Healthcare DisparitiesTASHENCT02507089

Tailored Approach to Sleep Health Education: A Community Engaged Approach

A study testing Tailored sleep health education materials. and Generic sleep health education materials. in people with Healthcare Disparities and Minority Health, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthcare Disparities, Minority Health, Sleep
What is being tested?: Tailored sleep health education materials. and Generic sleep health education materials.
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 202 participants
Where: 1 siteUnited States
Study dates: Jul 2014to 1 Feb 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Medical Center
New York, New York, 10016

Other trials in United States

About this study

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.

Conditions: Healthcare Disparities, Minority Health, Sleep, Sleep Disorders
Being tested: Tailored sleep health education materials., Generic sleep health education materials.
Medical subject headings: Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tailored sleep health education materials.Behavioural
Tailored sleep health materials.
Generic sleep health education materials.Behavioural

Study groups in NCT02507089
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Generic sleep health education materials.

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleep Hygiene Index
Measured: 6 months
Apnea Knowledge/Apnea Belief Scale
Measured: 6 months
Self-Efficacy Scale
Measured: 6 months
Change Assessment Scale
Measured: 6 months

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20141 Feb 2018

First posted23 Jul 2015 (estimated)
Study startJul 2014
Primary completionDec 2017
Study completion1 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Healthcare DisparitiesStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02507089
Sponsor's protocol ID: 13-01011
Other IDs: 1R25HL116378-01
Acronym: TASHE
Status last verified: Jun 2019
First submitted: 21 Jul 2015
Last updated: 27 Jun 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 32329437
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.
PubMed 27931249

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthcare Disparities trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tailored Approach to Sleep Health Education: A Community Engaged Approach
ClinicalTrials.gov ID: NCT02507089
Acronym / sponsor ID: TASHE / 13-01011
Conditions: Healthcare Disparities, Minority Health, Sleep, Sleep Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Jul 2014
Primary completion: Dec 2017 (actual)
Study completion: 1 Feb 2018 (actual)
First posted: 23 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: Tailored sleep health education materials.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.
Control	Active comparator	Behavioral: Generic sleep health education materials.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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tailored sleep health education materials.Tailored sleep health materials.	Behavioural	Intervention
Generic sleep health education materials.	Behavioural	Control

Primary outcome

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

4 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
Derived from this study: PubMed 32329437Jean-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.
Derived from this study: PubMed 27931249Williams 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.

Related trials for Healthcare Disparities

Not yet recruiting
Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic/Latinx Cancer Patients
Cancer
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Active, not recruiting
UCSD RELINK: Connecting Adults To Supportive Services
Health Care Utilization
RecruitingObservational study
Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Girardin Jean-Louis, PhD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Hygiene Index (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02507089, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.