NCT00232557

Brief Summary

This project is investigating whether application of a telecommunications system to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak-flow-based action plans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_3 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

August 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

February 13, 2014

Completed
Last Updated

April 24, 2015

Status Verified

October 1, 2013

Enrollment Period

4.9 years

First QC Date

September 30, 2005

Results QC Date

November 27, 2013

Last Update Submit

April 6, 2015

Conditions

Keywords

AsthmaDisease ManagementTelecommunicationsHealth ServicesQuality of LifePatient Compliance

Outcome Measures

Primary Outcomes (1)

  • Participants With Unscheduled Asthma-related Visits

    Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.

    1 year

Secondary Outcomes (1)

  • Participants With Oral Corticosteroid Use

    1 year

Study Arms (2)

TLC-Asthma

EXPERIMENTAL

Telephone-based home education and asthma monitoring

Device: TLC-Asthma

TLC-health education

ACTIVE COMPARATOR

Telephone-based home education

Device: TLC-health education

Interventions

Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens

TLC-Asthma

A telephone-linked communication system (TLC) to provide general health education.

TLC-health education

Eligibility Criteria

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

You may qualify if:

  • Physician diagnosis of asthma
  • Receiving treatment with one or more daily controller (i.e., preventive) medications
  • Age = 18 years
  • Less than 30 pack years of cigarette smoking
  • FEVi greater than 50% of predicted
  • FEVi bronchodilator response of at least 12%
  • Ability to use a telephone without assistance

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

AsthmaPatient Compliance

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. David Sparrow
Organization
VA Boston Healthcare System

Study Officials

  • David William Sparrow, DSc

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

August 1, 2004

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

April 24, 2015

Results First Posted

February 13, 2014

Record last verified: 2013-10

Locations