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Peer-Buddy System for Obstructive Sleep Apnea (PCORI Trial)

N/A
Waitlist Available
Led By Sairam Parthasarathy, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30, day 90, day 180
Awards & highlights
No Placebo-Only Group

Summary

Fragmentation of care can lead to poor treatment adherence in patients with chronic medical conditions which can, in turn, lead to adverse health consequences, poor quality of life, and patient dissatisfaction. Poor treatment adherence may be due to lack of sufficient patient education, time delays in delivery of care, lack of adequate healthcare coordination, or difficulty accessing various healthcare providers across a front desk which serves as a "healthcare bottle-neck". Better efficiency in healthcare delivery, with greater connectivity through knowledgeable and trained peer volunteers and inexpensive cell-phones integrated by a smart telephone exchange may alleviate some of the care and communication burden faced by the healthcare system. Specifically, such community health education volunteers ("peer-buddies") who are experienced in managing their disease condition may be able to impart knowledge and confidence to a recently diagnosed patient in a much more personalized manner than that of a group therapy session. An additional important advantage is the peer-buddy's ability to relate to the patient in a manner consistent with their social, ethnic, and cultural believes without language barriers or differences that may stem from socioeconomic strata. We will use sleep apnea as an example condition to test the effect of a peer-buddy helper (combined with the universal availability of personal cell phones) on the problem of poor care coordination and treatment adherence to the "CPAP" treatment for sleep apnea. Sleep apnea is a very common condition that affects 7-12% of the US population, and if left untreated, can lead to poor health and even death through its effects on high blood pressure, heart disease, stroke, and motor vehicle accidents. Fortunately, CPAP therapy can lead to a 3-fold reduction in such consequences, but patient adherence to such CPAP treatment is generally poor. We have recently completed a small study that demonstrated improved usage of CPAP treatment by patients receiving help from a peer-buddy with excellent results. We propose to further enhance the "peer-buddy" community-volunteer concept in our proposed research by combining this with cell-phone technology and a telephone exchange that improves access to healthcare providers, technicians, and home care companies. We hope to show that active community participation by experienced "lay individuals" assisted by the universal availability of cheap cell-phones can improve the reach and effectiveness of our healthcare system in improving the health and well-being of our patients. If successful, such an innovative and community-based approach can be applied to other chronic medical conditions. Hypothesis #1: We hypothesize that patients in the peer-driven intervention with interactive voice response (PDI-IVR) group will experience a greater patient satisfaction (measured by Likert scale64,70 and PACIC71,72) and perception of care coordination (measured by CPCQ72,73) than patients in the usual care (control) group. Hypothesis #2: We hypothesize that patients in the PDI-IVR group will experience a greater CPAP adherence (measured by device download), patient activation (PAM), and self-efficacy (SEMSA) than patients in the usual care (control) group. Hypothesis #3: We hypothesize that patients in the PDI-IVR group will experience greater improvements in HR-QOL (measured by FOSQ) vigilance (psychomotor vigilance testing) and blood pressure than patients in the usual care (control) group.

Eligible Conditions
  • Obstructive Sleep Apnea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 90, day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 90, day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient rating of sleep-specific services (Usual Care, Peer Buddy System)
Secondary study objectives
Body Mass Index (BMI) (Usual Care, Peer Buddy System)
CPAP Adherence downloads (Peer Buddy System)
Client perception of care coordination (CPCQ) (Usual Care, Peer Buddy System)
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Peer-Buddy SystemExperimental Treatment1 Intervention
* Two 30-minute in person sessions with Peer Buddy * Standard CPAP training * Eight phone conversations with Peer Buddy over 3 months * Subsequent 3 months use of phone system to contact Peer Buddy as needed One Month Visit: -Home visit to collect CPAP information Three Month Visit: * Questionnaires * Psycho Motor Vigilance Test (PVT) "Video Game" * Collect CPAP information * Measure weight * Measure blood pressure Six Month Visit: * Questionnaires * PVT (Video game) * Collect CPAP information * Measure Weight * Measure Blood Pressure * Evaluate the program and Peer Buddy
Group II: Usual CareActive Control1 Intervention
* Standard CPAP educational training * Educational Brochures * Educational DVD videos mailed to participant

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
573 Previous Clinical Trials
27,077,870 Total Patients Enrolled
University of ArizonaLead Sponsor
534 Previous Clinical Trials
159,113 Total Patients Enrolled
Sairam Parthasarathy, MDPrincipal InvestigatorUniversity of Arizona
11 Previous Clinical Trials
461 Total Patients Enrolled
~31 spots leftby Nov 2025