Peer-Driven Intervention for Sleep Apnea

NCT02056002 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2017-07-05

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Usual Care

\- Standard CPAP educational training

OTHER

Peer-Buddy System

* Two 30-minute in person sessions with Peer Buddy * Standard CPAP educational 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

OTHER

Usual Care

\- Educational Brochures

OTHER

Usual Care

\- Educational DVD videos mailed to participant

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • University of Arizona

    lead OTHER

Principal Investigators

  • Sairam Parthasarathy, MD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02056002 on ClinicalTrials.gov