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IIR 02-230 – HSR&D Study

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IIR 02-230
RCT of a Telecommunications System in Sleep Apnea
David William Sparrow DSc
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, MA
Funding Period: April 2004 - March 2008

BACKGROUND/RATIONALE:
Obstructive sleep apnea syndrome (OSAS) is an important chronic disease of adults, affecting an estimated 4% of men and 2% of women in the United States. Nasal continuous positive airway pressure (CPAP) has been demonstrated to ameliorate the symptoms and neurobehavioral consequences of OSAS. Unfortunately, patient adherence with prescribed CPAP is low, diminishing the benefits obtained from this expensive therapy. Nurse-administered patient education and monitoring of CPAP use through home visits has been shown to be effective in significantly improving CPAP adherence. Given the logistic complexity of delivering this service and its costs, it is unlikely to be disseminated widely into clinical practice. An alternative, using advanced telecommunications technology to deliver similar adherence improvement services, is proposed for study.

OBJECTIVE(S):
Use of Telephone-Linked Communication (TLC) systems with other important health-related behaviors such as medication-taking, diet, and exercise have demonstrated significant improvements in therapy adherence. We hypothesize that application of a TLC system to the care of adult patients with OSAS will enhance CPAP adherence.

METHODS:
This research project represents a randomized controlled trial of a TLC system designed to improve CPAP adherence (TLC-CPAP). The study enrolled adults with OSAS being started on nasal CPAP therapy. Subjects were randomized to TLC-CPAP or an attention placebo control group with a primary outcome of use of nasal CPAP therapy over a 12-month interval. Analyses were performed using an intent-to-treat approach.


FINDINGS/RESULTS:
We enrolled 250 adults with OSAS and an apnea-hypopnea index (AHI) > 10 who were randomized to either TLC-CPAP (n = 124) or an attention placebo control group (n = 126). Outcome assessments were performed at 6 and 12 months. The 250 subjects are 82% male and had the following mean (SD) baseline characteristics: age, 54.1 (12.2); BMI, 36.6 (7.9); AHI, 46.1 (29.9). Baseline characteristics of the intervention and control groups were comparable. There has been very little loss to follow-up, with 86% of subjects completing the 12-month follow-up.

During follow-up, the intervention and control groups were compared on the average hours per night of CPAP usage as measured by a covert adherence meter. The TLC-CPAP intervention group showed a higher nightly CPAP usage when compared to the controls (p = 0.031). We also examined the relationship between amount of CPAP use and disease-specific QOL and OSAS symptoms. The amount of CPAP use was predictive of improvements of QOL (Functional Outcomes of Sleep Questionnaire [FOSQ]), sleep symptoms, and depression (Center for Epidemiological Studies Depression [CES-D] scale). The amount of CPAP use did not influence daytime vigilance as assessed by reaction time measurements.

IMPACT:
This Telephone-Linked Communications (TLC) technology offers an effective, low-cost, and easy-to-use means of providing disease-specific education, monitoring, and counseling to improve adherence with therapy.

PUBLICATIONS:
None at this time.


DRA: Health Systems
DRE: Treatment - Observational
Keywords: Quality of life, Sleep disorders, Telemedicine
MeSH Terms: none

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