Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Automated Management (AM).
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Enhancing Positive Airway Pressure (PAP) Adherence Among Spanish-Speaking Hispanic Adults With Obstructive Sleep Apnea (OSA)
Overview
This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanic adults, 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 Hispanic adults, a group with known PAP outcomes disparities. This study will assess the feasibility, usability and effectiveness of a linguistically and culturally adapted 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, interactive communication is algorithmic based on PAP use and behavioral profiles defined at baseline. The innovative, technology-based intervention is 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 PAP management that may mitigate known PAP adherence disparities for minority adults with OSA. If effective for PAP adherence, these strategies may alter OSA care paradigms, improve outcomes and associated healthcare costs, and reduce disparities.
Interventions
- Behavioral Automated Management (AM)
A tele-management intervention that will deliver text messages to participants via a bot - a computer program that simulates human outreach activity. Programmed 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.
Primary outcome measures
- Patient Satisfaction [Time frame: 6 months]
- Acceptability [Time frame: 6 months]
- Appropriateness [Time frame: 6 months]
Secondary outcome measures (2)
- Recruitment Rate [Time frame: 6 months]
- Retention Rate [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Kaiser Permanent Southern California — Fontana
- University of Kansas Medical Center — Kansas City
- Geisinger — Danville
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT05618444 · 2022-0810 · 375-SR-25