Back to resultsEducation Programme on Continuous Positive Airway Pressure Treatment
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
CPAP education
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Continuous Positive Airway Pressure treatment, Adherence, Education
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or over.
- Newly diagnosed of OSA and will be starting CPAP therapy
Exclusion Criteria:
- Not suitable for CPAP therapy
- Previously received CPAP therapy
- Possesses restrictive and obstructive pulmonary diseases
- Possesses hypoventilation
- Under unstable health conditions
- pregnant
- History of psychiatric illness
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Standard care (SC)
Extended education (ME+SC)
Arm Description
Standard care
Motivational enhancement education + Standard care
Outcomes
Primary Outcome Measures
CPAP usage
To examine the efficacy of an education programme in enhancing the adherence of using CPAP.
Secondary Outcome Measures
Daytime Sleepiness
To examine the efficacy of an education programme in enhancing the improvement in OSA-related health outcomes
Full Information
NCT ID
NCT01173406
First Posted
July 27, 2010
Last Updated
October 18, 2013
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01173406
Brief Title
Education Programme on Continuous Positive Airway Pressure Treatment
Official Title
The Efficacy of a Brief Motivational Enhancement Education Programme on Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine whether an education programme would enhance continuous positive airway pressure (CPAP) adherence.
Detailed Description
Obstructive sleep apnoea (OSA) is a common sleep disorders associated with excessive daytime sleepiness and cardiovascular disease. It is prevalent both in populations of western and eastern countries. Continuous positive airway pressure (CPAP) therapy is an effective standard treatment and is widely prescribed for patients with OSA. However, the use of CPAP for such patients is disappointingly low. Low patient CPAP adherence limits the effectiveness of treatment. To determine whether there is a need for an extended education programme for the OSA patient in order to improve CPAP usage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Continuous Positive Airway Pressure treatment, Adherence, Education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care (SC)
Arm Type
Sham Comparator
Arm Description
Standard care
Arm Title
Extended education (ME+SC)
Arm Type
Active Comparator
Arm Description
Motivational enhancement education + Standard care
Intervention Type
Behavioral
Intervention Name(s)
CPAP education
Intervention Description
Standard CPAP education plus an session and one telephone follow up
Primary Outcome Measure Information:
Title
CPAP usage
Description
To examine the efficacy of an education programme in enhancing the adherence of using CPAP.
Time Frame
12-week
Secondary Outcome Measure Information:
Title
Daytime Sleepiness
Description
To examine the efficacy of an education programme in enhancing the improvement in OSA-related health outcomes
Time Frame
12-week
Other Pre-specified Outcome Measures:
Title
Self-efficacy measure for Sleep Apnea
Description
To examine the efficacy of an education programe in enhancing improvement in adherence-related cognitions
Time Frame
12-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or over.
Newly diagnosed of OSA and will be starting CPAP therapy
Exclusion Criteria:
Not suitable for CPAP therapy
Previously received CPAP therapy
Possesses restrictive and obstructive pulmonary diseases
Possesses hypoventilation
Under unstable health conditions
pregnant
History of psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes YK Lai, MSc
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong Island
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
24810282
Citation
Lai AYK, Fong DYT, Lam JCM, Weaver TE, Ip MSM. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial. Chest. 2014 Sep;146(3):600-610. doi: 10.1378/chest.13-2228.
Results Reference
derived
PubMed Identifier
24051110
Citation
Lai AY, Fong DY, Lam JC, Weaver TE, Ip MS. Linguistic and psychometric validation of the Chinese version of the self-efficacy measures for sleep apnea questionnaire. Sleep Med. 2013 Nov;14(11):1192-8. doi: 10.1016/j.sleep.2013.04.023. Epub 2013 Sep 16.
Results Reference
derived
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Education Programme on Continuous Positive Airway Pressure Treatment
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