Improving Blood Pressure Management in Patients With Diabetes
NCT ID: NCT00374270
Last Updated: 2007-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
227 participants
INTERVENTIONAL
2005-05-31
2007-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objective: To determine the efficacy of a community-based multidisciplinary screening and intervention program on blood pressure control in patients with diabetes.
Design and Methods: Design: Subjects will be randomized to pharmacist/ANP intervention or usual care. Inclusion criteria: Adult patients with diabetes with a BP of \>130/80 mm Hg on 2 consecutive visits 2 weeks apart. Exclusion criteria: patients who are institutionalized or unlikely/unable to comply with follow up visits. Procedures: Patients will be recruited via: 1) community pharmacies (patients identified by diabetes drug prescriptions), and 2) referrals via Capital Health Regional Diabetes Intake Program. Patients will be invited by telephone to attend an in-pharmacy clinic. At Visit #1, the ANP will complete a history and physical exam (including a BP taken using the BPTru® device, 6 readings performed 1 minutes apart in the non-dominant arm, with last 5 readings averaged) (12). The pharmacist will review each patient's medication history. If the averaged readings are \>130/80 mm Hg, the patient will be invited to attend a 2nd clinic in 2 weeks. If the averaged BPs from both visits are \>130/80 mm Hg, the patient will be approached for consent to participate in the randomized trial. Intervention group receives: a BP wallet card with discussion as to the meaning of the BP measures, CVD risk reduction counseling, a hypertension education pamphlet, and referral to their primary care physician for further assessment/management. The BP results will then be faxed along with any recommendations to the patient's primary care physician. Written recommendations from local opinion leaders will be used to reinforce the latest hypertension guidelines. Follow-up: Patients will be followed up at 6 weeks to ensure they have made an appointment with their physician and to re-measure BP. BP will be measured at 6-week intervals (Week 6, 12, 18 with faxing of BP results and recommendations to the primary care physician), with a final follow-up visit at Week 24. Usual care group receives: BP wallet card with recorded BP measures, a pamphlet on diabetes, general diabetes advice given by ANP and usual care by their physician. Follow-up: No scheduled follow up visits. One phone call to patient will occur at 12 weeks to inquire about changes to BP management. A final follow-up visit will occur at week 24 to re-evaluate BP and to offer the patients the intervention program.
Evaluation: Outcome measures: The primary endpoint is the difference in change in systolic BP between intervention and usual care groups at 6 months. Secondary endpoints will include: (1) change in antihypertensive therapy (new medication or dosage increase), (2) % patients achieving BP target of \<130/80 mm Hg, and (3) % patients using ACE inhibitors or angiotensin receptor antagonists. Sample Size: A sample size of 85 patients per group will provide 90% power (assuming a standard deviation of 20mmHg and 2-sided alpha=0.05) to detect a 10mmHg difference in the primary endpoint. To account for drop-outs, we will increase this to 110 patients per group. Analysis: Demographic characteristics will be summarized using percentages for categorical variables and medians (interquartile range) for continuous variables. To compare the change in BP between intervention and usual care, we will use a 2-sample independent t-test. Significance of Study: Treatment and control of hypertension in people with diabetes is a major public health problem, and improving detection and control of hypertension is a major goal of the Canadian Hypertension Society. Novel ways of identification and treatment to guideline targets in this patient population are urgently needed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lifestyle Counselling; Opinion Leader Influence Statements
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Diabetes Association
OTHER
Heart and Stroke Foundation of Canada
OTHER
College and Association of Registered Nurses of Alberta
OTHER
Alberta Health & Wellness
OTHER_GOV
Medicine Shoppe of Canada
UNKNOWN
Canadian Council of Cardiovascular Nurses
OTHER
MED Institute, Incorporated
INDUSTRY
Capital Health, Canada
OTHER
Alberta Heritage Foundation for Medical Research
OTHER
Alberta Medical Association
OTHER
Merck Frosst Canada Ltd.
INDUSTRY
University of Alberta
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of Alberta
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ross T Tsuyuki, PharmD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alberta
Edmonton, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EPICORE-GG5130000107
Identifier Type: -
Identifier Source: org_study_id