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

June 26, 2019 updated by: NYU Langone Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep Hygiene Index
Time Frame: 6 months
6 months
Apnea Knowledge/Apnea Belief Scale
Time Frame: 6 months
6 months
Self-Efficacy Scale
Time Frame: 6 months
6 months
Change Assessment Scale
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

July 22, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-01011
  • 1R25HL116378-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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