Health TrialsbyHealthPanel

Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

ConditionObstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeisinger Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Spanish-speaking and reading

Self-identified Hispanic

Adults ≥ 18 years-old

Males and females

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Automated Management (AM)

    Behavioral

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Automated Management (AM)Experimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months
3

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.

Time frame
6 months

Secondary outcomes

1

Recruitment Rate

Recruitment Rate computed at the end of the trial

Time frame
6 months
2

Retention Rate

Retention Rate computed at the end of the trial

Time frame
6 months

Other outcomes

1

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

Hours of PAP use per 24 hours

Time frame
3-6 months
2

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

Adherence yes/no using ≥4 hours/night and ≥70% of nights

Time frame
6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Geisinger Clinic

Lead sponsor

American Academy of Sleep Medicine

Collaborator

University of Pennsylvania

Collaborator

University of Kansas

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: