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OpenTrials
Completed

NCT Number: NCT01327456

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Hospitals Ambulatory Care Center

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management Intervention

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.

Primary outcomes

  1. change in Inhaler use technique scores from baseline to follow-up

    Time frame: baseline and at 2-4 weeks later

    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 outcomes

  1. time spent in self-management activities

    Time frame: 2-4 weeks

    participants will complete a time diary of all COPD related activities

  2. change in COPD-related knowledge from baseline to follow-up

    Time frame: baseline and 2-4 week 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.

  3. change in smoking status from baseline to follow-up

    Time frame: baseline and 2-4 week follow-up

    assessment of smoking status

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

A Randomized Controlled Trial of a Literacy-sensitive Self-management Intervention for Chronic Obstructive Pulmonary Disease Patients

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 1, 2011
Registry last updated
Apr 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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