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Sleep Apnea Video Education for CPAP (SAVE-CPAP) (SAVE-CPAP)

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced education
Usual education
Usual follow up
Enhanced follow up
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea focused on measuring OSA, Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged > 18 years of age who are referred to the University of Chicago sleep laboratory for split-night polysomnography by a non-sleep physician and who have a consultation appointment with a sleep physician following the appointment
  • Have not had prior contact with a sleep physician or prior exposure to CPAP therapy.

Exclusion Criteria: Subjects will be excluded for any of the following characteristics: -Non-English speaking

  • Illiterate
  • Sleep study is negative for sleep apnea (apnea-hypopnea index < 5 events/hr)
  • Subject does not undergo CPAP titration during the in-laboratory polysomnogram
  • Subject does not have a working telephone number
  • Poor eyesight or hearing
  • Dementia

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Enhanced education and Enhanced follow up

Usual education and Usual follow up

Enhanced education and Usual follow up

Usual education with Enhanced follow up

Arm Description

Subjects will watch a short video and will be contacted by an MD by phone

Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and will be contacted by a sleep center staff member by phone

Subjects will watch a short video immediately prior to the initiation of the in-laboratory polysomnogram and will be contacted by sleep center non-MD staff member by phone

Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and contacted by an MD by phone

Outcomes

Primary Outcome Measures

CPAP Therapy Adherence
Subject use of CPAP device will be monitored electronically. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to in-laboratory split night polysomnogram (sleep study) and initiation of CPAP therapy, and CPAP adherence rates of the two groups will be compared and reported.

Secondary Outcome Measures

Subject compliance with sleep clinic appointment
Subjects will be randomized to receive a reminder call for follow up clinic appointment either from MD or staff, and the compliance rates of the two groups will be compared based on call type and educational intervention type.
Patient Knowledge About Sleep Apnea and CPAP Therapy
Subjects will be administered 2 questionnaires which measure knowledge about their condition, both before and after the in-laboratory split night polysomnogram (sleep study). The scores of the two questionnaires will be combined for both test administrations. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to sleep study and initiation of CPAP therapy, and the change in the combined questionnaire scores of the two groups will be compared and reported.
Patient Satisfaction With the in-laboratory split night polysomnogram
Subjects will be administered 2 questionnaires which measure their mood and well-being, both before and after the in-laboratory split night polysomnogram. The questionnaires will be scored and the scores for each subject will be combined at both testing administrations. On the night of the in-laboratory polysomnogram subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to the initiation of the polysomnogram and initiation of CPAP therapy, and the change in the combined questionnaire scores of the two groups will be compared and reported.
CPAP Therapy Adherence
Subjects will be randomized to receive a reminder call for follow up sleep clinic appointment either from MD or non-MD sleep center staff, and the compliance rates of the two groups will be compared based on call type and educational intervention type.

Full Information

First Posted
August 5, 2014
Last Updated
March 2, 2017
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02553694
Brief Title
Sleep Apnea Video Education for CPAP (SAVE-CPAP)
Acronym
SAVE-CPAP
Official Title
Impact of a Short Educational Video on OSA Patient Satisfaction, Knowledge and Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine how satisfied patients are when undergoing an overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what factors affect obstructive sleep apnea (OSA) treatment use.
Detailed Description
The effects of educational interventions on subject compliance, satisfaction, and knowledge of their condition will be examined through the use of video vs pamphlet and MD vs staff contact for follow-up visit reminder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA, Apnea

