Weekly Phone Calls Versus Brief Patient Education to Impr... | NCT00945776

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

NCT00945776

Sponsor

CAMC Health System

Status

Completed

Last Update Posted

Jul 24, 2009Estimated

Enrollment

128Actual

Phase

Phase 2

Conditions

Obstructive Sleep Apnea (OSA)

Interventions

Weekly phone calls
Frequently asked questions
Usual care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Jul 23, 2009

First Submission Date that Met QC Criteria

Jul 23, 2009

First Posted Date

Jul 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2009

Last Update Posted Date

Jul 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Weekly phone calls	Active Comparator	Will be called weekly to answer questions regarding usage.	Behavioral: Weekly phone calls
Frequently asked questions	Active Comparator	Providing written general answers to commonly asked questions.	Behavioral: Frequently asked questions
Usual care	Active Comparator		Behavioral: Usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Weekly phone calls	Behavioral	Calling weekly to answer questions regarding CPAP usage.	Weekly phone calls

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George L Zaldivar, M.D.	CAMC Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CAMC Sleep Center		Charleston	West Virginia	25301	United States

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided