Sleep Apnea, ObstructiveNCT01428921
Long Term Efficacy of Education Programme on Continuous Positive Airway Pressure Treatment
A study testing Theory based education and brief motivation interview in people with Sleep Apnea, Obstructive, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Theory based education and brief motivation interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- -Unable to obtain the written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Efficacy of Extended Education Programme on Improving Treatment Adherence to Continuous Positive Airway Pressure in Obstructive Sleep Apnea
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.
Read more
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Theory based education and brief motivation interview
- Keywords
- Long-term efficacy, Education programme, Adherence, OSA, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory based education and brief motivation interviewBehavioural
Also called Education program, CPAP adherence
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Extended Education | Experimental | * Standard education programme as described above,
* Plus
1. Face-to-face session (Part 1: Knowledge Enhancement Session, Part 2: Brief Motivation Interview Session) after the morning of CPAP titration
2. Follow-up phone call would be arranged within 1 week after using CPAP.
3. Video, slides and booklets would be used as education media. Receives: Behavioral: Theory based education and brief motivation interview |
| Standard education | No intervention | - Each subject will receive advice from Sleep Lab staff on the need for CPAP treatment, and the care of CPAP device and mask. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP usage
It is to assess objective CPAP usage at 1 year after receiving CPAP education.
Measured: 1 year after recieving CPAP education
Secondary outcomes (1)
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
Measured: at 1 year after recieving CPAP education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai Yuen Kwan Agnes, The University of Hong Kong
- Investigators
- Agnes YK Lai, MSc, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428921
- Sponsor's protocol ID
- UW11-044
- Status last verified
- Oct 2013
- First submitted
- 1 Sep 2011
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Extended Education Programme on Improving Treatment Adherence to Continuous Positive Airway Pressure in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01428921
- Acronym / sponsor ID
- UW11-044
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Long-term efficacy, Education programme, Adherence, OSA, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Education | Experimental | Behavioral: Theory based education and brief motivation interview* Standard education programme as described above, * Plus 1. Face-to-face session (Part 1: Knowledge Enhancement Session, Part 2: Brief Motivation Interview Session) after the morning of CPAP titration 2. Follow-up phone call would be arranged within 1 week after using CPAP. 3. Video, slides and booklets would be used as education media. |
| Standard education | No intervention | –- Each subject will receive advice from Sleep Lab staff on the need for CPAP treatment, and the care of CPAP device and mask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (1 listed)
- -Unable to obtain the written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theory based education and brief motivation interviewAlso: Education program, CPAP adherence* Standard education programme as described above, * Plus 1. Face-to-face session (Part 1: Knowledge Enhancement Session, Part 2: Brief Motivation Interview Session) after the morning of CPAP titration 2. Follow-up phone call would be arranged within 1 week after using CPAP. 3. Video, slides and booklets would be used as education media. | Behavioural | Extended Education |
Primary outcome
CPAP usage
Time frame: 1 year after recieving CPAP education
It is to assess objective CPAP usage at 1 year after receiving CPAP education.
1 secondary outcome
To evaluate the treatment outcomes of CPAP therapy on neuropsychologic aspects
Time frame: at 1 year after recieving CPAP education
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes YK Lai, MSc principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theory based education and brief motivation interview in people with Sleep Apnea, Obstructive, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP usage (time frame: 1 year after recieving CPAP education). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2013.