Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

Study Overview
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Brief Summary
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This randomized controlled trial was designed to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes.

Detailed Description
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Two community-based strategies for controlling hypertension in First Nations people with existing hypertension and diabetes were compared. In the intervention group, a home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. In the control group, treatment decisions were made by each subject's primary care physician. The primary outcome measure was the difference between the 2 groups in teh change in systolic blood pressure after 12 months.

Official Title
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Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

Conditions
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Hypertension, Diabetes Mellitus

Intervention / Treatment
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* Other: Nurse administered treatment algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>= 18 yr Type 2 diabetes mellitus Persistent hypertension (systolic pressure >= 130 mmHg, diastolic pressure >= 80 mm Hg, or both) Exclusion Criteria: use of beta blocker women of child-bearing age not able to use a reliable method of birth control Connective tissue disorder Severe systemic or malignant disease Inability to follow the protocol Bilateral renal artery stenosis and other causes of secondary hypertension Serum creatinine level > 250 micromol/L cerebrovascular even within 6 mo valvular heart disease unstable angina Myocardial infarction Revascularization procedure within 3 mo before study recruitment heart failure cardiac arrhythmia requiring medical treatment or heart block active hepatic disease

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>A home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. | Other: Nurse administered treatment algorithm<br>* Start with Irbesartan 150 mg/d; check BP in 6 wks, if BP >=130/80 mm HF, 300 mg/d irbesartan; check BP at next visit, if BP>= 130/80 mm Hg, add HCTZ 12.5 mg/d; check BP at next visit, if BP>=130/80 mm Hg, add verapamil 180 mg/d; check BP at next visit, if BP>=13/80 mm Hg, increase verapamil to 240 mg/d<br>|
| No Intervention: Control group<br>Treatment decisions were made by each subject's primary care physician. Participants in this group received usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Type 2 diabetes, First Nations populations