Medication Adherence in COPD--A Self-Regulation Study - Tabular View

Tracking Information
First Received Date ^ICMJE	May 25, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	August 1990
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00005717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Medication Adherence in COPD--A Self-Regulation Study
Official Title ^ICMJE
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.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Natural History, Longitudinal
Condition ^ICMJE	Lung Diseases, Obstructive Bronchitis Emphysema Chronic Obstructive Pulmonary Disease
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	July 1995
Primary Completion Date
Eligibility Criteria ^ICMJE	No eligibility criteria
Gender	Male
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00005717
Responsible Party
Study ID Numbers ^ICMJE	4926
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Heart, Lung, and Blood Institute (NHLBI)
Verification Date	June 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP