NCT02507089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

3.4 years

First QC Date

July 21, 2015

Last Update Submit

June 26, 2019

Conditions

Healthcare DisparitiesMinority HealthSleepSleep Disorders

Outcome Measures

Primary Outcomes (4)

  • Sleep Hygiene Index

    6 months

  • Apnea Knowledge/Apnea Belief Scale

    6 months

  • Self-Efficacy Scale

    6 months

  • Change Assessment Scale

    6 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Control

ACTIVE COMPARATOR

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.

Interventions

Tailored sleep health education materials.BEHAVIORAL

Tailored sleep health materials.

Intervention
Generic sleep health education materials.BEHAVIORAL
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (2)

  • 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.

    PMID: 32329437DERIVED

  • 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.

    PMID: 27931249DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Girardin Jean-Louis, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 23, 2015

Study Start

July 1, 2014

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

US(1)