search
Back to results

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

Primary Purpose

Hypertension, Cardiovascular Disease, Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SMS text messaging
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, cardiovascular disease, diabetes, chronic disease management

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Passive SMS Group

Active SMS Group

Arm Description

Passive SMS messages focused on lifestyle adjustment

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2014
Last Updated
July 13, 2017
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
search

1. Study Identification

Unique Protocol Identification Number
NCT02111226
Brief Title
Detecting and Treating High Blood Pressure in Aboriginal Population and Low and Middle Income Countries
Acronym
DREAM-GLOBAL
Official Title
DREAM-GLOBAL: Diagnosing hypeRtension - Engaging Action and Management in Getting LOwer Bp in Aboriginal and LMIC - A Research Proposal
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Disease, Diabetes
Keywords
hypertension, cardiovascular disease, diabetes, chronic disease management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Passive SMS Group
Arm Type
Active Comparator
Arm Description
Passive SMS messages focused on lifestyle adjustment
Arm Title
Active SMS Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SMS text messaging
Intervention Description
short message service
Primary Outcome Measure Information:
Title
Blood Pressure
Description
The change in blood pressure (systolic and diastolic) from baseline to the final BP measurement period
Time Frame
one year
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
The proportion of patients achieving BP control during the study period.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Hua, MPH
Phone
416-480-6100
Ext
2186
Email
diane.hua@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon W Tobe, MD, MScCH (HPTE), FRCPC, FACP,
Organizational Affiliation
Sunnybrook Health Sciences Centre, University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen E Yeates, MD, FRCP(C), MPH
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norman RC Campbell, MD, FRCPC
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Liu, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Perkins
Phone
416-480-6100
Ext
7064
Email
dream.global@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Sheldon W Tobe, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31815678
Citation
Barsky J, Hunter R, McAllister C, Yeates K, Campbell N, Liu P, Perkins N, Hua-Stewart D, Maar MA, Tobe SW. Analysis of the Implementation, User Perspectives, and Feedback From a Mobile Health Intervention for Individuals Living With Hypertension (DREAM-GLOBAL): Mixed Methods Study. JMIR Mhealth Uhealth. 2019 Dec 9;7(12):e12639. doi: 10.2196/12639.
Results Reference
derived
PubMed Identifier
31682574
Citation
Maar MA, Beaudin V, Yeates K, Boesch L, Liu P, Madjedi K, Perkins N, Hua-Stewart D, Beaudin F, Wabano MJ, Tobe SW. Wise Practices for Cultural Safety in Electronic Health Research and Clinical Trials With Indigenous People: Secondary Analysis of a Randomized Clinical Trial. J Med Internet Res. 2019 Nov 4;21(11):e14203. doi: 10.2196/14203.
Results Reference
derived
PubMed Identifier
30474909
Citation
Tobe SW, Yeates K, Campbell NRC, Maar MA, Perkins N, Liu PP, Sleeth J, McAllister C, Hua-Stewart D, Wells G, Bernick J. Diagnosing hypertension in Indigenous Canadians (DREAM-GLOBAL): A randomized controlled trial to compare the effectiveness of short message service messaging for management of hypertension: Main results. J Clin Hypertens (Greenwich). 2019 Jan;21(1):29-36. doi: 10.1111/jch.13434. Epub 2018 Nov 26.
Results Reference
derived
PubMed Identifier
29258978
Citation
Yeates K, Campbell N, Maar MA, Perkins N, Liu P, Sleeth J, Smith C, McAllister C, Hua-Stewart D, Wells G, Tobe SW. The Effectiveness of Text Messaging for Detection and Management of Hypertension in Indigenous People in Canada: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Dec 19;6(12):e244. doi: 10.2196/resprot.7139.
Results Reference
derived
PubMed Identifier
28428165
Citation
Maar MA, Yeates K, Perkins N, Boesch L, Hua-Stewart D, Liu P, Sleeth J, Tobe SW. A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings. JMIR Mhealth Uhealth. 2017 Apr 20;5(4):e47. doi: 10.2196/mhealth.7044.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs