Improving Blood Pressure Management in Patients With Diabetes (SCRIP-HTN)
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Purpose
About 22% of Canadians have high blood pressure, or hypertension. However, studies have shown that only 1 out of 5 people with hypertension have their blood pressure controlled.
Diabetes is also an important risk factor for heart disease and stroke. About half of people with diabetes also have hypertension - a deadly combination. Studies have shown that only about 1 in 10 people with diabetes have their blood pressure controlled adequately - clearly something needs to be done to improve this.
Heart disease, stroke, hypertension, and diabetes are conditions that occur in the community, so we need to explore innovative solutions that will work in the community. Pharmacists are well-placed in the community to help identify people with diabetes and hypertension. This has worked very well in previous studies in patients with high cholesterol levels. Pharmacists and nurses have complementary skills which, when working as a team, may help identify and better manage hypertension in people with diabetes.
Our main objective is to test whether a community pharmacist and nurse team can improve blood pressure control in people with diabetes and hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 |
Behavioral: Lifestyle Counselling; Opinion Leader Influence Statements |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Improving Blood Pressure Management in Patients With Diabetes: SCRIP-HTN |
- difference in change in systolic BP between the intervention and usual care groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- change in antihypertensive therapy by new/additional hypertension medication or dosage increase between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- proportion of patients achieving goal BP of <130/80 mm Hg between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- proportion of patients that are prescribed an ACE inhibitor or angiotensin receptor antagonist between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 227 |
| Study Start Date: | May 2005 |
| Study Completion Date: | May 2007 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The following patients will be eligible for study participation:
- Patients with either type 1 or type 2 diabetes. Diabetes will be defined as those patients presently taking either oral hypoglycemic agents or insulin therapy (oral hypoglycemic agents to include all drugs in the drug classes of: alpha-glucosidase inhibitors, biguanides, meglitinides, sulfonylureas, thiazolidinediones and adjunctive therapy) taken for >6 months to rule-out steroid-induced diabetes and gestational diabetes.
Exclusion Criteria:
Patients will be excluded from the study if they:
- Do not provide or are unable to provide written informed consent
- Refuse or are unlikely to attend follow-up visits for BP measurements
- Are institutionalized
- Are <18 years of age
- Do not understand English
- Enrolled in other diabetes or hypertension trials
Subjects will be recruited whether or not they are receiving antihypertensive therapy.
Contacts and Locations| Canada, Alberta | |
| University of Alberta | |
| Edmonton, Alberta, Canada, T6G 2C8 | |
| Principal Investigator: | Ross T Tsuyuki, PharmD, MSc | University of Alberta |
More Information
Additional Information:
No publications provided by University of Alberta
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Ross Tsuyuki, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT00374270 History of Changes |
| Other Study ID Numbers: | EPICORE-GG5130000107 |
| Study First Received: | September 8, 2006 |
| Last Updated: | December 7, 2007 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Alberta:
|
Diabetes (type I and type II) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Hypertension Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013