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| ID | Type | Description | Link |
|---|---|---|---|
| 375-SR-25 | Other Grant/Funding Number | American Academy of Sleep Medicine Foundation |
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| Name | Class |
|---|---|
| American Academy of Sleep Medicine | OTHER |
| University of Pennsylvania | OTHER |
| University of Kansas | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated Management (AM) | Experimental | Receipt of text-based behavioral intervention |
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| Usual Care | No Intervention | Control group receiving usual care for obstructive sleep apnea |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Recruitment Rate computed at the end of the trial | 6 months |
| Retention Rate | Retention Rate computed at the end of the trial |
| Measure | Description | Time Frame |
|---|---|---|
| Positive airway pressure (PAP) use from 3-6 months | Hours of PAP use per 24 hours | 3-6 months |
| PAP adherence based on modified Centers for Medicare & Medicaid Services (CMS) criteria | Adherence yes/no using ≥4 hours/night and ≥70% of nights |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexa Watach, PhD, RN | Contact | 570-271-8663 | awatach@nursing.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexa Watach, PhD, RN | Unniversity of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanent Southern California | Fontana | California | 92335 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 6 months |
| 6 months |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| Geisinger | Danville | Pennsylvania | 17821 | United States |
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| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |