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IIR 07-163 – HSR Study

 
IIR 07-163
Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
Carl J Stepnowsky, Jr., PhD
VA San Diego Healthcare System, San Diego, CA
San Diego, CA
Funding Period: July 2008 - June 2012
BACKGROUND/RATIONALE:
A number of interventions to improve CPAP treatment adherence have been previously examined with mixed results and limitations including lack of guiding theoretical model. The current project was based on a patient-centered, collaborative care model, which focuses on providing the right treatment at the right time to chronic illness patients. The project compared an individualized Self-Management (SM) intervention, a Telemonitored Care (TC) intervention, and Combined Care (SM+TC) relative to a Usual Care control. Under Usual Care, there is a time lag, ranging in practice from days to weeks, between adherence data collection and data availability to care providers. Under Telemonitoring Care, adherence data are wirelessly transmitted to a remote server/database in 24-hour cycles, where they are then accessible to system-authorized care providers. Individualized Self-Management provides tailored education focused on increasing the knowledge and skills required by OSA patients to better use CPAP and manage their OSA.

OBJECTIVE(S):
The four primary aims of the research are (1) to compare the groups on level of CPAP adherence over the 3-month period of monitoring; (2) to compare the groups of proposed mediating variables from Social Cognitive Theory; (3) to compare the three groups on sleep apnea outcomes (e.g., severity of OSA symptoms and OSA-specific health-related quality of life); and (4) to analyze the costs of providing each intervention.

METHODS:
The study was designed as a randomized, controlled clinical trial of one control group (Usual Care) and three interventions-individualized Self-Management (SM); Telemonitored Care (TC); and Combined Care (Self-Management plus Telemonitored Care) (TC+SM). The Usual Care group was characterized by a one-week phone call and one-month clinic visit (at which time the CPAP data was downloaded and reviewed). The TC group was characterized by the provision of a wireless data modem that allowed for the transmission of CPAP data daily. The staff could review the data and proactively intervene when adherence or efficacy was out of range. Initial contact was by telephone, and clinic visits were scheduled as needed. The SM group was characterized by two clinic visits (at one week and at one month). The fourth group was a combination of TC and SM protocols. Assessments were made at baseline, post-intervention and 6-month follow-up.

FINDINGS/RESULTS:
Two hundred eighty patients diagnosed with OSA and prescribed CPAP therapy were studied with 73 in the UC group, 67 in the TC group, 65 in the SM group, and 75 in the TC+SM group. At baseline for the entire group the mean age = 68.7 160.5, mean apnea-hypopnea index (AHI) = 34.8 19.6, mean body mass index (BMI) =34.7 23.7, and mean Epworth Sleepiness Scale (ESS) = 11.5 5.4. There were no baseline differences in age, AHI, BMI, or ESS between the groups.

Nightly CPAP adherence measured over the three-month period was 3.2 2.3, 3.7 2.3, 3.7 1.8, and 3.7 2.2 hours per night (mean SD; p=0.50) for the UC, TC, SM, and TC+SM groups, respectively. The number and duration of clinical contacts were measured for each encounter. The groups differed on the total number of contacts (3.1 1.5, 4.2 2.7, 3.2 1.9, and 3.7 2.1 (mean SD; p=0.009) and on the total number of minutes of contact (78.4 40.9, 64.8 54.9, 127.7 42.5, and 130.3 54.6 minutes (p<0.0001) for the UC, TC, SM, and TC+SM groups, respectively. The groups did not differ on self-efficacy or outcome expectations, nor did they differ on measures of sleep apnea symptoms, sleepiness level or health-related quality of life.

Because our field is interested in identifying those interventions that are efficient (ie, produce good adherence levels per the staff time spent delivering those interventions), we took the opportunity to calculate a ratio of mean adherence (hours/night) per one hour of clinical contact. Given the shorter mean duration of contact for the TC and UC groups, the best ratio was for the TC group (5.9 hrs of CPAP use per night for each 1 hour contact time) and the second best ratio was for the UC group (3.6). It would appear that the extra time burden of the individualized SM (1.5) and SM+TC (1.4) groups did not result in good efficiency relative to the TC or UC groups (p<0.0001).

IMPACT:
Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help OSA patients live happier, healthier, and more productive lives through improved clinical management. The key finding of the present study was that while our interventional groups did not improve adherence over the usual care group, the Telemonitoring Care group was the most efficient of the tested groups, resulting in an adherence level of nearly 6 hours per night per 1 hour of clinical contact. In fact, TC protocol was uniquely designed to identify those patients with low adherence or poor efficacy and then to work to troubleshoot problems so that the problems are overcome. While the group self-management program that our team evaluated in a previous study did improve CPAP adherence, the current individualized SM program did not improve adherence relative to UC. This suggests that an important factor of the SM program is the group-based format. The group-based format from a time perspective also might have efficiencies from the perspective that one staff member could meet with up to 8 patients simultaneously (ie, 8 clinic visits x 1 hour = 8 hours; 8 group members x 1 hour = 1 hour clinical contact time). The advantage of telemonitoring technologies are that data from the CPAP is available to the treating sleep providers the very next day, which can inform the clinical management of the sleep apnea patient and promote collaborative care. Future research will need to examine the effect of stepped care protocols in an effort to deploy TC, but to then offer increasingly intensive interventions as needed. Given the increasingly large demand for CPAP follow-up while staffing levels are held contants, new innovative care methods are needed.


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PUBLICATIONS:

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DRA: Other Conditions, Substance Use Disorders, Health Systems
DRE: Treatment - Observational, Treatment - Comparative Effectiveness
Keywords: Adherence, Sleep disorders, Telemedicine
MeSH Terms: none

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