Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
Primary Purpose
Sleep Apnea Syndromes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
i-PAP
Usual Care (Standard Care)
Sponsored by

About this trial
This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Chronic Obstructive Sleep Apnea, Sleep Apnea, Sleep Apnea Treatment
Eligibility 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
Sites / Locations
- Veterans Medical Research Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Usual Care (Standard Care)
Outcomes
Primary Outcome Measures
CPAP Adherence
Secondary Outcome Measures
Quality of patient-centered collaborative care
Full Information
NCT ID
NCT00662623
First Posted
April 16, 2008
Last Updated
May 12, 2016
Sponsor
Veterans Medical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00662623
Brief Title
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
Official Title
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Medical Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
Chronic Obstructive Sleep Apnea, Sleep Apnea, Sleep Apnea Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual Care (Standard Care)
Intervention Type
Behavioral
Intervention Name(s)
i-PAP
Intervention Description
Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care
Intervention Type
Behavioral
Intervention Name(s)
Usual Care (Standard Care)
Intervention Description
Pre-determined clinic visits and telephone support
Primary Outcome Measure Information:
Title
CPAP Adherence
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Quality of patient-centered collaborative care
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl J. Stepnowsky, PhD
Organizational Affiliation
Veterans Medical Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Medical Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
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