Peer-Driven Intervention for Sleep Apnea

NCT02056002 | Unknown DMC

• 2 other identifiers: R-IHS-1306-02505PCORI
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

Brief 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

Obstructive Sleep Apnea

Keywords

Peer-driven intervention; Interactive voice response system; Continuous Positive Airway Pressure therapy and adherence

Outcome Measures

Primary Outcomes (1)

• Patient rating of sleep-specific services (Usual Care, Peer Buddy System)

  Patients will rate their global satisfaction of how satisfied they are with the care received from their sleep physician and sleep center on a 5-point scale: very satisfied, satisfied, neutral, dissatisfied, very dissatisfied

  Day 180

Secondary Outcomes (14)

• Patient Assessment of Care for Chronic Conditions (PACIC) ( Usual Care, Peer Buddy System)

  Day 180

• Client perception of care coordination (CPCQ) (Usual Care, Peer Buddy System)

  Day 180

• Consumer Assessment of Health Plans Survey (CAHPS v4.0) item (Usual Care, Peer Buddy System)

  Day 180

• CPAP Adherence downloads (Peer Buddy System)

  Day 30, Day 90, Day 180

• Patient Activation Measure (PAM) (Peer Buddy System)

  Baseline, Day 90, Day 180

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

* Standard CPAP educational training * Educational Brochures * Educational DVD videos mailed to participant

Other: Usual Care

Peer-Buddy System

EXPERIMENTAL

* 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

Other: Peer-Buddy System

Interventions

Usual Care OTHER

\- Standard CPAP educational training

Usual Care

Peer-Buddy System OTHER

* 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

Also known as: Peer-Driven Intervention

Peer-Buddy System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obstructive Sleep Apnea
• years of age
• Availability of cell or other reliable phone line
• Adherent to CPAP therapy ( greater than 4 hours per night of CPAP use)
• Willing to meet with subject on 2 occasions in-person
• Has a cell or other reliable telephone line and able to converse with subject on 8 occasions over the first 3 months and be available subsequently for a 3 month period on an as-needed basis
• Willing to undergo 2 training and orientation sessions with the Principal Investigator and research staff followed by a mock patient interaction session.

You may not qualify if:

• Central sleep apnea
• Participation in another intervention-based research study
• Patient's primary care provider refuses patient participation for medical instability
• Central sleep apnea
• Participation in another intervention-based research study
• Patient's primary care provider refuses patient participation for medical instability
• Patients suffering from major depression or other major psychiatric illness
• Shift-worker or frequent out of town traveler
• Unwilling to participate in orientation and training session or unable to "graduate" from the mock patient interaction session with study staff

Sponsors & Collaborators

• University of Arizona: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Arizona Center for Sleep Disorders

Tucson, Arizona, 85724, United States

Location

Related Publications (2)

• Parthasarathy S, Wendel C, Haynes PL, Atwood C, Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med. 2013 Jun 15;9(6):543-50. doi: 10.5664/jcsm.2744.

  PMID: 23772186 BACKGROUND

• Parthasarathy S, Wendel C, Grandner MA, Haynes PL, Guerra S, Combs D, Quan SF. Peer-Driven Intervention for Care Coordination and Adherence Promotion for Obstructive Sleep Apnea: A Randomized, Parallel-Group Clinical Trial. Am J Respir Crit Care Med. 2025 Feb;211(2):248-257. doi: 10.1164/rccm.202309-1594OC.

  PMID: 39441133 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sairam Parthasarathy, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 5, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 5, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)