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Trial record 1 of 1 for:    NCT00129909
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STITCH (Simplified Therapeutic Intervention To Control Hypertension)

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ClinicalTrials.gov Identifier: NCT00129909
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : June 14, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Western Ontario, Canada

Tracking Information
First Submitted Date  ICMJE August 10, 2005
First Posted Date  ICMJE August 12, 2005
Last Update Posted Date June 14, 2012
Study Start Date  ICMJE May 2005
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
The primary measure of outcome is the proportion of subjects treated to target (systolic blood pressure [SBP] <140 mmHg and diastolic blood pressure [DBP] <90 mmHg) at 6 months, compared at the practice level.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2005)
The primary measure of outcome is the proportion of subjects treated to target (SBP <140 mmHg and DBP <90 mmHg) at 6 months, compared at the practice level.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
  • Secondary measures of response will include the change at 6 months in systolic blood pressure and diastolic blood pressure. These outcomes will be compared at the practice level
  • Provider satisfaction will be obtained by means of a questionnaire administered at each practice after the last study participant completes the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2005)
  • Secondary measures of response will include the change at 6 months in systolic blood pressure and diastolic blood pressure. These outcomes will be compared at the practice level.
  • Provider satisfaction will be obtained by means of a questionnaire administered at each practice after the last study participant completes the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STITCH (Simplified Therapeutic Intervention To Control Hypertension)
Official Title  ICMJE Evaluation of a Primary Treatment Algorithm Using Fixed Dose Combination Therapy for the Management of Hypertension - Control and Intervention Arms
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 1:1 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: fixed dose combination therapy
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2007)
2081
Original Enrollment  ICMJE
 (submitted: August 10, 2005)
2500
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects 18 years or older
  • Hypertension SBP ≥ 140 mmHg or DBP ≥ 90 mmHg whether untreated or partially treated
  • Absence of ischemic heart disease, atrial fibrillation, peripheral vascular disease, stroke and chronic kidney disease
  • Not participating in other hypertension studies
  • Ability to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00129909
Other Study ID Numbers  ICMJE RPO402A; RPO402B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Western Ontario, Canada
Study Sponsor  ICMJE University of Western Ontario, Canada
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Ross D Feldman, MD University of Western Ontario, Canada
PRS Account University of Western Ontario, Canada
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP