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Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated Management (AM)
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring positive airway pressure (PAP), adherence, Hispanic, tele-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Kaiser Permanent Southern California
  • University of Kansas Medical Center
  • Geisinger
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Automated Management (AM)

Usual Care

Arm Description

Receipt of text-based behavioral intervention

Control group receiving usual care for obstructive sleep apnea

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Recruitment Rate
Recruitment Rate computed at the end of the trial
Retention Rate
Retention Rate computed at the end of the trial

Full Information

First Posted
November 3, 2022
Last Updated
June 20, 2023
Sponsor
Geisinger Clinic
Collaborators
American Academy of Sleep Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05618444
Brief Title
Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA
Official Title
Enhancing Positive Positive Airway Pressure (PAP) Adherence Among Spanish-Speaking Hispanic Adults With Obstructive Sleep Apnea (OSA)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
May 30, 2026 (Anticipated)
Study Completion Date
May 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic
Collaborators
American Academy of Sleep Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
positive airway pressure (PAP), adherence, Hispanic, tele-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Automated Management (AM)
Arm Type
Experimental
Arm Description
Receipt of text-based behavioral intervention
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Control group receiving usual care for obstructive sleep apnea
Intervention Type
Behavioral
Intervention Name(s)
Automated Management (AM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
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
Title
Acceptability
Description
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
Title
Appropriateness
Description
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 Outcome Measure Information:
Title
Recruitment Rate
Description
Recruitment Rate computed at the end of the trial
Time Frame
6 months
Title
Retention Rate
Description
Retention Rate computed at the end of the trial
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Positive airway pressure (PAP) use from 3-6 months
Description
Hours of PAP use per 24 hours
Time Frame
3-6 months
Title
PAP adherence based on modified Centers for Medicare & Medicaid Services (CMS) criteria
Description
Adherence yes/no using ≥4 hours/night and ≥70% of nights
Time Frame
6 months
Title
Patient Satisfaction
Description
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
1 month
Title
Patient Satisfaction
Description
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
3 months
Title
Acceptability
Description
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
1 month
Title
Acceptability
Description
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
3 months
Title
Appropriateness
Description
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
1 month
Title
Appropriateness
Description
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
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Saconi, PhD
Phone
5702148191
Email
bsaconi@geisinger.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Saconi, PhD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanent Southern California
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis X Hwang, MD
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Ramirez, LCSW
First Name & Middle Initial & Last Name & Degree
Perales Puchalt Jaime, PhD
Facility Name
Geisinger
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17821
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Saconi, PhD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy M Sawyer, PhD
First Name & Middle Initial & Last Name & Degree
A J Watach, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

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