Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhancing Positive Positive Airway Pressure (PAP) Adherence Among Spanish-Speaking Hispanic Adults With Obstructive Sleep Apnea (OSA)

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Automated Management (AM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated Management (AM)<br>Receipt of text-based behavioral intervention | Behavioral: Automated Management (AM)<br>* 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.<br>|
| No Intervention: Usual Care<br>Control group receiving usual care for obstructive sleep apnea | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Satisfaction with quality of care and the components of care (e.g., feedback, frequency, duration), relevance of the care to the individual and their needs, and overall satisfaction with care. Assessed with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction. | 6 months | 
| Acceptability | Defined as the perception that a given treatment is agreeable, palatable, or satisfactory. Assessed with the Acceptability of Intervention Measure (AIM; 4 items, Likert, 1-5, where 1 = completely disagree and 5 = completely agree). Higher scores indicate higher acceptability. | 6 months | 
| Appropriateness | Defined as the perceived fit, relevance, or compatibility of a given treatment. Assessed with the Intervention Appropriateness Measure (IAM; 4 items, Likert, 1-5, where 1 = completely disagree and 5 = completely agree). Higher scores indicate higher appropriateness. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | Recruitment Rate computed at the end of the trial | 6 months | 
| Retention Rate | Retention Rate computed at the end of the trial | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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positive airway pressure (PAP), adherence, Hispanic, tele-management