Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

Not Applicable

Completed

• Conditions: Hypertension; Diabetes Mellitus
• Interventions: Other: Nurse administered treatment algorithm

• Registration Number: NCT00741702
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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

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.

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Nurse administered treatment algorithm	A home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy.

Primary Outcome Measures

Name	Time	Method
systolic blood pressure	12 months

Secondary Outcome Measures

Name	Time	Method
Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events	12 months