Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT03984058

Collaborator

Fusion Health (Other)

Enrollment

Location

Arm

19.5

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Recruitment strategies comparing different strategies.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder Pre Diabetes Obstructive Sleep Apnea	Behavioral: Lifestyle Intervention	N/A

Detailed Description

Patients with prediabetes and moderate-to-severe Obstructive Sleep Apnea (OSA). To determine the recruitment yields from electronic medical record (EMR) vs the general community. To assess the adherence to positive airway pressure (PAP) therapy among patients with prediabetes and moderate-to-severe OSA.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Comparing Recruitment Strategies for a Randomized Controlled Trial in Sleep Apnea and Prediabetes

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

May 17, 2021

Actual Study Completion Date :

May 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR) [1 year]
Determine recruitment yield from EMR versus the general community.

Secondary Outcome Measures

Adherence to Pap Therapy as assessed by the ResMed AirView Remote Monitoring system [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Prediabetes: A1c value of 6.0-6.4% and fasting glucose of 100-125 mg/dl
Moderate-to-severe OSA [4% oxygen desaturation index (ODI) ≥ 20/h]
Ability to provide informed consent
Able to comply with all study procedures and be available for the study duration
Availability of smart phone

Exclusion Criteria:

BMI < 28 or ≥ 38 kg/m2
Type 1 or Type 2 diabetes mellitus
Pregnancy
Use of glucose-lowering or weight loss medications (e.g., metformin, orlistat, phentermine)
Prior or anticipated bariatric surgery
Current use of PAP or oral appliance therapy for OSA
Commercial driver
Report of a motor vehicle accident or near-miss due to sleepiness within 2 years
Epworth Sleepiness Scale score10 > 18
Current (prevalent) use of oral corticosteroids (within 1 month)
Participation in a concurrent clinical trial
Unstable medical conditions: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension [BP ≥ 160/100 among those with hypertension, requiring 3 or more meds], severe chronic obstructive pulmonary disease, cancer, or active psychiatric disease
Other sleep disorders (e.g., circadian rhythm disorder, working night or rotation shift, short sleep duration based on self-reported habitual sleep patterns < 5 hrs/night)
Use of supplemental oxygen during wakefulness or sleep
Central sleep apnea (central apnea index ≥ 5/h) or Cheyne-Stokes respiration (> 10 minutes of continues period breathing) on the screening home sleep test Resting awake SpO2 < 90%
Chronic opiate use.
Use of illicit drug / marijuana use more than once per week
Difficulty understanding or speaking English
Anything that, in the opinion of the site investigator, would place the participant at increased risk or preclude a participant's ability to adhere to study protocols or complete the study