Improving Blood Pressure Management in Patients With Diabetes - Full Text View

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

This study has been completed.

First Received on September 8, 2006. Last Updated on December 7, 2007 History of Changes

Sponsor:	University of Alberta
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

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetes Type 2 High Blood Pressure

U.S. FDA Resources

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

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

McLean DL, McAlister FA, Johnson JA, King KM, Makowsky MJ, Jones CA, Tsuyuki RT; SCRIP-HTN Investigators. A randomized trial of the effect of community pharmacist and nurse care on improving blood pressure management in patients with diabetes mellitus: study of cardiovascular risk intervention by pharmacists-hypertension (SCRIP-HTN). Arch Intern Med. 2008 Nov 24;168(21):2355-61.

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 24, 2012