Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Phase 2

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Behavioral: Usual Care (Standard Care); Behavioral: i-PAP

• Registration Number: NCT00662623
• Lead Sponsor: Veterans Medical Research Foundation

Brief Summary

The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.

Detailed Description

Poor treatment adherence with CPAP therapy is well-documented. Set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial-Usual Care patients (control) versus i-PAP patients (intervention). An important empirical-methodological advantage of the project is the objective measurement of CPAP adherence, which is measured by internal microprocessor as the "amount of time CPAP is used at the prescribed pressure." This objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-PAP intervention was designed around this central feature.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-21
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age > 18 years
• confirmed diagnosis of OSA
• being newly prescribed CPAP therapy
• having chronic symptoms as noted on screening symptom checklist
• fluency in English

Exclusion Criteria

• cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30)
• residence in a geographical area outside of San Diego County
• fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
• significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Usual Care (Standard Care)	Usual Care (Standard Care)
1	i-PAP	-

Primary Outcome Measures

Name	Time	Method
CPAP Adherence	4 months

Secondary Outcome Measures

Name	Time	Method
Quality of patient-centered collaborative care	4 months

Trial Locations

Locations (1)

Veterans Medical Research Foundation; 🇺🇸 San Diego, California, United States