NCT00201188

Brief Summary

The purpose of this study is to improve anti-inflammatory medication adherence and asthma outcomes by using reports of peak flow monitoring to prompt communication between patients and their doctors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Dec 2003

Longer than P75 for not_applicable 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

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

4.2 years

First QC Date

September 16, 2005

Last Update Submit

March 7, 2013

Conditions

AsthmaLung Diseases

Outcome Measures

Primary Outcomes (1)

  • Adherence to ICS medication

    Measured on a monthly basis

Study Arms (2)

1

EXPERIMENTAL

Participants will receive feedback and peak flow monitoring reports from their doctors.

Behavioral: Status Reports

2

NO INTERVENTION

Participants will receive usual care.

Interventions

Status ReportsBEHAVIORAL

Interpreted Analysis of Peak-Flow Monitoring Trends

1

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asthma
  • Currently using ICS
  • Planning to live in the San Francisco Bay Area in the year following study entry

You may not qualify if:

  • Diagnosis of any lung disease other than asthma
  • Has a smoking history greater than or equal to 15 pack-years
  • Psychological problems that may make monthly study visits impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco, Parnassus Campus

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • Janson SL, McGrath KW, Covington JK, Baron RB, Lazarus SC. Objective airway monitoring improves asthma control in the cold and flu season: a cluster randomized trial. Chest. 2010 Nov;138(5):1148-55. doi: 10.1378/chest.09-2394. Epub 2010 Jun 10.

    PMID: 20538819DERIVED

MeSH Terms

Conditions

AsthmaLung Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • Susan L. Janson, DNSc,ANP,RN

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

December 1, 2003

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations

US(1)