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

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01327456
First received: March 29, 2011
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Behavioral: Self-Management Intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 99
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327456

Locations
United States, North Carolina
University of North Carolina Hospitals Ambulatory Care Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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
  More Information

No publications provided

Responsible Party: Daniel Jonas, MD / Assistant Professor, University of North Carolina Department of Medicine
ClinicalTrials.gov Identifier: NCT01327456     History of Changes
Other Study ID Numbers: 07-1771
Study First Received: March 29, 2011
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
health literacy
self-management
inhaler technique

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014