Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

NCT05618444 | Recruiting

• 1 other identifier: 2022-0810
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Obstructive Sleep Apnea

Keywords

positive airway pressure (PAP); adherence; Hispanic; tele-management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Recruitment Rate

  6 months

• Retention Rate

  6 months

Other Outcomes (8)

• Positive airway pressure (PAP) use from 3-6 months

  3-6 months

• PAP adherence based on modified Centers for Medicare & Medicaid Services (CMS) criteria

  6 months

• Patient Satisfaction

  1 month

Study Arms (2)

Automated Management (AM)

EXPERIMENTAL

Receipt of text-based behavioral intervention

Behavioral: Automated Management (AM)

Usual Care

NO INTERVENTION

Control group receiving usual care for obstructive sleep apnea

Interventions

Automated Management (AM) BEHAVIORAL

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.

Automated Management (AM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (4)

Kaiser Permanent Southern California

Fontana, California, 92335, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Geisinger

Danville, Pennsylvania, 17821, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Bruno Saconi, PhD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Saconi, PhD

CONTACT

5702148191; bsaconi@geisinger.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 16, 2022
• Study Start: October 15, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)