Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples (DREAM3)

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Hypertension; Diabetes Mellitus

Treatments: Other: Nurse administered treatment algorithm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00741702

231-2001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Intervention group

Experimental group

Description:

A home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy.

Treatment:

Other: Nurse administered treatment algorithm

Control group

No Intervention group

Description:

Treatment decisions were made by each subject's primary care physician. Participants in this group received usual care.