- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00941694
Asthma Self-Management in Older Adults
January 15, 2013 updated by: Alan Baptist, University of Michigan
Asthma self-management is an effective way to improve the outcomes of patients with asthma.
However, to be most effective these interventions should be targeted and designed toward a specific population or group.
There is currently no asthma self-management intervention directed towards older adults.
The hypothesis is that a 6-session asthma self-management intervention will improve the outcomes of older patients with asthma.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48105
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:: Age over 65, physician diagnosed asthma, need for daily asthma control medication, access to a telephone.
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Exclusion Criteria: Smoking history greater than 40 pack years, current smoker, mental impairment that would preclude participation in the asthma self management program
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Management Intervention
Will receive 6 asthma self-management group or individual session over a 7 week period
|
Intervention arm will receive 6 group or individual sessions over a 7 week period
|
|
Placebo Comparator: Control
Group will receive 3 phone calls not related to asthma self management over a 7 week period
|
3 phone calls not related to asthma self-management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Asthma Quality of Life Questionnaire
Time Frame: 3 months, 6 months, 1 year
|
3 months, 6 months, 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Asthma Control Questionnaire
Time Frame: 3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
|
Health Care Utilization
Time Frame: 3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan P Baptist, MD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
July 17, 2009
First Submitted That Met QC Criteria
July 17, 2009
First Posted (Estimate)
July 20, 2009
Study Record Updates
Last Update Posted (Estimate)
January 16, 2013
Last Update Submitted That Met QC Criteria
January 15, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N011060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.