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出境医 / 临床实验 / Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : October 1, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021
Arms and Interventions
Arm Intervention/treatment
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 :
  1. 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.


Secondary Outcome Measures :
  1. 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



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Naresh Punjabi, M.D. 410-550-2632 npunjabi@jhmi.edu
Contact: Joseph Carrese, M.D. 4105022092 jhmeirb@jhmi.edu

Locations
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United States, Maryland
Department of Medicine, Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Principal Investigator    833-354-3727      
Sponsors and Collaborators
Johns Hopkins University
Fusion Health
Investigators
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Principal Investigator: Naresh Punjabi, M.D. Johns Hopkins University
Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes
Official Title  ICMJE Comparing Recruitment Strategies for a Randomized Controlled Trial in Sleep Apnea and Prediabetes
Brief Summary Recruitment strategies comparing different strategies.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Sleep Disorder
  • Pre Diabetes
  • Obstructive Sleep Apnea
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Lifestyle Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Naresh Punjabi, M.D. 410-550-2632 npunjabi@jhmi.edu
Contact: Joseph Carrese, M.D. 4105022092 jhmeirb@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984058
Other Study ID Numbers  ICMJE IRB00199862
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Fusion Health
Investigators  ICMJE
Principal Investigator: Naresh Punjabi, M.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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