Diabetes Mellitus, Hypertension
Conditions
Keywords
Hypertension, Type 2 diabetes, First Nations populations
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.
Interventions
OTHERNurse 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
Sponsors
Canadian Institutes of Health Research (CIHR)
Pfizer
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| systolic blood pressure | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events | 12 months |
Outcome results
None listed