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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03354520
Enrollment
0
Registered
2017-11-28
Start date
2021-06-18
Completion date
2021-06-18
Last updated
2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

BEHAVIORALTailored Videos

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).

BEHAVIORALOSA Treatment

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.

BEHAVIORALStandard Videos

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

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline OSA Self-Efficacy Scale Score to 6 Months Score2 Months and 6 MonthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026