The Effects of a Self-management Intervention on Low Literacy Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327456
• Other study ID #: 07-1771
• Status: Completed
• Phase: N/A
• First received: March 29, 2011
• Last updated: March 31, 2011
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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.

Locations

Country	Name	City	State
United States	University of North Carolina Hospitals Ambulatory Care Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and at 2-4 weeks later	No
Secondary	time spent in self-management activities	participants will complete a time diary of all COPD related activities	2-4 weeks	No
Secondary	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.	baseline and 2-4 week follow-up	No
Secondary	change in smoking status from baseline to follow-up	assessment of smoking status	baseline and 2-4 week follow-up	No