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
  Purpose

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.


Condition Intervention Phase
Sleep Apnea Syndromes
Behavioral: i-PAP
Behavioral: Usual Care (Standard Care)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • CPAP Adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of patient-centered collaborative care [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: i-PAP
Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care
Active Comparator: 2
Usual Care (Standard Care)
Behavioral: Usual Care (Standard Care)
Pre-determined clinic visits and telephone support

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662623

Locations
United States, California
Veterans Medical Research Foundation
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
Investigators
Principal Investigator: Carl J. Stepnowsky, PhD Veterans Medical Research Foundation
  More Information

No publications provided

Responsible Party: Carl Stepnowsky, PhD, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00662623     History of Changes
Other Study ID Numbers: HS-17246-01
Study First Received: April 16, 2008
Last Updated: July 6, 2010
Health Authority: United States: Federal Government

Keywords provided by Veterans Medical Research Foundation:
Chronic Obstructive Sleep Apnea
Sleep Apnea
Sleep Apnea Treatment

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014