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

March 2, 2017 updated by: University of Chicago

Impact of a Short Educational Video on OSA Patient Satisfaction, Knowledge and Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced education and Enhanced follow up
Subjects will watch a short video and will be contacted by an MD by phone
Other: Enhanced education
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.
Other: Usual follow up
MD will follow up by phone after the in-laboratory split night polysomnogram
Active Comparator: Usual education and Usual follow up
Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and will be contacted by a sleep center staff member by phone
Other: Usual education
Usual education by American Academy of Sleep Medicine (AASM)- created educational pamphlets
Other: Enhanced follow up
Sleep center non-MD staff member will follow up by phone after the in-laboratory split night polysomnogram
Experimental: Enhanced education and Usual follow up
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
Other: Enhanced education
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.
Other: Enhanced follow up
Sleep center non-MD staff member will follow up by phone after the in-laboratory split night polysomnogram
Experimental: Usual education with Enhanced follow up
Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and contacted by an MD by phone
Other: Usual follow up
MD will follow up by phone after the in-laboratory split night polysomnogram
Other: Usual education
Usual education by American Academy of Sleep Medicine (AASM)- created educational pamphlets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP Therapy Adherence
Time Frame: 30 days post in-lab split night polysomnogram
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.
30 days post in-lab split night polysomnogram

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject compliance with sleep clinic appointment
Time Frame: within 3 months after the in-laboratory split night polysomnogram
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.
within 3 months after the in-laboratory split night polysomnogram
Patient Knowledge About Sleep Apnea and CPAP Therapy
Time Frame: 1 day post in-laboratory split night polysomnogram
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.
1 day post in-laboratory split night polysomnogram
Patient Satisfaction With the in-laboratory split night polysomnogram
Time Frame: 1 day post 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.
1 day post in-laboratory split night polysomnogram
CPAP Therapy Adherence
Time Frame: 1 month post sleep clinic visit or the date of the missed sleep clinic visit
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.
1 month post sleep clinic visit or the date of the missed sleep clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Babak Mokhlesi, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB14-0198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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