Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks

NCT03354520 | Withdrawn

• 1 other identifier: 17-01097
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to maximize efficacy of message delivery to achieve desired Obstructive sleep apnea (OSA) adherence goal. Newly diagnosed black patients (n=390, all genders) from participating sleep clinics will be randomly exposed to either the individually tailored or standard OSA messages. Investigators will look at an effective and scalable intervention to improve OSA-related outcomes: a) clinical CVD and brain health measures and b) patient-centered outcomes. Patient-centered and adherence data will be captured via REDCap, enabling real-time application of data-driven decision rules while implementing the intervention.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change from Baseline OSA Self-Efficacy Scale Score to 6 Months Score

  The mean of the nonmissing item responses was calculated for each of the 3 subscales: Perceived Risk, Outcome Expectancies, and Treatment Self-Efficacy. Using this mean-weighted score prevents the distortion of the score from missing responses. Factor 1 (Risk Perception consisting of 8 questions); Factor 2 (Outcome Expectancy consisting of 9 items) and Factor 3 (Treatment Self Efficacy consisting of 9 items) are given a potential score of 1-4.

  2 Months and 6 Months

Study Arms (3)

Tailored Videos

ACTIVE COMPARATOR

Behavioral: Tailored Videos

Standard Videos

ACTIVE COMPARATOR

Behavioral: Standard Videos

OSA Treatment

ACTIVE COMPARATOR

Behavioral: OSA Treatment

Interventions

Tailored Videos BEHAVIORAL

web-based OSA messages (videos featuring role models and coaching advice using motivational enhancement) addressing OSA barriers within a health literacy framework--to decrease cognitive load and render messages understandable and actionable. OSA messages were tailored based on focus group data in the previous study (group tailoring).

Tailored Videos

OSA Treatment BEHAVIORAL

Web-based platform delivering messages promoting OSA self-efficacy. . All patients will view the introductory video, followed by the video cluster: Sleep, Health, and Well-Being; Sleep-Heart Health; Lifestyle Changes; and Sleep Hygiene.

OSA Treatment

Standard Videos BEHAVIORAL

Patients in the control arm will also receive an iPad, providing access to standard online OSA health information (e.g., National Sleep Foundation) in an equivalent dose as in the intervention arm using pre-selected automatic alerts to access the website

Standard Videos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported race/ethnicity as African American, African, Caribbean or black
• Accessible by phone
• No plans to move away within the year
• OSA diagnosis, consent, including permission to release medical data
• Physician-diagnosed medical conditions.

You may not qualify if:

• Progressive illnesses in which disability or death is expected within 1 year
• Impaired cognitive/ functional ability precluding participation
• Intention to move within the same year of enrollment
• Family member currently enrolled

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 28, 2017
• Study Start: June 18, 2021
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Requests should be directed to Ferdinand.Zizi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)