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
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: fixed dose combination therapy||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||2081 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Primary Treatment Algorithm Using Fixed Dose Combination Therapy for the Management of Hypertension - Control and Intervention Arms|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||January 2007|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129909
|Robarts Research Institute|
|London, Ontario, Canada, N6A 5K8|
|Study Director:||Ross D Feldman, MD||University of Western Ontario, Canada|