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

NCT ID: NCT02111226

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2018-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Passive SMS Group

Passive SMS messages focused on lifestyle adjustment

Group Type: ACTIVE_COMPARATOR

SMS text messaging

Intervention Type: OTHER

short message service

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.

Group Type: EXPERIMENTAL

SMS text messaging

Intervention Type: OTHER

short message service

Interventions

SMS text messaging

short message service

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Sheldon Tobe

Principal Investigator - Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheldon W Tobe, MD, MScCH (HPTE), FRCPC, FACP,

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre, University of Toronto

Karen E Yeates, MD, FRCP(C), MPH

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Norman RC Campbell, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Peter Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Diane Hua, MPH

Role: CONTACT

diane.hua@sunnybrook.ca

416-480-6100 ext. 2186

Facility Contacts

Nancy Perkins

Role: primary

dream.global@sunnybrook.ca

416-480-6100 ext. 7064

References

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.

Reference Type: DERIVED

PMID: 31815678 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31682574 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30474909 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29258978 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28428165 (View on PubMed)

Other Identifiers

182-2013

Identifier Type: -

Identifier Source: org_study_id