Recruiting

Observational Study

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT02111226

Conditions

Hypertension

Cardiovascular Disease

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SMS text messaging

Study Details

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 ID

NCT02111226

Start date

Jan, 2012

Status verified date

Jul, 2017

Completion date

Mar, 2018

Anticipated

Primary completion date

Jan, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Passive SMS Group

Passive SMS messages focused on lifestyle adjustment

experimental: 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.

Interventions

SMS text messaging

short message service

Primary outcome measure

  • Blood Pressure [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Diane Hua, MPH

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Nancy Perkins

416-480-6100dream.global@sunnybrook.ca

Principal Investigator:

Sheldon W Tobe, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jul 17, 2017

Last verified

Jul, 2017

Keywords

  • hypertension
  • cardiovascular disease
  • diabetes
  • chronic disease management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2017-07-17.