Detecting and Treating High Blood Pressure in Aboriginal Population and Low and Middle Income Countries

Hypertension Clinical Trial

— DREAM-GLOBAL  

Official title:

DREAM-GLOBAL: Diagnosing hypeRtension - Engaging Action and Management in Getting LOwer Bp in Aboriginal and LMIC - A Research Proposal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02111226
• Other study ID #: 182-2013
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2014
• Last updated: July 13, 2017
• Start date: January 2012
• Est. completion date: March 2018

Study information

• Verified date: July 2017
• Source: Sunnybrook Health Sciences Centre
• Contact: Diane Hua, MPH
• Phone: 416-480-6100
• Email: diane.hua[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Heart disease and stroke are the number one killers world-wide. When someone has hypertension, the constantly elevated blood pressure damages their blood vessels and the organs that they supply blood to. This causes stroke, heart attack, heart failure, kidney failure and dementia. Finding and lowering high blood pressure to normal with lifestyle changes and if necessary medications, lowers the risk of these outcomes. Canada has high rates of blood pressure control compared to other countries in the world, due in large part to the successful dissemination of hypertension guidelines. However remote and disadvantaged communities have not been as successful and need additional measures to help achieve the same level of blood pressure control as the rest of the country. The DREAM-GLOBAL team has extensive experience working with Canada's Aboriginal Communities and a large community in Tanzania. The DREAM-GLOBAL project will integrate innovations in technology with the implementation of guidelines-based blood pressure control and through partnerships with experts in government and industry, overcome barriers to lowering blood pressure in Canada's Aboriginal Communities, and in a community in Tanzania. Tools will be developed and tested that will close the circle of care around people with hypertension by bringing measurement data to the medical record and health care provider and also sending useful medical feedback to the person with hypertension via secure data servers and routine SMS messaging on cell phones. The system will be tested for effectiveness of diagnosing and also for managing hypertension. To begin the process of preventing hypertension, the team will also explore with an Aboriginal community how to create policies to reduce the sodium content in their food. If proven effective, DREAM-GLOBAL can also become a platform for managing other chronic diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Hypertension

• BP > 140/90 mmHg or > 130/80 mmHg if patient has diabetes at the initial screening visit using an approved automated BP monitor.

• If on drug therapy, continuous drug therapy with the same dosing interval for 8 weeks prior to and throughout the screening period. May be drug naive.

• Written informed consent

• Hypertension for at least 12 weeks before screening and throughout the screening period (according to the patient or their medical practitioner)

• Must have a cell phone plan (in Canada) and be willing to maintain the plan during the study. For Tanzania, must have a cell phone under a locally available Tanzanian carrier.

• Must be willing to take occasional local calls from study team members

• One or more of BMI > 30 kg/m2, diabetes, smoking, over age 40, previous history of CAD including stroke and heart attack

• An identified health care provider in the community (ie. Family Physician/Nurse Practitioner in Canada or Community Nurse/Clinical officer in Tanzania)

Exclusion Criteria:

• Change in antihypertensive medication during the 8 weeks before enrolment

• No cell phone plan compatible with the study.

• Poorly controlled hypertension with BP > 180/110 mmHg

• No primary health care provider

• Active malignant disease (except non-melanoma skin cancer)

• Unable or unwilling to visit health care provider

• Unable to read the SMS messages (English in Canada and Kiswahili in Tanzania)

• Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit.

• Planned elective surgery during the study period except for cataract surgery

• *For BP screening study, must not be on an antihypertensive in the last 6 months.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Hypertension

Intervention

Other:
• SMS text messaging
short message service

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	The change in blood pressure (systolic and diastolic) from baseline to the final BP measurement period	one year
Secondary	Blood Pressure	The proportion of patients achieving BP control during the study period.	one year