NCT01454830

Tailored Intervention to Promote Positive Airway Pressure Adherence

Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the feasibility of a tailored (i.e., individualized) intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.

Detailed description

Poor adherence to CPAP is a significant problem among OSA patients resulting in suboptimal health and functional outcomes. Intervention studies to promote CPAP adherence have shown relatively small effects in selected samples and were costly. The overall objective of this research is to examine the effect, feasibility, and acceptability of a tailored intervention on CPAP adherence among adults with newly-diagnosed, CPAP treated OSA. The central hypothesis is that critically timed tailored interventions that focus on sociocultural aspects and cognitive perceptions of the individual experience with OSA diagnosis and treatment will improve overall CPAP adherence rates. The pilot randomized controlled trial will examine CPAP adherence outcomes at 1wk, 1mo, and 3mo among those randomly assigned to the tailored intervention or usual (standard) care and examine specific feasibility and participant acceptability outcomes in order to design and conduct a subsequent larger randomized controlled trial testing the overall efficacy of the tailored intervention.

Conditions

• Sleep Apnea, Obstructive
• Patient Compliance

Interventions

Type	Name	Description
BEHAVIORAL	Tailored	Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
OTHER	Usual care	Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-10-19
• Last updated: 2016-11-23
• Results posted: 2016-11-23

Locations

1 site across 1 country: United States