STITCH (Simplified Therapeutic Intervention To Control Hypertension)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Primary Treatment Algorithm Using Fixed Dose Combination Therapy for the Management of Hypertension - Control and Intervention Arms

Conditions
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Hypertension

Intervention / Treatment
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* Drug: fixed dose combination therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fixed dose combination therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, family physicians, fixed dose combination therapy, cluster randomized controlled trial