Clinical trial NCT01327456: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: health literacy
self-management
inhaler technique
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2011-04-01
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: change in Inhaler use technique scores from baseline to follow-up
timeFrame: baseline and at 2-4 weeks later
Secondary outcomes:
measure: time spent in self-management activities
timeFrame: 2-4 weeks
measure: change in COPD-related knowledge from baseline to follow-up
timeFrame: baseline and 2-4 week follow-up
measure: change in smoking status from baseline to follow-up
timeFrame: baseline and 2-4 week follow-up
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals Ambulatory Care Center
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Daniel Jonas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Katie Kiser, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Darren Dewalt, MD
role: PRINCIPAL_INVESTIGATOR
References: