DREAM-GLOBAL: Diagnosing hypeRtension - Engaging Action and Management in Getting LOwer Bp in Aboriginal and LMIC - A Research Proposal
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Passive SMS Group
Passive SMS messages focused on lifestyle adjustment
干预措施: SMS text messaging (Other)
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.
干预措施: SMS text messaging (Other)
结局指标
主要结局
Blood Pressure
时间窗: one year
The change in blood pressure (systolic and diastolic) from baseline to the final BP measurement period
次要结局
- Blood Pressure(one year)
研究者
Sheldon Tobe
Principal Investigator - Medical Doctor
Sunnybrook Health Sciences Centre