Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized Controlled Trial of a Literacy-sensitive Self-management Intervention for Chronic Obstructive Pulmonary Disease Patients
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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