Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129909
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2005-08-10
Brief Title:
STITCH Simplified Therapeutic Intervention To Control Hypertension
Sponsor:
University of Western Ontario Canada
Organization:
University of Western Ontario Canada
Study Overview
Official Title:
Evaluation of a Primary Treatment Algorithm Using Fixed Dose Combination Therapy for the Management of Hypertension - Control and Intervention Arms
Status:
COMPLETED
Status Verified Date:
2012-06
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:
The objective of this study is to assess whether the implementation of a primary treatment algorithm using a fixed dose combination therapy will improve the management of hypertension when compared to usual management
Detailed Description:
There is a clear need for improved approaches for both improved blood pressure control and improved compliance with medication regimens Although decreasing the frequency of drug taking does improve blood pressure control whether fixed-dose combinations are more effective than taking multiple tablets is unknown Additionally notwithstanding the presence of excellent evidence-based recommendations for the treatment of hypertension the choices for practitioners in regards to first line therapy is widening and may be more confusing especially in the setting of the proliferation of recommendations for a range of diseases Whether a simplified treatment algorithm consistent with the Canadian Hypertension Education Program CHEP guidelines but using a step-care approach might improve management of hypertension is unknown The current study will determine the effectiveness of a simplified treatment algorithm which incorporates early use of a fixed-dose combination therapy
This is a cluster randomized controlled trial Approximately 50 family practices eligible for study participation will be randomized in a 11 ratio to implement a treatment algorithm or to continue usual care for the management of hypertension The randomization schedule will be stratified by the year of graduation of the family physician 1984 or 1984 Within each practice 50 subjects will be managed according to the algorithm or usual care and will be followed for six months
This is a cluster randomized controlled trial Approximately 50 family practices eligible for study participation will be randomized in a 11 ratio to implement a treatment algorithm or to continue usual care for the management of hypertension The randomization schedule will be stratified by the year of graduation of the family physician 1984 or 1984 Within each practice 50 subjects will be managed according to the algorithm or usual care and will be followed for six months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None