Sleep Apnea Video Education for CPAP (SAVE-CPAP)

Obstructive Sleep Apnea Clinical Trial

— SAVE-CPAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553694
• Other study ID #: IRB14-0198
• Status: Completed
• Phase: N/A
• First received: August 5, 2014
• Last updated: March 2, 2017
• Start date: July 2014
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• Usual education
Usual education by American Academy of Sleep Medicine (AASM)- created educational pamphlets
• Usual follow up
MD will follow up by phone after the in-laboratory split night polysomnogram
• Enhanced follow up
Sleep center non-MD staff member will follow up by phone after the in-laboratory split night polysomnogram

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View Citation

Lurie A. Metabolic disorders associated with obstructive sleep apnea in adults. Adv Cardiol. 2011;46:67-138. doi: 10.1159/000325106. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days post in-lab split night polysomnogram
Secondary	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.	within 3 months after the in-laboratory split night polysomnogram
Secondary	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.	1 day post in-laboratory split night polysomnogram
Secondary	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.	1 day post in-laboratory split night polysomnogram
Secondary	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.	1 month post sleep clinic visit or the date of the missed sleep clinic visit