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

Primary Purpose

Healthcare Disparities, Minority Health, Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored sleep health education materials.
Generic sleep health education materials.
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthcare Disparities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Sleep Hygiene Index
Apnea Knowledge/Apnea Belief Scale
Self-Efficacy Scale
Change Assessment Scale

Secondary Outcome Measures

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

Full Information

First Posted
July 21, 2015
Last Updated
June 26, 2019
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02507089
Brief Title
Tailored Approach to Sleep Health Education: A Community Engaged Approach
Acronym
TASHE
Official Title
Tailored Approach to Sleep Health Education: A Community Engaged Approach
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthcare Disparities, Minority Health, Sleep, Sleep Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tailored sleep health education materials.
Intervention Description
Tailored sleep health materials.
Intervention Type
Behavioral
Intervention Name(s)
Generic sleep health education materials.
Primary Outcome Measure Information:
Title
Sleep Hygiene Index
Time Frame
6 months
Title
Apnea Knowledge/Apnea Belief Scale
Time Frame
6 months
Title
Self-Efficacy Scale
Time Frame
6 months
Title
Change Assessment Scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
7-Day Physical Activity Recall
Time Frame
6 months
Title
By-Meal Fruit/Vegetable Intake Screener
Time Frame
6 months
Title
Rapid Estimate of Adult Literacy in Medicine
Time Frame
6 months
Title
Medical Outcomes Study Short Form 36
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Girardin Jean-Louis, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32329437
Citation
Jean-Louis G, Robbins R, Williams NJ, Allegrante JP, Rapoport DM, Cohall A, Ogedegbe G. Tailored Approach to Sleep Health Education (TASHE): a randomized controlled trial of a web-based application. J Clin Sleep Med. 2020 Aug 15;16(8):1331-1341. doi: 10.5664/jcsm.8510.
Results Reference
derived
PubMed Identifier
27931249
Citation
Williams NJ, Robbins R, Rapoport D, Allegrante JP, Cohall A, Ogedgebe G, Jean-Louis G. Tailored approach to sleep health education (TASHE): study protocol for a web-based randomized controlled trial. Trials. 2016 Dec 8;17(1):585. doi: 10.1186/s13063-016-1701-x.
Results Reference
derived

Learn more about this trial

Tailored Approach to Sleep Health Education: A Community Engaged Approach

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