Back to resultsWeekly Phone Calls Versus Brief Patient Education to Improve Continuous Positive Airway Pressure (CPAP) Compliance
Primary Purpose
Obstructive Sleep Apnea (OSA)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Weekly phone calls
Frequently asked questions
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea (OSA) focused on measuring OSA, CPAP
Eligibility Criteria
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
Sites / Locations
- CAMC Sleep Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Weekly phone calls
Frequently asked questions
Usual care
Arm Description
Will be called weekly to answer questions regarding usage.
Providing written general answers to commonly asked questions.
Outcomes
Primary Outcome Measures
To determine which intervention will improve CPAP compliance in sleep apnea
Secondary Outcome Measures
To try to identify which individual characteristics within a group may require a specific intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00945776
Brief Title
Weekly Phone Calls Versus Brief Patient Education to Improve Continuous Positive Airway Pressure (CPAP) Compliance
Official Title
Weekly Phone Calls vs. Brief Patient Education to Improve CPAP Compliance: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CAMC Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the effects of three interventions on CPAP adherence.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
Keywords
OSA, CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weekly phone calls
Arm Type
Active Comparator
Arm Description
Will be called weekly to answer questions regarding usage.
Arm Title
Frequently asked questions
Arm Type
Active Comparator
Arm Description
Providing written general answers to commonly asked questions.
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Weekly phone calls
Intervention Description
Calling weekly to answer questions regarding CPAP usage.
Intervention Type
Behavioral
Intervention Name(s)
Frequently asked questions
Intervention Description
Answers to frequently asked questions in pre-printed form.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Answers will be provided by the renter of the equipment, and the sleep center if asked in addition to explanations by the sleep specialist.
Primary Outcome Measure Information:
Title
To determine which intervention will improve CPAP compliance in sleep apnea
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
To try to identify which individual characteristics within a group may require a specific intervention
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George L Zaldivar, M.D.
Organizational Affiliation
CAMC Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAMC Sleep Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
12. IPD Sharing Statement
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Weekly Phone Calls Versus Brief Patient Education to Improve Continuous Positive Airway Pressure (CPAP) Compliance
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