Improving the Frequency and Quality of Sleep Apnea Care Management
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      OSA is a major chronic condition affecting the quality of life of millions of Americans. Per
      the Institute of Medicine new treatment adherence strategies are needed to help improve the
      quality of care, reduce social and economic costs, and help those with chronic conditions
      (such as OSA) live healthier and more productive lives through better management of their
      conditions. Using an mHealth tool to help deliver the investigators' Self-Management
      intervention and improve the frequency and quality of patient-provider communications is a
      central component of that discovery process.
    

Detailed description: 
      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.
    

Intervention name(s): Self-Management Care; Self-Management Mobile Care; Usual Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy; Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone; standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Adherence; Chronic Disease; Telemedicine; Continuous Positive Airway Pressure; Mobile Health