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

July 23, 2009 updated by: CAMC Health System

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • CAMC Sleep Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine which intervention will improve CPAP compliance in sleep apnea
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To try to identify which individual characteristics within a group may require a specific intervention
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CAMC Health System

Investigators

  • Principal Investigator: George L Zaldivar, M.D., CAMC Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (ESTIMATE)

July 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 24, 2009

Last Update Submitted That Met QC Criteria

July 23, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-04-2047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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