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Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Veterans Medical Research Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00662623
First received: April 16, 2008
Last updated: July 6, 2010
Last verified: July 2010

April 16, 2008
July 6, 2010
April 2008
September 2010   (final data collection date for primary outcome measure)
CPAP Adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662623 on ClinicalTrials.gov Archive Site
Quality of patient-centered collaborative care [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Sleep Apnea Syndromes
  • Behavioral: i-PAP
    Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care
  • Behavioral: Usual Care (Standard Care)
    Pre-determined clinic visits and telephone support
  • Experimental: 1
    Intervention: Behavioral: i-PAP
  • Active Comparator: 2
    Usual Care (Standard Care)
    Intervention: Behavioral: Usual Care (Standard Care)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662623
HS-17246-01
No
Carl Stepnowsky, PhD, Veterans Medical Research Foundation
Veterans Medical Research Foundation
Not Provided
Principal Investigator: Carl J. Stepnowsky, PhD Veterans Medical Research Foundation
Veterans Medical Research Foundation
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP