Weekly Phone Calls Versus Brief Patient Education to Improve Continuous Positive Airway Pressure (CPAP) Compliance

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

Weekly Phone Calls vs. Brief Patient Education to Improve CPAP Compliance: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945776
• Other study ID #: 08-04-2047
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2009
• Last updated: July 23, 2009
• Start date: April 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of three interventions on CPAP adherence.

Description:

To determine whether there is a need for a more intensive one on one interaction with the patient in order to improve CPAP usage. And also to try to identify in general which population of patients may require a more intensive intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All new patients undergoing of the Sleep Center suspected of having sleep apnea and undergoing sleep studies

Exclusion Criteria:

• Refusal to participate, or not suspected of having sleep apnea prior to the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea (OSA)
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Weekly phone calls
Calling weekly to answer questions regarding CPAP usage.
• Frequently asked questions
Answers to frequently asked questions in pre-printed form.
• Usual care
Answers will be provided by the renter of the equipment, and the sleep center if asked in addition to explanations by the sleep specialist.

Locations

Country	Name	City	State
United States	CAMC Sleep Center	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine which intervention will improve CPAP compliance in sleep apnea		6 weeks	No
Secondary	To try to identify which individual characteristics within a group may require a specific intervention		6 weeks	No