Medication Adherence in COPD--A Self-Regulation Study
Primary Purpose
Lung Diseases, Obstructive, Bronchitis, Emphysema
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Lung Diseases, Obstructive
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005717
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005717
Brief Title
Medication Adherence in COPD--A Self-Regulation Study
Study Type
Observational
2. Study Status
Record Verification Date
June 2001
Overall Recruitment Status
Completed
Study Start Date
August 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1995 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Obstructive, Bronchitis, Emphysema, Chronic Obstructive Pulmonary Disease
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Learn more about this trial
Medication Adherence in COPD--A Self-Regulation Study
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