NCT00921401

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 7, 2013

Status Verified

May 1, 2013

Enrollment Period

2.3 years

First QC Date

June 15, 2009

Last Update Submit

May 6, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Asthma control - as measured by the Asthma Control Test

    Measured at Year 1

Secondary Outcomes (3)

  • Medication adherence, as measured by claims data

    Measured at Year 1

  • Outpatient provider visits, as measured by claims data

    Measured at Year 1

  • Asthma-related emergency department visits, as measured by claims data

    Measured at Year 1

Study Arms (2)

Asthma Feedback

EXPERIMENTAL

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

Preventive Feedback

ACTIVE COMPARATOR

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

Interventions

Asthma FeedbackBEHAVIORAL

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.

Asthma FeedbackPreventive Feedback

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center, Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Pool AC, Kraschnewski JL, Poger JM, Smyth J, Stuckey HL, Craig TJ, Lehman EB, Yang C, Sciamanna CN. Impact of online patient reminders to improve asthma care: A randomized controlled trial. PLoS One. 2017 Feb 3;12(2):e0170447. doi: 10.1371/journal.pone.0170447. eCollection 2017.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Christopher N Sciamanna, MD, MPH

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Public Health Sciences

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2011

Study Completion

February 1, 2013

Last Updated

May 7, 2013

Record last verified: 2013-05

Locations