HypertensionDREAM-GLOBALNCT02111226
Detecting and Treating High Blood Pressure in Aboriginal Population and Low and Middle Income Countries
A study testing SMS text messaging in people with Hypertension and Cardiovascular Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension, Cardiovascular Disease, Diabetes
- What is being tested?
- SMS text messaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Nancy Perkins, 416-480-6100 ext. 7064, dream.global@sunnybrook.ca
Sheldon W Tobe, MD
About this study
Official title: DREAM-GLOBAL: Diagnosing hypeRtension - Engaging Action and Management in Getting LOwer Bp in Aboriginal and LMIC - A Research Proposal
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
- Being tested
- SMS text messaging
- Keywords
- hypertension, cardiovascular disease, diabetes, chronic disease management
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS text messagingOther
short message service
| Study group | Role | What they receive |
|---|---|---|
| Passive SMS Group | Active comparator | Passive SMS messages focused on lifestyle adjustment Receives: 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. Receives: Other: SMS text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
The change in blood pressure (systolic and diastolic) from baseline to the final BP measurement period
Measured: one year
Secondary outcomes (1)
Blood Pressure
The proportion of patients achieving BP control during the study period.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Sheldon Tobe, Sunnybrook Health Sciences Centre
- Investigators
- Sheldon W Tobe, MD, MScCH (HPTE), FRCPC, FACP,, Principal investigator, Sunnybrook Health Sciences Centre, University of TorontoKaren E Yeates, MD, FRCP(C), MPH, Principal investigator, Queen's UniversityNorman RC Campbell, MD, FRCPC, