Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes
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|ClinicalTrials.gov Identifier: NCT03984058|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorder Pre Diabetes Obstructive Sleep Apnea||Behavioral: Lifestyle Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Recruitment Strategies for a Randomized Controlled Trial in Sleep Apnea and Prediabetes|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Study Arm 1
All enrolled participants will have participants' PAP usage monitored by Fusion Health using the ResMed AirView Remote Monitoring system. Fusion Health will provide individual care for each participant by monitoring daily PAP usage by all study participants. This assessment ensures routine follow-up of PAP adherence during the study. The responsibility for patient care during the study, however, will fall on clinical site staff with any needed assistance by the Fusion Health staff. An intervention will be required when PAP adherence decreases or if any other issues are identified that require a face-to-face visit.
Behavioral: Lifestyle Intervention
A lifestyle intervention program adapted from the Diabetes Prevention Program (DPP). Study participants will start lifestyle intervention on the day of initiating PAP therapy. The 3-month program will be followed: Patient-facing Online Platform: The program will be accessible to study participant via the Web or a Web application available for the Android and iOS devices. Behavioral Weight Loss Goals and Lessons: The program begins with an introductory session that presents the basic goals for the program followed by 12 weekly multimedia lessons. Submission of self-monitoring data: Participants will submit daily weight, caloric intake, and physical activity minutes at least weekly to the study website for 12 weeks. Automated Feedback: In response to the self-monitoring data, participants receive a weekly automated message that compares participants' self-reported values to participants' goals for weekly and overall weight loss, caloric intake, and physical activity minutes.
- Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR) [ Time Frame: 1 year ]Determine recruitment yield from EMR versus the general community.
- Adherence to Pap Therapy as assessed by the ResMed AirView Remote Monitoring system [ Time Frame: 1 Week ]
Participants will have PAP usage monitored with the ResMed AirView Remote Monitoring system. An intervention will be required when PAP adherence decreases or if any other issues are identified that require a face-to-face visit. A phone contact or in-person visit will be scheduled if the following findings observed for ≥3 consecutive nights:
- Suboptimal adherence (< 5 hours per night);
- Mean leak is high (> 20 L/min); or treatment is not optimal (AHI ≥ 5 events/h)
Each participant will have a follow-up visit ~ 7 days after starting PAP therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984058
|Contact: Naresh Punjabi, M.D.||email@example.com|
|Contact: Joseph Carrese, M.D.||firstname.lastname@example.org|
|Principal Investigator:||Naresh Punjabi, M.D.||Johns Hopkins University|