Improving the Frequency and Quality of Sleep Apnea Care Management

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT01916655

Run by

VA Office of Research and Development

People needed

360

Starts

2015-08-03

Expected to finish

2018-03-30

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The project will have a 4-year timeline. Patients and providers at both the VA Pulmonary Sleep Clinic will participate in this prospective randomized clinical trial. Patients will participate by completing written informed consent, agreeing to be randomized, completing a baseline assessment, participating in the study interventional protocol, and completing follow-up assessments up to one-year post-intervention. The intent is to recruit a study population that is fairly representative of the overall VASDHS population of patients diagnosed with OSA. To this end, inclusion criteria are designed to be as inclusive as possible and are operationalized as follows:
• age > 18 years;
• confirmed diagnosis of OSA;
• being newly prescribed CPAP therapy; and
• having chronic symptoms as noted on screening symptom checklist. OSA diagnosis by the Sleep Clinic has been and is currently consistent with published consensus statements49 that CPAP treatment is indicated when the apnea-hypopnea index (AHI, number of apneas + hypopneas per hour of sleep) is either (1) greater than or equal to 15, or (2) between 5 and 15 AND accompanied by documented sleep apnea symptoms, including excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, and documented cardiovascular diseases. Because mild OSA symptoms are at best modestly correlated with AHI, the research study will focus on patients with moderate to severe sleep apnea, and therefore inclusion criteria will require AHI > 15.

You may not qualify if…

• Exclusion criteria include cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30);
• 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
• 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 (i.e., clinical needs of patient outweighs needs of research study). No exclusion criteria or any other study design elements will be used directly or indirectly to restrict study participation by women, members of minority groups, or primary language. Because men have a greater risk for OSA (and are identified and diagnosed at a greater rate) than women, we anticipate a final sample that reflects the OSA base rate differences on sex. Some minority groups are thought to have higher OSA prevalence rates than Caucasians, so assuming they are being screened/diagnosed at the same rates as Caucasians, we expect minority groups to be included in the study at levels that reflect those rates.

Where it is running

• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States

Full record on ClinicalTrials.gov

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