Assessing the Validity of the PAP Problems Triage Tool in Patients With PAP Treatment for Obstructive Sleep Apnea

NCT05530967 | Unknown

• 1 other identifier: KPSleep-006
• Study Type: interventional
• Target: 375
• Locations: 0 countries
• Sites: N/A

Brief Summary

The intended use of the Positive Airway Pressure (PAP) Problems Triaging Tool (TT) is to appropriately triage patients with a PAP-associated problem(s) to a specific intervention(s) based on patient responses. Thus, the proposed research will validate the tool, determine optimal scoring thresholds, and explore the utility of the tool as an indicator for intervention. Our central hypothesis is that the PAP Problems TT will identify treatment barriers that if unaddressed, are predictive of treatment non-adherence.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Positive Airway Pressure (PAP) Therapy; Triaging Tool; PAP Problems; PAP Adherence

Outcome Measures

Primary Outcomes (3)

• Factor Analysis

  Investigate the factor structure of the TT, an exploratory factor analysis (EFA) will be conducted. A forced six-factor EFA using a varimax rotation will be conducted to determine the factor loadings on six sub-scales and to determine whether the EFA factors are similar to the theoretically derived categories from the original TT instrument. Data from the TT collected at day 5 will be used for the factor analysis as we expect higher response rate at this first data collection endpo

  30 days

• Triaging Tool Validity

  Concurrent validity will assess the extent to which TT scores are related to concurrent PAP use. This will be established based on Pearson product moment correlation coefficients (for continuous PAP use \[hours/night\]) and Point Biserial correlations (for PAP non-adherence, defined as \<4 hours/night of use, on average) at three intervals: day 5 (PAP use on days 1-5), day 10 (PAP use on days 6-10), and day 30 (PAP use on days 11-30).

  30 days

• Triaging Tool Predictive Validity

  To determine the TT accuracy for predicting PAP non-adherence (defined as \<4 hours/night of use, on average) receiver operating characteristic (ROC) curves and respective area under the curve (AUC) with 95% confidence interval (CI) will be estimated using PAP TT subdomain scores as predictors for PAP non-adherence within 5 days post-TT score data collection. As TT data will be collected at 3 intervals (i.e., days 5, 10, and 30) and considering the 6 subdomains from the TT scale, a total of 18 ROCs/AUCs will be estimated.

  30 days

Secondary Outcomes (1)

• Changes in PAP Use Utilizing Video Education

  5 days

Study Arms (2)

Triaging Tool

EXPERIMENTAL

Other: TT

Video Education

EXPERIMENTAL

Other: TT; Other: VE

Interventions

TT OTHER

This intervention uses questionnaire at three-time intervals (i.e., days 5, 10, and 30) and abstraction of PAP use data (days 1 - 35). Consecutive adults with moderate-severe OSA and recommended to PAP treatment will be invited to the study. Once the patient has been prescribed PAP therapy a research associate will call the patient before receiving their new PAP device. The research associate will utilize an IRB approved telephone script to discuss study details, conduct eligibility screening (inclusion/exclusion criteria), and to ask whether the patient is interested in participating. The research associate will then send the patient an IRB approved digital information sheet. The information sheet will provide the patient an option to mark "Yes" if they are willing to participate in the study or "No" if they are not willing. Patients who indicate their willingness to participate will receive the Triage Tool in accordance with the study protocol.

Triaging Tool; Video Education

VE OTHER

A randomly selected sub-group of participants (n=30) will also receive an animated education video that provides targeted information and encouragement for self-managing your PAP problem(s). Patients in this sub-group will be asked to view a maximum of 2 different videos that are less than 2 minutes in duration. These videos are aligned with practice guideline recommendations for addressing PAP problems early in treatment. The videos will be sent digitally from Somnoware™.

Video Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kaiser Permanente Member (KP insured)
• OSA diagnosis by polysomnogram or Home Sleep Apnea Test with Apnea Hypopnea Index ≥ 15 events/hour
• PAP naïve
• Able to consent to participate
• Fluent or proficient with English
• Accepts PAP for home treatment

You may not qualify if:

• Chronic respiratory failure requiring Oxygen supplementation
• PAP device other than a PAP or AutoPAP (i.e., bilevel PAP)
• Pregnant

Sponsors & Collaborators

• Kaiser Permanente: lead

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

• Dennis Hwang, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Arguelles, BS

CONTACT

909-427-3032; jessica.arguelles@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: September 7, 2022
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share