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Long Term Efficacy of Education Programme on Continuous Positive Airway Pressure Treatment

Primary Purpose

Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Theory based education and brief motivation interview
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Apnea, Obstructive focused on measuring Long-term efficacy, Education programme, Adherence, OSA, CPAP

Eligibility Criteria

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

Inclusion Criteria:

-All 100 subjects recruited in our on-going RCT (IRB no. UW10-177)(ClinicalTrials.gov identifier no. NCT01173406) will be invited to participate in this extended study.

Exclusion Criteria:

-Unable to obtain the written informed consent

Sites / Locations

  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Extended Education

Standard education

Arm Description

Standard education programme as described above, Plus Face-to-face session (Part 1: Knowledge Enhancement Session, Part 2: Brief Motivation Interview Session) after the morning of CPAP titration Follow-up phone call would be arranged within 1 week after using CPAP. Video, slides and booklets would be used as education media.

- Each subject will receive advice from Sleep Lab staff on the need for CPAP treatment, and the care of CPAP device and mask.

Outcomes

Primary Outcome Measures

CPAP usage
It is to assess objective CPAP usage at 1 year after receiving CPAP education.

Secondary Outcome Measures

To evaluate the treatment outcomes of CPAP therapy on neuropsychologic aspects
To evaluate the treatment outcomes of CPAP therapy on neuropsychologic aspects such as the change in Epworth Sleepiness Score

Full Information

First Posted
September 1, 2011
Last Updated
October 18, 2013
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01428921
Brief Title
Long Term Efficacy of Education Programme on Continuous Positive Airway Pressure Treatment
Official Title
Long-term Efficacy of Extended Education Programme on Improving Treatment Adherence to Continuous Positive Airway Pressure in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 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
Obstructive sleep apnea (OSA) is a common sleep disorders associated with excessive daytime sleepiness and cardiovascular disease. Continuous positive airway pressure (CPAP) therapy is an effective standard treatment and is widely prescribed for patients with OSA. Successful CPAP treatment has also been shown to improve cognitive, cardiovascular and metabolic function. Sustainable CPAP treatment would alleviate the substantial cost burden of health-related consequences of untreated OSA. However, the use of CPAP for such patients is disappointingly low and limits the effectiveness of treatment. Early CPAP education and follow up have shown to be very important in helping subjects to handle side-effects or problems associated with the use of CPAP. Good education program at the initial phase of using CPAP is essentially affected the acceptance and adherence of CPAP therapy. Good CPAP adherence is not only medically essential to patients' health but also economically importance to society by alleviating the substantial cost burden of health-related consequences. To the best of our knowledge, there is no randomized clinical trial (RCT) to prove the long-term efficacy of extended education program on improving continuous positive airway pressure use and its treatment outcomes. The primary purpose of this study is to assess the long-term efficacy of our on-going RCT which is an extended education program on improving CPAP compliance. The investigators hypothesize that the application of both MI technique and SCT-based extended education program at the initial phase of using CPAP also would enhance CPAP adherence even after one year of attending education class.
Detailed Description
Obstructive sleep apnea (OSA) is a common disease characterized by recurrent episodic collapse of the upper airway during sleep. It affects 4-5% of the middle-aged population. Continuous positive airway pressure (CPAP) is an effective treatment to relieve the repetitive upper airway obstruction during sleep, and to improve cognitive, cardiovascular and metabolic function. However, compliance to CPAP treatment has been less than ideal which limits its effectiveness. Sustained CPAP treatment would alleviate the substantial cost burden of health-related consequences of untreated OSA. Early CPAP education and follow up have been shown to be very important in helping subjects to handle side-effects or problems associated with the use of CPAP. However, all current randomized controlled trials only evaluated its short-term efficacy for not more than 6months. Only one retrospective observational study assessed the longer term (1 year) effect of an education program by assessing patients' re-attendance rate of CPAP clinic. However, this study suffers from the residual effects of confounders. Therefore, the investigators need long term assessment of education program on CPAP compliance based on properly conducted randomized control trial. Our team has developed a theory-based behavioral education program to improve CPAP compliance. It utilizes social cognitive theory (SCT) and motivation interviewing (MI) which are popularly used theory-based education strategies and have been widely adopted and shown to be more effective than the traditional approach in health education programs. However, such programs have not been examined the longer term effect of education program in OSA patients. The investigators have recently started a RCT that assesses the 3-month effect of the program. To date, the investigators have recruited 36 subjects in 5 months. The subject recruitment is conservatively expected to be completed by July 2011. By the time when the review process of this proposal is completed, most of these subject should have been on treatment by 1 year. Hence, it is very timely for us to catch up this group of subjects for assessing the long-term effect of our education program. In additional, our team is highly experienced in the management of OSA patients. The investigators have recently demonstrated that the use of CPAP on the improvement cardiovascular and metabolic functions. Currently, the investigators are conducting a randomized controlled trial "Education and CPAP" (IRB no. UW10-177)(NCT01173406), which is to assess the short-term (3-months) efficacy of extended education program, which uses the concepts of SCT and MI. To the best of our knowledge, there is no randomized study from other investigators on the long-term efficacy of CPAP education intervention (either using traditional or theory-based education strategy). This proposed study is to assess the long-term efficacy of our current on-going extended education program on improving CPAP compliance on Chinese subjects with OSA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Long-term efficacy, Education programme, Adherence, OSA, CPAP

7. Study Design

Primary Purpose
Supportive Care
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
Extended Education
Arm Type
Experimental
Arm Description
Standard education programme as described above, Plus Face-to-face session (Part 1: Knowledge Enhancement Session, Part 2: Brief Motivation Interview Session) after the morning of CPAP titration Follow-up phone call would be arranged within 1 week after using CPAP. Video, slides and booklets would be used as education media.
Arm Title
Standard education
Arm Type
No Intervention
Arm Description
- Each subject will receive advice from Sleep Lab staff on the need for CPAP treatment, and the care of CPAP device and mask.
Intervention Type
Behavioral
Intervention Name(s)
Theory based education and brief motivation interview
Other Intervention Name(s)
Education program, CPAP adherence
Intervention Description
Standard education programme as described above, Plus Face-to-face session (Part 1: Knowledge Enhancement Session, Part 2: Brief Motivation Interview Session) after the morning of CPAP titration Follow-up phone call would be arranged within 1 week after using CPAP. Video, slides and booklets would be used as education media.
Primary Outcome Measure Information:
Title
CPAP usage
Description
It is to assess objective CPAP usage at 1 year after receiving CPAP education.
Time Frame
1 year after recieving CPAP education
Secondary Outcome Measure Information:
Title
To evaluate the treatment outcomes of CPAP therapy on neuropsychologic aspects
Description
To evaluate the treatment outcomes of CPAP therapy on neuropsychologic aspects such as the change in Epworth Sleepiness Score
Time Frame
at 1 year after recieving CPAP education

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -All 100 subjects recruited in our on-going RCT (IRB no. UW10-177)(ClinicalTrials.gov identifier no. NCT01173406) will be invited to participate in this extended study. Exclusion Criteria: -Unable to obtain the written informed consent
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
Country
Hong Kong

12. IPD Sharing Statement

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Long Term Efficacy of Education Programme on Continuous Positive Airway Pressure Treatment

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