DREAM-GLOBAL: Detecting and Treating High Blood Pressure in Aboriginal Population and Low and Middle Income Countries

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT02111226
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
360
1
2
74
4.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: SMS text messaging
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
DREAM-GLOBAL: Diagnosing hypeRtension - Engaging Action and Management in Getting LOwer Bp in Aboriginal and LMIC - A Research Proposal
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Passive SMS Group

Passive SMS messages focused on lifestyle adjustment

Other: SMS text messaging
short message service

Experimental: Active SMS Group

Active SMS messages based on hypertension clinical practice guidelines including rational for taking antihypertensive medication and reminders to see the health care practioner if BP is above target.

Other: SMS text messaging
short message service

Outcome Measures

Primary Outcome Measures

  1. Blood Pressure [one year]

    The change in blood pressure (systolic and diastolic) from baseline to the final BP measurement period

Secondary Outcome Measures

  1. Blood Pressure [one year]

    The proportion of patients achieving BP control during the study period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre
  • Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Sheldon W Tobe, MD, MScCH (HPTE), FRCPC, FACP,, Sunnybrook Health Sciences Centre, University of Toronto
  • Principal Investigator: Karen E Yeates, MD, FRCP(C), MPH, Queen's University
  • Principal Investigator: Norman RC Campbell, MD, FRCPC, University of Calgary
  • Principal Investigator: Peter Liu, MD, Ottawa Heart Institute Research Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheldon Tobe, Principal Investigator - Medical Doctor, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02111226
Other Study ID Numbers:
  • 182-2013
First Posted:
Apr 11, 2014
Last Update Posted:
Jul 17, 2017
Last Verified:
Jul 1, 2017
Keywords provided by Sheldon Tobe, Principal Investigator - Medical Doctor, Sunnybrook Health Sciences Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2017