Improving Blood Pressure Management in Patients With Diabetes (SCRIP-HTN)

This study has been completed.
Sponsor:
Collaborators:
Canadian Diabetes Association
Heart and Stroke Foundation of Canada
College and Association of Registered Nurses of Alberta
Alberta Health & Wellness
Medicine Shoppe of Canada
Canadian Council of Cardiovascular Nurses
MED Institute, Incorporated
Capital Health, Canada
Alberta Heritage Foundation for Medical Research
Alberta Medical Association
Merck Frosst Canada Ltd.
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00374270
First received: September 8, 2006
Last updated: December 7, 2007
Last verified: December 2007
  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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • difference in change in systolic BP between the intervention and usual care groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374270

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8
Sponsors and Collaborators
University of Alberta
Canadian Diabetes Association
Heart and Stroke Foundation of Canada
College and Association of Registered Nurses of Alberta
Alberta Health & Wellness
Medicine Shoppe of Canada
Canadian Council of Cardiovascular Nurses
MED Institute, Incorporated
Capital Health, Canada
Alberta Heritage Foundation for Medical Research
Alberta Medical Association
Merck Frosst Canada Ltd.
Investigators
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:
Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014