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Medication Adherence in COPD--A Self-Regulation Study

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00005717
Collaborator
(none)
59
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    Study Design

    Study Type:
    Observational
    Study Start Date :
    Aug 1, 1990
    Actual Study Completion Date :
    Jul 1, 1995

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 100 Years
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      No

      No eligibility criteria

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • National Heart, Lung, and Blood Institute (NHLBI)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00005717
      Other Study ID Numbers:
      • 4926
      • R01HL042489
      First Posted:
      May 26, 2000
      Last Update Posted:
      May 13, 2016
      Last Verified:
      Jun 1, 2001
      Additional relevant MeSH terms:
      Bronchitis
      Lung Diseases
      Lung Diseases, Obstructive
      Pulmonary Disease, Chronic Obstructive
      Emphysema

      Study Results

      No Results Posted as of May 13, 2016