Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Apnea Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

i-PAP

Intervention Type BEHAVIORAL

Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care

2

Usual Care (Standard Care)

Group Type ACTIVE_COMPARATOR

Usual Care (Standard Care)

Intervention Type BEHAVIORAL

Pre-determined clinic visits and telephone support

Interventions

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i-PAP

Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care

Intervention Type BEHAVIORAL

Usual Care (Standard Care)

Pre-determined clinic visits and telephone support

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No