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

NCT02111226 | Unknown DMC

• 1 other identifier: 182-2013
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cardiovascular Disease; Diabetes

Keywords

hypertension; cardiovascular disease; diabetes; chronic disease management

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

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

  one year

Secondary Outcomes (1)

• Blood Pressure

  one year

Study Arms (2)

Passive SMS Group

ACTIVE COMPARATOR

Passive SMS messages focused on lifestyle adjustment

Other: SMS text messaging

Active SMS Group

EXPERIMENTAL

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

Interventions

SMS text messaging OTHER

short message service

Active SMS Group; Passive SMS Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

Related Publications (5)

• 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.

  PMID: 31815678 DERIVED

• 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.

  PMID: 31682574 DERIVED

• 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.

  PMID: 30474909 DERIVED

• 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.

  PMID: 29258978 DERIVED

• 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.

  PMID: 28428165 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Hua, MPH

CONTACT

416-480-6100; diane.hua@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Medical Doctor

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: April 11, 2014
• Study Start: January 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 17, 2017

Record last verified: 2017-07

Locations

CA (1)