Using Telemedicine to Improve Veteran Sleep Apnea Care
Primary Purpose
Sleep Apnea Syndromes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Video Teleconferencing Care
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Sleep Apnea Syndromes focused on measuring Telemedicine, continuous positive airway pressure, treatment adherence
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Moderate to Severe Sleep Apnea
- Live in San Diego County
- Veteran
Exclusion Criteria:
- Previous use of positive pressure airway therapy
- Residence outside of San Diego county
Sites / Locations
- VA San Diego Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Video Teleconferencing Care
Usual Care
Arm Description
Video teleconferencing care
Usual Care
Outcomes
Primary Outcome Measures
Treatment Adherence
Nightly CPAP adherence measured over the two-month period .
Secondary Outcome Measures
Full Information
NCT ID
NCT01259440
First Posted
December 10, 2010
Last Updated
October 5, 2015
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01259440
Brief Title
Using Telemedicine to Improve Veteran Sleep Apnea Care
Official Title
Using Telemedicine to Improve Veteran Sleep Apnea Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider.
Detailed Description
Background:
Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider
Objectives:
The objective of this proposal is to explore the feasibility and initially evaluate the potential efficacy of a video teleconferencing system for patients with Obstructive Sleep Apnea syndrome (OSA) that facilitates patient- centered, collaborative management for patients who are prescribed the gold-standard treatment, continuous positive airway pressure (CPAP).
Methods:
The evaluative aspect of this proposal was designed as a pilot randomized, controlled clinical trial of Video Teleconferencing (VTC) compared to Usual Care (UC). The key feature of the Video Teleconferencing intervention was the use of a telemedicine system that allows for audio/visual conferencing with the patient in their home environment from the start of treatment initialization. The provider is able provide more direct feedback to the patient based on the telemedicine interaction, and the patient benefits from increased contact with the provider. Specific inclusion and exclusion criteria included: age > 18 years; confirmed diagnosis of moderate-severe OSA; being newly prescribed CPAP therapy; having chronic symptoms as noted on screening symptom checklist; and fluency in English. Patients were recruited from the VA San Diego Healthcare System Pulmonary Sleep Clinic. Patients were enrolled for a 2-month time period. Groups were compared on quantitative and qualitative measures.
Status:
Study Complete
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
Telemedicine, continuous positive airway pressure, treatment adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video Teleconferencing Care
Arm Type
Active Comparator
Arm Description
Video teleconferencing care
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Video Teleconferencing Care
Intervention Description
The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Consists of one week telephone call and one month clinic visit
Primary Outcome Measure Information:
Title
Treatment Adherence
Description
Nightly CPAP adherence measured over the two-month period .
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Moderate to Severe Sleep Apnea
Live in San Diego County
Veteran
Exclusion Criteria:
Previous use of positive pressure airway therapy
Residence outside of San Diego county
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl J Stepnowsky, PhD
Organizational Affiliation
San Diego Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Using Telemedicine to Improve Veteran Sleep Apnea Care
We'll reach out to this number within 24 hrs