Improving the Frequency and Quality of Sleep Apnea Care Management

The objective of this proposal is to evaluate a new mobile health (mHealth) system for
patients with Obstructive Sleep Apnea syndrome (OSA) that facilitates patient-centered,
collaborative management for patients prescribed the first-line treatment, continuous
positive airway pressure (CPAP). CPAP adherence rates are disappointingly low. The mHealth
system proposed for use in the study is informed by the group's previous interventional
efforts, including that of an interactive website intervention for OSA patients prescribed
CPAP. Limitations of that intervention included use of an immobile desktop computer for
website access and that it was not based on a previously evaluated protocol. The advantages
to the proposed mHealth system are the use of a mobile device to allow for increased
patient-provider communications and the incorporation of the Sleep Apnea Self-Management
Program protocol. The evaluative aspect of this proposal is designed as a randomized,
controlled clinical trial-Usual Care (control; UC); Self-Management Care (intervention 1;
SM); Self-Management via mHealth (intervention 2; SM-Mobile). The key feature of the
SM-Mobile intervention is the use of a mHealth tool that allows for the provision of the
Self-Management Program through the utilization of audio/visual conferencing,
self-monitoring, and treatment tracking with the patient remotely (i.e., in the non-clinic
environment).

The overarching aim of the present project is to examine the effect of this patient-centered,
collaborative care intervention on improving the quality of care, and increasing CPAP
adherence to a clinically meaningful level. The central questions that encompass the
conceptual and empirical contours of the study: Does the SM-Mobile intervention have an
effect on the patient's experience of care, CPAP adherence, and OSA outcomes relative to
Usual Care and Self-Management Care? To answer these research questions, and in the process
address fundamental intervention efficacy and cost issues in telemedicine, the proposed
randomized, controlled trial aims specifically to achieve the following goals:

This project has the following specific aims:

Aim 1: To examine the effect of the Self-Management Care delivered by mHealth (SM-Mobile)
intervention compared to Usual Care (SM) and Self-Management Care (SM) on level of CPAP
adherence. The hypothesis is that participants in SM-Mobile group will exhibit higher levels
of CPAP adherence compared to the UC and SM groups over the 2-month intervention period.

Aim 2: To examine the effect of the SM-Mobile intervention, compared to Usual Care and
Self-Management Care, on the patient's experience of the quality of patient-centered,
collaborative care (as measured by the Patient Assessment of Chronic Illness Care and the
CAHPS Clinician & Group Survey). The hypothesis is that participants in the SM-Mobile group
will experience a greater improvement in patient-centered, collaborative care compared to the
UC and SM groups over the 2-month follow-up period.

Aim 3: To examine the effect of SM-Mobile, compared to UC and SM, on OSA apnea outcomes
(e.g., OSA symptoms and OSA-specific health-related quality of life [HRQOL]). The hypothesis
is that participants in the SM-Mobile group will experience greater improvements in
self-reported OSA symptoms and HRQOL from baseline compared to the UC and SM over the 2-month
follow-up period.

Aim 4: To perform a basic cost analysis of the SM-Mobile intervention compared to Usual Care,
applying a micro-cost methodology of measuring the quantity of inputs used in the production
of care and the unit cost of each. This will be a test against the null hypothesis of no
significant cost differences between groups.

Inclusion Criteria:

The project will have a 4-year timeline. Patients and providers at both the VA Pulmonary
Sleep Clinic will participate in this prospective randomized clinical trial. Patients will
participate by completing written informed consent, agreeing to be randomized, completing a
baseline assessment, participating in the study interventional protocol, and completing
follow-up assessments up to one-year post-intervention. The intent is to recruit a study
population that is fairly representative of the overall VASDHS population of patients
diagnosed with OSA. To this end, inclusion criteria are designed to be as inclusive as
possible and are operationalized as follows:

- age > 18 years;

- confirmed diagnosis of OSA;

- being newly prescribed CPAP therapy; and

- having chronic symptoms as noted on screening symptom checklist. OSA diagnosis by the
Sleep Clinic has been and is currently consistent with published consensus
statements49 that CPAP treatment is indicated when the apnea-hypopnea index (AHI,
number of apneas + hypopneas per hour of sleep) is either (1) greater than or equal to
15, or (2) between 5 and 15 AND accompanied by documented sleep apnea symptoms,
including excessive daytime sleepiness, impaired cognition, mood disorders, insomnia,
and documented cardiovascular diseases. Because mild OSA symptoms are at best modestly
correlated with AHI, the research study will focus on patients with moderate to severe
sleep apnea, and therefore inclusion criteria will require AHI > 15.

Exclusion Criteria:

- Exclusion criteria include cognitive impairment sufficient to cause inability to
complete the protocol (MMSE < 24/30);

- residence in a geographical area outside of San Diego County (which could make some
necessary face-to-face contact difficult);

- 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 (i.e., clinical needs of patient outweighs needs of research study). No
exclusion criteria or any other study design elements will be used directly or
indirectly to restrict study participation by women, members of minority groups, or
primary language. Because men have a greater risk for OSA (and are identified and
diagnosed at a greater rate) than women, we anticipate a final sample that reflects
the OSA base rate differences on sex. Some minority groups are thought to have higher
OSA prevalence rates than Caucasians, so assuming they are being screened/diagnosed at
the same rates as Caucasians, we expect minority groups to be included in the study at
levels that reflect those rates.