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced education and Enhanced follow up
Arm Type
Experimental
Arm Description
Subjects will watch a short video and will be contacted by an MD by phone
Arm Title
Usual education and Usual follow up
Arm Type
Active Comparator
Arm Description
Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and will be contacted by a sleep center staff member by phone
Arm Title
Enhanced education and Usual follow up
Arm Type
Experimental
Arm Description
Subjects will watch a short video immediately prior to the initiation of the in-laboratory polysomnogram and will be contacted by sleep center non-MD staff member by phone
Arm Title
Usual education with Enhanced follow up
Arm Type
Experimental
Arm Description
Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and contacted by an MD by phone
Intervention Type
Other
Intervention Name(s)
Enhanced education
Intervention Description
Investigator created video to help educate subject before the in-laboratory split night polysomnogram. The subject will watch the short video immediately prior to the initiation of the in-laboratory polysomnogram.
Intervention Type
Other
Intervention Name(s)
Usual education
Intervention Description
Usual education by American Academy of Sleep Medicine (AASM)- created educational pamphlets
Intervention Type
Other
Intervention Name(s)
Usual follow up
Intervention Description
MD will follow up by phone after the in-laboratory split night polysomnogram
Intervention Type
Other
Intervention Name(s)
Enhanced follow up
Intervention Description
Sleep center non-MD staff member will follow up by phone after the in-laboratory split night polysomnogram
Primary Outcome Measure Information:
Title
CPAP Therapy Adherence
Description
Subject use of CPAP device will be monitored electronically. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to in-laboratory split night polysomnogram (sleep study) and initiation of CPAP therapy, and CPAP adherence rates of the two groups will be compared and reported.
Time Frame
30 days post in-lab split night polysomnogram
Secondary Outcome Measure Information:
Title
Subject compliance with sleep clinic appointment
Description
Subjects will be randomized to receive a reminder call for follow up clinic appointment either from MD or staff, and the compliance rates of the two groups will be compared based on call type and educational intervention type.
Time Frame
within 3 months after the in-laboratory split night polysomnogram
Title
Patient Knowledge About Sleep Apnea and CPAP Therapy
Description
Subjects will be administered 2 questionnaires which measure knowledge about their condition, both before and after the in-laboratory split night polysomnogram (sleep study). The scores of the two questionnaires will be combined for both test administrations. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to sleep study and initiation of CPAP therapy, and the change in the combined questionnaire scores of the two groups will be compared and reported.
Time Frame
1 day post in-laboratory split night polysomnogram
Title
Patient Satisfaction With the in-laboratory split night polysomnogram
Description
Subjects will be administered 2 questionnaires which measure their mood and well-being, both before and after the in-laboratory split night polysomnogram. The questionnaires will be scored and the scores for each subject will be combined at both testing administrations. On the night of the in-laboratory polysomnogram subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to the initiation of the polysomnogram and initiation of CPAP therapy, and the change in the combined questionnaire scores of the two groups will be compared and reported.
Time Frame
1 day post in-laboratory split night polysomnogram
Title
CPAP Therapy Adherence
Description
Subjects will be randomized to receive a reminder call for follow up sleep clinic appointment either from MD or non-MD sleep center staff, and the compliance rates of the two groups will be compared based on call type and educational intervention type.
Time Frame
1 month post sleep clinic visit or the date of the missed sleep clinic visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged > 18 years of age who are referred to the University of Chicago sleep laboratory for split-night polysomnography by a non-sleep physician and who have a consultation appointment with a sleep physician following the appointment Have not had prior contact with a sleep physician or prior exposure to CPAP therapy. Exclusion Criteria: Subjects will be excluded for any of the following characteristics: -Non-English speaking Illiterate Sleep study is negative for sleep apnea (apnea-hypopnea index < 5 events/hr) Subject does not undergo CPAP titration during the in-laboratory polysomnogram Subject does not have a working telephone number Poor eyesight or hearing Dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babak Mokhlesi, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21253882
Citation
Kohli P, Balachandran JS, Malhotra A. Obstructive sleep apnea and the risk for cardiovascular disease. Curr Atheroscler Rep. 2011 Apr;13(2):138-46. doi: 10.1007/s11883-011-0161-8.
Results Reference
background
PubMed Identifier
22005190
Citation
Metabolic disorders associated with obstructive sleep apnea in adults. Adv Cardiol. 2011;46:67-138. doi: 10.1159/000325106. Epub 2011 Oct 13.
Results Reference
background
PubMed Identifier
23493772
Citation
Balachandran JS, Yu X, Wroblewski K, Mokhlesi B. A brief survey of patients' first impression after CPAP titration predicts future CPAP adherence: a pilot study. J Clin Sleep Med. 2013 Mar 15;9(3):199-205. doi: 10.5664/jcsm.2476.
Results Reference
background
PubMed Identifier
28667231
Citation
Guralnick AS, Balachandran JS, Szutenbach S, Adley K, Emami L, Mohammadi M, Farnan JM, Arora VM, Mokhlesi B. Educational video to improve CPAP use in patients with obstructive sleep apnoea at risk for poor adherence: a randomised controlled trial. Thorax. 2017 Dec;72(12):1132-1139. doi: 10.1136/thoraxjnl-2017-210106. Epub 2017 Jun 30.
Results Reference
derived

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Sleep Apnea Video Education for CPAP (SAVE-CPAP)

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