Improving the Frequency and Quality of Sleep Apnea Care Management
1 other identifier
interventional
360
1 country
1
Brief Summary
OSA is a major chronic condition affecting the quality of life of millions of Americans. Per the Institute of Medicine new treatment adherence strategies are needed to help improve the quality of care, reduce social and economic costs, and help those with chronic conditions (such as OSA) live healthier and more productive lives through better management of their conditions. Using an mHealth tool to help deliver the investigators' Self-Management intervention and improve the frequency and quality of patient-provider communications is a central component of that discovery process.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
July 19, 2013
CompletedFirst Posted
Study publicly available on registry
August 5, 2013
CompletedStudy Start
First participant enrolled
August 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2018
CompletedResults Posted
Study results publicly available
September 6, 2019
CompletedSeptember 6, 2019
July 1, 2019
2.4 years
July 19, 2013
March 26, 2019
July 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive Airway Pressure Adherence
objective measurement of the amount of time PAP therapy is used at the prescribed pressure
2 month time point
Study Arms (3)
Usual Care
PLACEBO COMPARATORstandard and typical PAP (Positive Airway Pressure) educational and support protocol
Self-Management Care
EXPERIMENTALIndividualized self-management educational and support protocol
Self-Management Mobile Care
EXPERIMENTALIndividualized self-management educational and support protocol delivered in part by mobile health tool
Interventions
Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy
Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone
standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
Eligibility Criteria
You may qualify if:
- age \> 18 years;
- confirmed diagnosis of OSA;
- being newly prescribed CPAP therapy; and
You may not qualify if:
- residence in a geographical area outside of San Diego County (which could make some necessary face-to-face contact difficult);
- fatal comorbidity (life expectancy less than 6 months as indicated by treating physician);
- significant documented substance/chemical abuse; or
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carl J. Stepnowsky, PhD
- Organization
- VA San Diego Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Carl J Stepnowsky, PhD
VA San Diego Healthcare System, San Diego, CA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2013
First Posted
August 5, 2013
Study Start
August 3, 2015
Primary Completion
December 30, 2017
Study Completion
March 30, 2018
Last Updated
September 6, 2019
Results First Posted
September 6, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share