Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Sleep Apnea Syndromes Clinical Trial

Official title:

Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662623
• Other study ID #: HS-17246-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 16, 2008
• Last updated: May 12, 2016
• Start date: April 2008
• Est. completion date: September 2010

Study information

• Verified date: May 2016
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes

Intervention

Behavioral:
• i-PAP
Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care
• Usual Care (Standard Care)
Pre-determined clinic visits and telephone support

Locations

Country	Name	City	State
United States	Veterans Medical Research Foundation	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP Adherence		4 months	No
Secondary	Quality of patient-centered collaborative care		4 months	No