Clinical trial NCT01259440: Using Telemedicine to Improve Veteran Sleep Apnea Care
Official title: Using Telemedicine to Improve Veteran Sleep Apnea Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sleep Apnea Syndromes
Keywords: Telemedicine
continuous positive airway pressure
treatment adherence
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-12-14
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Treatment Adherence
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: San Diego Veterans Healthcare System
name: Carl J Stepnowsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: