Weekly Phone Calls Versus Brief Patient Education to Improve Continuous Positive Airway Pressure (CPAP) Compliance
This study has been completed.
Sponsor:
CAMC Health System
Information provided by:
CAMC Health System
ClinicalTrials.gov Identifier:
NCT00945776
First received: July 23, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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Purpose
The purpose of this study is to compare the effects of three interventions on CPAP adherence.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea (OSA) |
Behavioral: Weekly phone calls Behavioral: Frequently asked questions Behavioral: Usual care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Weekly Phone Calls vs. Brief Patient Education to Improve CPAP Compliance: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by CAMC Health System:
Primary Outcome Measures:
- To determine which intervention will improve CPAP compliance in sleep apnea [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To try to identify which individual characteristics within a group may require a specific intervention [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 128 |
| Study Start Date: | April 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Weekly phone calls
Will be called weekly to answer questions regarding usage.
|
Behavioral: Weekly phone calls
Calling weekly to answer questions regarding CPAP usage.
|
|
Active Comparator: Frequently asked questions
Providing written general answers to commonly asked questions.
|
Behavioral: Frequently asked questions
Answers to frequently asked questions in pre-printed form.
|
| Active Comparator: Usual care |
Behavioral: 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945776
Locations
| United States, West Virginia | |
| CAMC Sleep Center | |
| Charleston, West Virginia, United States, 25301 | |
Sponsors and Collaborators
CAMC Health System
Investigators
| Principal Investigator: | George L Zaldivar, M.D. | CAMC Health System |
More Information
No publications provided
| Responsible Party: | George L. Zaldivar, M.D., CAMC |
| ClinicalTrials.gov Identifier: | NCT00945776 History of Changes |
| Other Study ID Numbers: | 08-04-2047 |
| Study First Received: | July 23, 2009 |
| Last Updated: | July 23, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by CAMC Health System:
|
OSA CPAP |
Additional relevant MeSH terms:
|
Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013