NCT00374270

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

December 11, 2007

Status Verified

December 1, 2007

First QC Date

September 8, 2006

Last Update Submit

December 7, 2007

Conditions

HypertensionDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Keywords

Diabetes (type I and type II)

Outcome Measures

Primary Outcomes (1)

  • difference in change in systolic BP between the intervention and usual care groups

    6 months

Secondary Outcomes (3)

  • change in antihypertensive therapy by new/additional hypertension medication or dosage increase between groups

    6 months

  • proportion of patients achieving goal BP of <130/80 mm Hg between groups

    6 months

  • proportion of patients that are prescribed an ACE inhibitor or angiotensin receptor antagonist between groups

    6 months

Interventions

Lifestyle Counselling; Opinion Leader Influence StatementsBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

Related Publications (1)

  • 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. doi: 10.1001/archinte.168.21.2355.

    PMID: 19029501DERIVED

Related Links

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ross T Tsuyuki, PharmD, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

May 1, 2005

Study Completion

May 1, 2007

Last Updated

December 11, 2007

Record last verified: 2007-12

Locations

CA(1)