Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea

NCT03345524 | Unknown

• 2 other identifiers: 17098347171R56HL138377-01
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a prevalent condition that affects 7 to 12% of the US population and is characterized by repetitive collapse of the upper airway during sleep. Continuous positive airway pressure (CPAP) has been shown to be highly effective in the treatment of OSA, however, adherence is poor with up to 54% of patients being non-adherent to CPAP therapy by Medicare criteria, which has been attributed to inadequate patient education and support for CPAP therapy. Poor treatment adherence in patients with OSA can 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 cheap 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 OSA 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; OSA; Peer-Buddies; CPAP; CPAP Adherence

Outcome Measures

Primary Outcomes (1)

• Proportion of patients undergoing sleep study testing

  Difference between the proportion of patients in the peer-buddy arm from the proportion of patients in the conventional educational arm that follow-through and undergo sleep study testing.

  Baseline

Secondary Outcomes (1)

• CPAP Adherence downloads

  Day 30, Day 90, and Day 180

Other Outcomes (5)

• Functional Outcomes of Sleep Questionnaire (FOSQ)

  Baseline, Day 90, and Day 180

• Epworth Sleepiness Scale

  Baseline, Day 90, and Day 180

• Systolic Blood Pressure

  Baseline, Day 90, and Day 180

Study Arms (2)

Peer-buddy system

EXPERIMENTAL

Will meet with peer-buddy who will help with them with CPAP usage. Also will receive standard of care CPAP educational training

Other: Peer-Buddy System

Usual Care

ACTIVE COMPARATOR

Will receive educational material at the same frequency that those in the experimental arm. Will also receive standard of care CPAP educational training.

Other: Usual Care

Interventions

Peer-Buddy System OTHER

2-4 30-minute in person sessions with Peer Buddy (2 before and 2 after receiving CPAP) Standard of care CPAP educational training 8-10 phone conversations with Peer Buddy over 3 month period Subsequent 3 months use of phone system to contact Peer Buddy as needed

Peer-buddy system

Usual Care OTHER

Standard of care CPAP educational training Educational Brochures and DVD videos mailed to participants (12 times)

Usual Care

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referral for sleep study testing for possible OSA
• Medicaid and dual-eligible Medicare beneficiaries
• Household income in the bottom national quartile of household median income
• Adherent to CPAP therapy (greater than or equal to 4 hours per night of CPAP use)
• Willing to meet with peer-buddy on 2-4 occasions in-person
• Has a cell phone or other reliable telephone line
• Willing to undergo one-two training and orientation session(s) and pass a subsequent mock patient interaction

You may not qualify if:

• Central sleep apnea (CSA)
• Participation in another intervention-based research study
• Patient's primary care provider refuses patient participation for medical instability
• Central sleep apnea (CSA)
• Participation in another intervention-based research study
• Patient's primary care provider refuses patient participation for medical instability
• Major depression or other major psychiatric illness
• Shift-worker or frequent out of town traveler

Sponsors & Collaborators

• University of Arizona: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Related Publications (23)

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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

Central Study Contacts

Sairam Parthasarathy, MD

CONTACT

520-626-6109; sparthasarathy@deptofmed.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Will be blinded to subjects group assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: November 17, 2017
• Primary Completion: October 11, 2018
• Study Completion: October 11, 2018
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)