The Effects of a Self-management Intervention on Low Literacy Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.
Chronic Obstructive Pulmonary Disease
Behavioral: Self-Management Intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of a Literacy-sensitive Self-management Intervention for Chronic Obstructive Pulmonary Disease Patients|
- change in Inhaler use technique scores from baseline to follow-up [ Time Frame: baseline and at 2-4 weeks later ] [ Designated as safety issue: No ]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 spent in self-management activities [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]participants will complete a time diary of all COPD related activities
- change in COPD-related knowledge from baseline to follow-up [ Time Frame: baseline and 2-4 week follow-up ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 2-4 week follow-up ] [ Designated as safety issue: No ]assessment of smoking status
|Study Start Date:||January 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Self-Management Intervention
participants who receive the one-on-one self-management intervention
Behavioral: Self-Management Intervention
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.
No Intervention: Usual Care
group receives no additional education or intervention then they would as usual care of their COPD
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327456
|United States, North Carolina|
|University of North Carolina Hospitals Ambulatory Care Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Daniel Jonas, MD||University of North Carolina|
|Principal Investigator:||Katie Kiser, Pharm.D.||University of North Carolina|
|Principal Investigator:||Darren Dewalt, MD||University of North Carolina|