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Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

Not Applicable
Recruiting
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
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Automated Management (AM)Automated Management (AM)Receipt of text-based behavioral intervention
Primary Outcome Measures
NameTimeMethod
Acceptability6 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 Satisfaction6 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.

Appropriateness6 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
NameTimeMethod
Recruitment Rate6 months

Recruitment Rate computed at the end of the trial

Retention Rate6 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

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