Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Behavioral: Automated Management (AM)
- Registration Number
- NCT05618444
- Lead Sponsor
- Geisinger Clinic
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Automated Management (AM) Automated Management (AM) Receipt of text-based behavioral intervention
- Primary Outcome Measures
Name Time Method Acceptability 6 months 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.
Patient Satisfaction 6 months 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.
Appropriateness 6 months 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.
- Secondary Outcome Measures
Name Time Method Recruitment Rate 6 months Recruitment Rate computed at the end of the trial
Retention Rate 6 months Retention Rate computed at the end of the trial
Trial Locations
- Locations (4)
Geisinger
🇺🇸Danville, Pennsylvania, United States
Kaiser Permanent Southern California
🇺🇸Fontana, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States