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

Sunnybrook Health Sciences Centre

Status: Unknown

Conditions: Hypertension; Diabetes; Cardiovascular Disease

Treatments: Other: SMS text messaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02111226

182-2013

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 2 patient groups

Passive SMS Group

Active Comparator group

Description:

Passive SMS messages focused on lifestyle adjustment

Treatment:

Other: SMS text messaging

Active SMS Group

Experimental group

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.

Treatment:

Other: SMS text messaging