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Medication Adherence in COPD--A Self-Regulation Study

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005717
  Purpose

To test the effectiveness of a self-management program for chronic obstructive disease (COPD) patients. The program to improve adherence could be conducted by nurses or other clinic staff in settings where comprehensive rehabilitation services were not available.


Condition
Lung Diseases, Obstructive
Bronchitis
Emphysema
Chronic Obstructive Pulmonary Disease

MedlinePlus related topics:   Bronchitis    COPD (Chronic Obstructive Pulmonary Disease)    Emphysema   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:   August 1990
Estimated Study Completion Date:   July 1995

Detailed Description:

BACKGROUND:

In 1990, the available data on medication adherence among chronic obstructive pulmonary disease (COPD) patients consistently indicated that adherence was a significant problem. This was a particularly distressing finding, considering that pharmacological therapy was considered the backbone of COPD management in settings where comprehensive rehabilitation services were limited. Despite the importance of this issue and a large data base on how to enhance medication adherence among medical populations, there had been no empirical investigations evaluating the implementation of these strategies with COPD patients.

DESIGN NARRATIVE:

The prospective, controlled study randomized 230 emphysema and chronic bronchitis patients from an urban university medical center into either a "usual care", control group or into a self-management skills training program for improving adherence. The training program was based on self-management procedures for enhancing adherence which had proven efficacious with diverse populations.

Self-reported and objective measures of adherence were examined during the two month baseline period and the one year follow-up in the controlled study. A range of possible covariates including demographics, patient characteristics, treatment, and therapeutic outcome variables were also collected during the baseline phase and at the 6-month and 12-month follow-up visits in the controlled study to evaluate their relationship to the observed adherence levels.

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

No eligibility criteria

  Contacts and Locations

No Contacts or Locations Provided
  More Information


Study ID Numbers:   4926
First Received:   May 25, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00005717
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Pathologic Processes
Bronchial Diseases

ClinicalTrials.gov processed this record on December 03, 2008




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