sought treatment.	Behavioral: Tailored sleep health education materials. Tailored sleep health materials.
Active Comparator: Control In this arm, participants will receive access to generic sleep educational materials that do not feature linguistic or cultural tailoring to the target population. This arm will include access to the same general information (materials on sleep health, sleep disorder signs and symptoms) but be intended for a general audience.	Behavioral: Generic sleep health education materials.

Arm

Intervention/Treatment

Experimental: Intervention

In this arm, the participants will receive access to a password protected website that features tailored information and educational materials on sleep health and the signs of sleep disorders such as obstructive sleep apnea (OSA). There will be both text-based information on sleep health and OSA, and also videos depicting narrative stories about patients who have been diagnosed with OSA and sought treatment.

Behavioral: Tailored sleep health education materials.

Tailored sleep health materials.

Active Comparator: Control

In this arm, participants will receive access to generic sleep educational materials that do not feature linguistic or cultural tailoring to the target population. This arm will include access to the same general information (materials on sleep health, sleep disorder signs and symptoms) but be intended for a general audience.

Behavioral: Generic sleep health education materials.

Outcome Measures

Primary Outcome Measures

Sleep Hygiene Index [6 months]
Apnea Knowledge/Apnea Belief Scale [6 months]
Self-Efficacy Scale [6 months]
Change Assessment Scale [6 months]

Secondary Outcome Measures

7-Day Physical Activity Recall [6 months]
By-Meal Fruit/Vegetable Intake Screener [6 months]
Rapid Estimate of Adult Literacy in Medicine [6 months]
Medical Outcomes Study Short Form 36 [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

self-reported race/ethnicity as African American, African, Caribbean American or black men and women; ages ≥18 years;
accessible by telephone; no plans to move away from the region within the year following enrollment;
consent to participate, which includes permission to release medical record information;
documented OSA risk based on scores received from the Apnea Risk Evaluation System questionnaire

Exclusion Criteria:

progressive medical illness in which disability or death is expected within one year;
impaired cognitive or functional ability which would preclude meaningful participation in the study;
sleep apnea diagnosis;
stated intention to move within the same year of enrollment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Medical Center	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Girardin Jean-Louis, PhD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT02507089

Other Study ID Numbers:

13-01011
1R25HL116378-01

First Posted:

Jul 23, 2015

Last Update Posted:

Jun 27, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Wake Disorders

Study Results

No Results Posted as of Jun 27, 2019