NCT00233233

Brief Summary

This study will examine how the assessment mode influences the validity of self-reported adherence to asthma therapy. Self-reported adherence to asthma therapy data will be collected using one of three randomized assessment modes (interview, computer, or telephone).

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

Timeline
Completed

Started Aug 2002

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

October 3, 2005

Last Update Submit

December 11, 2017

Conditions

Lung DiseasesAsthma

Outcome Measures

Primary Outcomes (1)

  • Concordance between patient's self-reported medication adherence and electronically measured adherence

    Measured at Months 1 through 5

Secondary Outcomes (2)

  • Impact of mode of assessment on adult self-reports of asthma symptoms, asthma management practices, and quality of life

    Measured at Months 1 through 5

  • Relationship between baseline measures of psychosocial variables (i.e., personality and mood) and the primary outcome

    Measured at Months 1 through 5

Interventions

Standardized Asthma Education ProgramBEHAVIORAL

Eligibility Criteria

Age19 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of asthma
  • Under a provider's care for asthma
  • Prescribed daily inhaled corticosteroids (by metered dose inhaler \[MDI\]) at least 2 times a day
  • Speaks English
  • Otherwise in good general health

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Lung DiseasesAsthma

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Cynthia Rand, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 5, 2005

Study Start

August 1, 2002

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

US(1)