The Effects of a Self-management Intervention on Low Literacy Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Management Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring health literacy, self-management, inhaler technique
Eligibility Criteria
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
Sites / Locations
- University of North Carolina Hospitals Ambulatory Care Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Self-Management Intervention
Usual Care
Arm Description
participants who receive the one-on-one self-management intervention
group receives no additional education or intervention then they would as usual care of their COPD
Outcomes
Primary Outcome Measures
change in Inhaler use technique scores from baseline to follow-up
The inhaler technique assessment will be conducted by using a pre-established protocol developed to cover the major types of inhalers used by the COPD population. General principles included in the assessment include correct preparation, administration, and if appropriate re-administration of a dose. The assessment will be scored as number of steps completed correctly out of total number of steps assessed.
Secondary Outcome Measures
time spent in self-management activities
participants will complete a time diary of all COPD related activities
change in COPD-related knowledge from baseline to follow-up
The baseline questionnaire will include measures of COPD-related knowledge, self-management techniques, quality of care, access to care, quality of life, costs, healthcare utilization, exacerbations, and basic demographic information.
change in smoking status from baseline to follow-up
assessment of smoking status
Full Information
NCT ID
NCT01327456
First Posted
March 29, 2011
Last Updated
March 31, 2011
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT01327456
Brief Title
The Effects of a Self-management Intervention on Low Literacy Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Randomized Controlled Trial of a Literacy-sensitive Self-management Intervention for Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose: To determine the role health literacy plays in the care continuum for Chronic Obstructive Pulmonary Disease (COPD) and the effect of a self-management intervention on inhaler technique use, time spent on self-management, and knowledge for COPD patients with low literacy.
Participants: The investigators will recruit patients from the University of North Carolina at Chapel Hill Ambulatory Care Center (ACC) who have a diagnosis of COPD.
Procedures (methods): Potential subjects with COPD will be identified through pharmacy claims data, clinic billing data and the electronic medical record. Eligibility will be prescreened by a research assistant (RA) using the electronic medical record prior to approaching potential subjects for consent. For the first part of the study, consenting subjects will complete a baseline health literacy assessment, a questionnaire, an inhaler technique assessment, and a diary of time spent in self-management activities. Pulmonary function tests (PFT) will be performed on all participants for whom PFTs have not been conducted within the previous 12 months. The questionnaire will include measures of COPD-related knowledge, self-management techniques, quality of care, access, quality of life, costs, healthcare utilization, exacerbations, and basic demographic information. The inhaler technique assessment will be administered by the research assistant using a pre-established protocol. The research assistant will abstract additional data from the medical record to assess the quality of care based on adherence to recommended COPD care guidelines. For the second part of the study, participants will be randomized to control and intervention arms. The self-management intervention will be an interactive experience, delivered by a trained research assistant, targeting self-management skills (inhaler use, using an action plan, etc), smoking cessation, and exercise/pulmonary rehabilitation. Those randomized to the control group will receive usual care. All participants will return 2-4 weeks after the intervention for a follow-up assessment of inhaler technique, COPD-related knowledge, and time spent in self-management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
health literacy, self-management, inhaler technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Management Intervention
Arm Type
Experimental
Arm Description
participants who receive the one-on-one self-management intervention
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
group receives no additional education or intervention then they would as usual care of their COPD
Intervention Type
Behavioral
Intervention Name(s)
Self-Management Intervention
Intervention Description
patients will participate in a 1-on-1 interactive intervention, delivered by a trained research assistant targeting self-management skills (e.g. inhaler use, use of an action plan), smoking cessation, and exercise/pulmonary rehabilitation. All participants will return 2-4 weeks after the intervention for a follow-up assessment of inhaler technique use, COPD-related knowledge, and time spent in self-management.
Primary Outcome Measure Information:
Title
change in Inhaler use technique scores from baseline to follow-up
Description
The inhaler technique assessment will be conducted by using a pre-established protocol developed to cover the major types of inhalers used by the COPD population. General principles included in the assessment include correct preparation, administration, and if appropriate re-administration of a dose. The assessment will be scored as number of steps completed correctly out of total number of steps assessed.
Time Frame
baseline and at 2-4 weeks later
Secondary Outcome Measure Information:
Title
time spent in self-management activities
Description
participants will complete a time diary of all COPD related activities
Time Frame
2-4 weeks
Title
change in COPD-related knowledge from baseline to follow-up
Description
The baseline questionnaire will include measures of COPD-related knowledge, self-management techniques, quality of care, access to care, quality of life, costs, healthcare utilization, exacerbations, and basic demographic information.
Time Frame
baseline and 2-4 week follow-up
Title
change in smoking status from baseline to follow-up
Description
assessment of smoking status
Time Frame
baseline and 2-4 week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Jonas, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katie Kiser, Pharm.D.
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darren Dewalt, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Hospitals Ambulatory Care Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of a Self-management Intervention on Low Literacy Patients With Chronic Obstructive Pulmonary Disease (COPD)
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