Improving the Quality of Asthma Care Using the Internet

This study has been completed.
Sponsor:
Collaborators:
Penn State University
Information provided by (Responsible Party):
Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00921401
First received: June 15, 2009
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

It is important for people with asthma to become involved in their asthma care and management. This study will evaluate an interactive Web site that provides tailored feedback and information to asthma patients and encourages them to ask their doctor specific questions about their asthma care.


Condition Intervention Phase
Asthma
Behavioral: Asthma Feedback
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Improving the Quality of Asthma Care Using the Internet

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Asthma control - as measured by the Asthma Control Test [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medication adherence, as measured by claims data [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Outpatient provider visits, as measured by claims data [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Asthma-related emergency department visits, as measured by claims data [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Enrollment: 408
Study Start Date: August 2009
Study Completion Date: February 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asthma Feedback
Each month and before all visits with their asthma care provider, participants will be encouraged to go online and answer a series of questions regarding the types of asthma medications they use and how often they use them, asthma symptoms they have experienced, emergency department visits in the past year, the care they have received for their asthma (e.g., specialist visits) in the past year, and the planned date of their next visit with their asthma care provider. Participants will receive tailored feedback about what questions they should ask their doctor during a subsequent visit, whether or not they should schedule a visit sooner, and links to read more about each recommendation.
Behavioral: Asthma Feedback
All participants will log in to the study Web site at least once a month and before all doctor visits. They will answer a series of questions and receive individualized feedback about the types of questions they should ask their doctor.
Active Comparator: Preventive Feedback
Each month and before all visits with their primary care provider, participants will be encouraged to go online and answer a series of questions regarding their preventive care. They will receive tailored feedback regarding preventive services, such as pap testing, cancer screenings, and flu shots. Participants will receive tailored feedback regarding preventive services (e.g., cancer screening) that they should discuss with their primary care provider.
Behavioral: Asthma Feedback
All participants will log in to the study Web site at least once a month and before all doctor visits. They will answer a series of questions and receive individualized feedback about the types of questions they should ask their doctor.

Detailed Description:

Asthma is a common cause of illness and lost productivity, including missed days of work and school, in the United States. It is important for people with asthma to become involved in their treatment and care. Previous studies have shown that encouraging people to ask their doctor for various medical tests and treatments improves preventive care (e.g., cancer screenings), but more research is needed on the effect this can have on asthma management. This study will involve an interactive Web site that will ask patients questions about their asthma symptoms and medications and provide suggestions and feedback on the types of questions patients may want to ask their doctors. By asking questions about their asthma care and increasing communication with their doctor, patients may experience improved quality of asthma care and better asthma control. The purpose of this study is to evaluate the impact of the interactive Web site on asthma control and other measures of asthma management.

This 12-month study will enroll people with asthma. Participants will be randomly assigned to either the Asthma Feedback group or the Preventive Feedback (control) group. Both groups will log in to the study Web site at least once a month for 12 months and before all doctor visits. After logging in to the Web site, participants in the Asthma Feedback group will answer a series of questions about their asthma care. They will then receive information and feedback on the types of questions they should ask their asthma care provider during their next office visit. Participants in the Preventive Feedback group will answer questions and receive information and feedback regarding preventive services (e.g., cancer screening, cholesterol screening) that they should discuss with their primary care provider. At baseline and Months 6 and 12, all participants will complete online questionnaires regarding their asthma and overall health. Study researchers will review participants' medical records and insurance claims data at the end of the study.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Only individuals with persistent asthma will be considered for this study. These definitions are made based on definitions from the National Committee for Quality Assurance (NCQA) and include individuals who meet either criteria A or B:

  • A: (Four or more prescription medications used for asthma treatment in 1 year) OR (One or more visits to the emergency room with a principal diagnosis of asthma in 1 year) OR (One or more inpatient hospital visits with a principal diagnosis of asthma in 1 year)
  • B: (Four or more outpatient visits with any diagnosis of asthma) AND (two or more claims for a prescription drug used for asthma treatment in 1 year)

Other Inclusion Criteria:

  • Speaks and reads English fluently
  • Member of Highmark
  • Has access to the Internet at home or at work
  • Has a valid e-mail address
  • No history of more than 20 pack-years of cigarette smoking
  • Enrolled in a Highmark health plan offering that includes prescription drug coverage

Exclusion Criteria:

  • Does not speak English
  • Does not have Internet access at home or work
  • Smoked more than 20 pack-years (to exclude possible chronic obstructive pulmonary disease [COPD])
  • Does not currently have asthma
  • Pregnant
  • Unwilling to consent
  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: NCT00921401

Locations
United States, Pennsylvania
Penn State Hershey Medical Center, Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Penn State University
Investigators
Principal Investigator: Christopher N Sciamanna, MD, MPH Penn State University
  More Information

No publications provided

Responsible Party: Christopher Sciamanna, MD, MPH, Professor of Medicine and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00921401     History of Changes
Other Study ID Numbers: 662, 5R01HL088590-02
Study First Received: June 15, 2009
Last Updated: May 6, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014