Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005717
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Medication Adherence in COPD--A Self-Regulation Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL042489 | NIH | None | httpsreporternihgovquickSearchR01HL042489 |