Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 16, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedMay 13, 2016
May 1, 2016
2.4 years
April 16, 2008
May 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CPAP Adherence
4 months
Secondary Outcomes (1)
Quality of patient-centered collaborative care
4 months
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORUsual Care (Standard Care)
Interventions
Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care
Eligibility Criteria
You may qualify if:
- age \> 18 years
- confirmed diagnosis of OSA
- being newly prescribed CPAP therapy
- having chronic symptoms as noted on screening symptom checklist
- fluency in English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Veterans Medical Research Foundation
San Diego, California, 92161, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl J. Stepnowsky, PhD
Veterans Medical Research Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study PI
Study Record Dates
First Submitted
April 16, 2008
First Posted
April 21, 2008
Study Start
April 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
May 13, 2016
Record last verified: 2016-05