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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01327456 |
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Date of registration:
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29/03/2011 |
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Primary sponsor: |
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Public title:
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The Effects of a Self-management Intervention on Low Literacy Patients With Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title:
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A Randomized Controlled Trial of a Literacy-sensitive Self-management Intervention for Chronic Obstructive Pulmonary Disease Patients |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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99 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01327456 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Daniel Jonas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina |
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Name:
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Darren Dewalt, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina |
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Name:
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Katie Kiser, Pharm.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- are age 18 years or older and,
- have been diagnosed with COPD
- are active patients in the General Internal Medicine or Pulmonary Clinics at the
Ambulatory Care Center
- are being treated with inhaled medication for their COPD
Exclusion Criteria:
- non-English speaking (intervention will be available in English only)
- participants unable to complete the study (either with or without assistance)
- patients who are currently experiencing an exacerbation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease
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Intervention(s)
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Behavioral: Self-Management Intervention
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Primary Outcome(s)
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change in Inhaler use technique scores from baseline to follow-up
[Time Frame: baseline and at 2-4 weeks later]
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Secondary Outcome(s)
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change in COPD-related knowledge from baseline to follow-up
[Time Frame: baseline and 2-4 week follow-up]
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change in smoking status from baseline to follow-up
[Time Frame: baseline and 2-4 week follow-up]
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time spent in self-management activities
[Time Frame: 2-4 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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