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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Apnea Syndromes
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 20, 2014