Improving the Quality of Asthma Care Using the Internet

Asthma Clinical Trial

Official title:

Improving the Quality of Asthma Care Using the Internet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921401
• Other study ID #: 662
• Secondary ID: 5R01HL088590-02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 15, 2009
• Last updated: May 6, 2013
• Start date: August 2009
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: February 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center, Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Heart, Lung, and Blood Institute (NHLBI), Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control - as measured by the Asthma Control Test		Measured at Year 1	No
Secondary	Medication adherence, as measured by claims data		Measured at Year 1	No
Secondary	Outpatient provider visits, as measured by claims data		Measured at Year 1	No
Secondary	Asthma-related emergency department visits, as measured by claims data		Measured at Year 1	No