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

May 15, 2012 updated by: Sheldon Tobe, Sunnybrook Health Sciences Centre
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
A home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy.
Other: Nurse administered treatment algorithm
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
No Intervention: Control group
Treatment decisions were made by each subject's primary care physician. Participants in this group received usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
systolic blood pressure
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Pfizer
Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Sheldon Tobe, MD, FRCPC, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

August 25, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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