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

NCT01428921 | Completed DMC

• 1 other identifier: UW11-044
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Long-term efficacy; Education programme; Adherence; OSA; CPAP

Outcome Measures

Primary Outcomes (1)

• CPAP usage

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

  1 year after recieving CPAP education

Secondary Outcomes (1)

• To evaluate the treatment outcomes of CPAP therapy on neuropsychologic aspects

  at 1 year after recieving CPAP education

Study Arms (2)

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.

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.

Interventions

Theory based education and brief motivation interview BEHAVIORAL

* 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.

Also known as: Education program, CPAP adherence

Extended Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to obtain the written informed consent

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Agnes YK Lai, MSc

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Technical Officer

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 5, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 21, 2013

Record last verified: 2013-10

Locations

HK (1)