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

NCT ID: NCT01327456

Last Updated: 2011-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-Management Intervention

participants who receive the one-on-one self-management intervention

Group Type: EXPERIMENTAL

Self-Management Intervention

Intervention Type: BEHAVIORAL

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.

Usual Care

group receives no additional education or intervention then they would as usual care of their COPD

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

University of North Carolina Department of Medicine

Principal Investigators

Daniel Jonas, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Katie Kiser, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Darren Dewalt, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina Hospitals Ambulatory Care Center

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

07-1771

Identifier Type: -

Identifier Source: org_study_id