Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

Purpose

This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanics, a group with known PAP outcomes disparities. This study will assess the feasibility of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with OSA.

Condition

  • Obstructive Sleep Apnea

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Spanish-speaking and reading - Self-identified Hispanic - Adults ≥ 18 years-old - Males and females - Moderate-severe OSA defined as AHI ≥15 events/hour using a hypopnea criterion of a 4% oxygen desaturation (AHI4%) - Expected availability for the duration of the study (6 months from date of randomization) - Ownership of smartphone with unlimited text messaging capability - Referred to PAP treatment and able and willing to be treated with PAP

Exclusion Criteria

  • Other sleep apnea or nocturnal respiratory insufficiency or failure diagnosis other than OSA established by polysomnogram (PSG) or home sleep apnea test (HSAT) - Requirement of supplemental oxygen or other non-invasive ventilation modality - Women referred to PAP because of new-onset OSA with pregnancy as PAP treatment may be time-limited (enrolled women who become pregnant during the trial and are already on PAP treatment will not be excluded) - Anticipated or scheduled bariatric surgery and/or referred to sleep evaluation by bariatric surgery

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Automated Management (AM) 		Receipt of text-based behavioral intervention
  • Behavioral: Automated Management (AM)
    A tele-management intervention that will deliver two-way messages to participants via a bot - a computer program that simulates human activity. Programmed AM messages will address evidence based intervention components for positive airway pressure (PAP) adherence, including PAP use awareness (tele-monitoring), support and troubleshooting, education, and brief motivational messaging.
No Intervention
Usual Care 		Control group receiving usual care for obstructive sleep apnea

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Geisinger Clinic

Study Contact

Bruno Saconi, PhD
5702148191
bsaconi@geisinger.edu

Detailed Description

This feasibility study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanics, a group with known PAP outcomes disparities. This study will assess the feasibility, usability and 6-month effectiveness of a linguistically and culturally adapted efficacious tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with obstructive sleep apnea (OSA) (N=50). A prospective, randomized, parallel group, unblinded, feasibility trial is proposed. AM is a tele-management strategy that includes evidence-based components for improving shorter-term PAP adherence consisting of education, support and troubleshooting, and brief targeted motivational enhancement delivered by tele-messaging. The automated two-way, interactive communication is algorithmic based on PAP use and behavioral profiles defined at baseline. The innovative, technology-based interventions are designed to ensure access to sustained care that overcomes barriers such as distance/geography, transportation limitations or lost work/productivity time. As such, AM can provide equitable access to quality long-term PAP management that may mitigate known PAP adherence disparities for minority adults with OSA. If effective for long-term PAP adherence, these strategies may alter OSA care paradigms, improve outcomes and associated healthcare costs, and reduce disparities.