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Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Primary Purpose

Sleep Apnea Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
i-PAP
Usual Care (Standard Care)
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Chronic Obstructive Sleep Apnea, Sleep Apnea, Sleep Apnea Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 18 years
  • confirmed diagnosis of OSA
  • being newly prescribed CPAP therapy
  • having chronic symptoms as noted on screening symptom checklist
  • fluency in English

Exclusion Criteria:

  • cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30)
  • residence in a geographical area outside of San Diego County
  • fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
  • significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment

Sites / Locations

  • Veterans Medical Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Usual Care (Standard Care)

Outcomes

Primary Outcome Measures

CPAP Adherence

Secondary Outcome Measures

Quality of patient-centered collaborative care

Full Information

First Posted
April 16, 2008
Last Updated
May 12, 2016
Sponsor
Veterans Medical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00662623
Brief Title
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
Official Title
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Medical Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.
Detailed Description
Poor treatment adherence with CPAP therapy is well-documented. Set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial-Usual Care patients (control) versus i-PAP patients (intervention). An important empirical-methodological advantage of the project is the objective measurement of CPAP adherence, which is measured by internal microprocessor as the "amount of time CPAP is used at the prescribed pressure." This objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-PAP intervention was designed around this central feature.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
Chronic Obstructive Sleep Apnea, Sleep Apnea, Sleep Apnea Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual Care (Standard Care)
Intervention Type
Behavioral
Intervention Name(s)
i-PAP
Intervention Description
Internet Intervention based on wireless telemonitoring of CPAP data and patient-centered, collaborative care
Intervention Type
Behavioral
Intervention Name(s)
Usual Care (Standard Care)
Intervention Description
Pre-determined clinic visits and telephone support
Primary Outcome Measure Information:
Title
CPAP Adherence
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Quality of patient-centered collaborative care
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 18 years confirmed diagnosis of OSA being newly prescribed CPAP therapy having chronic symptoms as noted on screening symptom checklist fluency in English Exclusion Criteria: cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30) residence in a geographical area outside of San Diego County fatal comorbidity (life expectancy less than 6 months as indicated by treating physician) significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl J. Stepnowsky, PhD
Organizational Affiliation
Veterans Medical Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Medical Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

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Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

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