Improving the Frequency and Quality of Sleep Apnea Care Management

NCT ID: NCT01916655

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-03
• Study Completion Date: 2018-03-30

Brief 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

standard and typical PAP (Positive Airway Pressure) educational and support protocol

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

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.

Self-Management Care

Individualized self-management educational and support protocol

Group Type: EXPERIMENTAL

Self-Management Care

Intervention Type: BEHAVIORAL

Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy

Usual Care

Intervention Type: BEHAVIORAL

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.

Self-Management Mobile Care

Individualized self-management educational and support protocol delivered in part by mobile health tool

Group Type: EXPERIMENTAL

Self-Management Mobile Care

Intervention Type: BEHAVIORAL

Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone

Usual Care

Intervention Type: BEHAVIORAL

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.

Interventions

Self-Management Care

Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy

Intervention Type: BEHAVIORAL

Self-Management Mobile Care

Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone

Intervention Type: BEHAVIORAL

Usual Care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age > 18 years;
• confirmed diagnosis of OSA;
• being newly prescribed CPAP therapy; and

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl J Stepnowsky, PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

IIR 12-069

Identifier Type: -

Identifier Source: org_study_id