Peer-Driven Intervention for Sleep Apnea (PCORI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Arizona
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT02056002
First received: February 3, 2014
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Other: Usual Care
Other: Peer-Buddy System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Peer-Driven Intervention as an Alternate Model of Care Delivery and Coordination for Sleep Apnea

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Patient rating of sleep-specific services (Usual Care, Peer Buddy System) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Patient Assessment of Care for Chronic Conditions (PACIC) ( Usual Care, Peer Buddy System) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    Derived from AHRQ care coordination measures atlas, measures care that is patient-centered, includes collaborative goal setting; problem-solving and follow-up support within the past 6 months and consists of five sub scales addressing the patient activation, delivery system design, goal setting, problem solving, and follow-up/coordination.

  • Client perception of care coordination (CPCQ) (Usual Care, Peer Buddy System) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    A measure of coordination of health care from the AHRQ care coordination measures atlas that is useful for assessment and program evaluation of individual and provider units as well as research into patient experience and measurement of patient-focused care.

  • Consumer Assessment of Health Plans Survey (CAHPS v4.0) item (Usual Care, Peer Buddy System) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    Health plan member's satisfaction with care on 0 to 10 scale (0 is the "worst " and 10 is the "best health plan possible")

  • CPAP Adherence downloads (Peer Buddy System) [ Time Frame: Day 30, Day 90, Day 180 ] [ Designated as safety issue: No ]
    All CPAP devices have internal adherence monitoring which can be downloaded using a computer cable, smart card, SD chip or wireless transmission. The objective, adherence information as 'mask-on' time for 6 months, number of nights used, cumulative hours used, average hours of CPAP use per night, and average number of hours per day of CPAP use will be derived. The proportion of days in which CPAP use was at least 4 hr (Medicare criterion) will also be utilized.

  • Patient Activation Measure (PAM) (Peer Buddy System) [ Time Frame: Baseline, Day 90, Day 180 ] [ Designated as safety issue: No ]
    The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management

  • Self-efficacy measure for sleep apnea (SEMSA) ( Peer Buddy System) [ Time Frame: Baseline, Day 90, Day 180 ] [ Designated as safety issue: No ]
    SEMSA is a tool with strong psychometric properties and has the potential for identifying patient perceptions that may indicate those most likely to not adhere to treatment. There are 3 domains that contribute to global score: (a) Measure of perceived risk is rated on a 4-point scale ranging from very low to very high. (b) Outcome expectancies are surveyed by a 4-point scale seeking responses (ranging from not at all true to very true) to statements of potential general outcomes if CPAP is or was not used. (c) Self-efficacy, or the volition to use CPAP therapy, is evaluated by asking the respondent to rate on a 4-point scale the level of validity (ranging from 'not at all true' to 'very true') of statements regarding their confidence in using CPAP.

  • Functional Outcomes of Sleep Questionnaire (FOSQ) ( Peer Buddy System) [ Time Frame: Baseline, Day 90, Day 180 ] [ Designated as safety issue: No ]
    A condition-specific functional status measure designed to evaluate the impact of disorders of excessive sleepiness on activities of daily living. Lower global scores are associated with greater dysfunction. FOSQ has good to excellent test-retest reproducibility, internal consistency, with discriminate validity between those seeking medical attention for sleep disorders compared to normal subjects.

  • Psychomotor vigilance task (PVT) (Peer Buddy System) [ Time Frame: Baseline, Day 90, Day 180 ] [ Designated as safety issue: No ]
    PVT is a "video game" measure of an individual's (vigilance) readiness to detect and respond to certain specified small changes in a labile environment, conceptualized pragmatically within a visio-reactive framework. Essentially, a stop clock is set at zero and begins to suddenly and spontaneously run at various time points in multiple (5) trials. As soon as the subject notices the clock start to run, they click a button that registers their reaction time. The average reaction time to such multiple runs is calculated as a inverse function of the subjects' reaction time. A practice session is afforded before the real test is administered. This takes 5 minutes time.

  • Systolic and diastolic blood pressure (Peer buddy System) [ Time Frame: Baseline, Day 90, Day 180 ] [ Designated as safety issue: No ]
    measured by experienced staff following international guidelines.

  • Epworth sleepiness questionnaire ( Peer Buddy System) [ Time Frame: Baseline, Day 90, Day 180 ] [ Designated as safety issue: No ]
    A measure of sleepiness.

  • Driving Questionnaire (Usual Care, Peer Buddy System) [ Time Frame: Baseline, Day 180 ] [ Designated as safety issue: No ]
    Questionnaire regarding driving habits for patients with sleep apnea. If a motor vehicle accident was reported will need to provide documentation.

  • Body Mass Index (BMI) (Usual Care, Peer Buddy System) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A measure of body fat based on height and weight.

  • Patient Ratings Survey (Usual Care, Peer Buddy System) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    Satisfaction survey of care delivery compared between intervention and usual care.


Estimated Enrollment: 257
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care
  • Standard CPAP educational training
  • Educational Brochures
  • Educational DVD videos mailed to participant
Other: Usual Care
- Standard CPAP educational training
Other: Usual Care
- Educational Brochures
Other: Usual Care
- Educational DVD videos mailed to participant
Experimental: Peer-Buddy System
  • 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
  • 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 Name: Peer-Driven Intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Subject:

  • Obstructive Sleep Apnea
  • 18-85 years of age
  • Availability of cell or other reliable phone line

Inclusion Criteria for Peer Buddy:

  • 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.

Exclusion Criteria for Subject:

  • Central sleep apnea
  • Participation in another intervention-based research study
  • Patient's primary care provider refuses patient participation for medical instability

Exclusion Criteria for Peer Buddy:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056002

Contacts
Contact: Alexandra Valentin 520-626-4838 agv@email.arizona.edu
Contact: Chris Morton 520-626-4838 cjmorton@email.arizona.edu

Locations
United States, Arizona
University of Arizona Center for Sleep Disorders Recruiting
Tucson, Arizona, United States, 85724
Contact: Alexandra G Valentin    520-626-4838    agv@email.arizona.edu   
Contact: Chris J Morton    520-626-4838    cjmorton@email.arizona.edu   
Principal Investigator: Sairam Parthasarathy, MD         
Sponsors and Collaborators
University of Arizona
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: Sairam Parthasarathy, MD University of Arizona
  More Information

Publications:
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02056002     History of Changes
Other Study ID Numbers: R-IHS-1306-02505, PCORI
Study First Received: February 3, 2014
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Peer-driven intervention
Interactive voice response system
Continuous Positive Airway Pressure therapy and adherence

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 27, 2014