Improving the Frequency and Quality of Sleep Apnea Care Management

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01916655
First received: July 19, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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 our Self-Management intervention and improve the frequency and quality of patient-provider communications is a central component of that discovery process.


Condition Intervention
Obstructive Sleep Apnea
Behavioral: Self-Management Care
Behavioral: Self-Management Mobile Care
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Improving the Frequency and Quality of Sleep Apnea Care Management

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Positive Airway Pressure Adherence [ Time Frame: 2 month time point ] [ Designated as safety issue: No ]
    objective measurement of the amount of time PAP therapy is used at the prescribed pressure


Estimated Enrollment: 360
Study Start Date: July 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Usual Care
standard and typical PAP educational and support protocol
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.
Experimental: Self-Management Care
Individualized self-management educational and support protocol
Behavioral: Self-Management Care
Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy
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.
Experimental: Self-Management Mobile Care
Individualized self-management educational and support protocol delivered in part by mobile health tool
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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Our 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916655

Contacts
Contact: Tania Zamora, BA (858) 642-3269 tania.zamora@va.gov

Locations
United States, California
VA San Diego Healthcare System Not yet recruiting
San Diego, California, United States, 92161
Contact: Tania Zamora, BA    858-642-3269    tania.zamora@va.gov   
Principal Investigator: Carl J Stepnowsky, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Carl J Stepnowsky, PhD San Diego Veterans Healthcare System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01916655     History of Changes
Other Study ID Numbers: IIR 12-069
Study First Received: July 19, 2013
Last Updated: June 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Obstructive Sleep Apnea
Adherence
Chronic Disease
Telemedicine
Continuous Positive Airway Pressure
Mobile Health

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014