Clinical trial NCT05618444: Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA
Official title: Enhancing Positive Positive Airway Pressure (PAP) Adherence Among Spanish-Speaking Hispanic Adults With Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: positive airway pressure (PAP)
adherence
Hispanic
tele-management
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2022-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 6 months
measure: Acceptability
timeFrame: 6 months
measure: Appropriateness
timeFrame: 6 months
Secondary outcomes:
measure: Recruitment Rate
timeFrame: 6 months
measure: Retention Rate
timeFrame: 6 months
Other outcomes:
measure: Positive airway pressure (PAP) use from 3-6 months
timeFrame: 3-6 months
measure: PAP adherence based on modified Centers for Medicare & Medicaid Services (CMS) criteria
timeFrame: 6 months
measure: Patient Satisfaction
timeFrame: 1 month
measure: Patient Satisfaction
timeFrame: 3 months
measure: Acceptability
timeFrame: 1 month
measure: Acceptability
timeFrame: 3 months
measure: Appropriateness
timeFrame: 1 month
measure: Appropriateness
timeFrame: 3 months
Locations:
city: Fontana
country: United States
facility: Kaiser Permanent Southern California
state: California
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Bruno Saconi, PhD
role: PRINCIPAL_INVESTIGATOR
References: