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NCT01327456 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
99
Enrollment target

NCT01327456: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT01327456 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 99 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01327456, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
99 participants
Enrollment target

Study 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

Primary Outcome

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.

Interventions

  • BEHAVIORAL Self-Management Intervention

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2008-01
Est. Completion 2008-12
Phase NA

What the finished NCT01327456 record still lists

NCT01327456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Self-Management Intervention is the first listed.

NCT01327456 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01327456 about?

NCT01327456 is a clinical study titled "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 ...

What is the current status of trial NCT01327456?

This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2008-01. Estimated completion is 2008-12.

What interventions are being tested in trial NCT01327456?

The interventions under investigation include: Self-Management Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT01327456?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01327456's enrollment target sits among peer trials

99 920th of 2000 higher than 1,079 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01327456, the US trial registry maintained by the National Library of Medicine. NCT01327456 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.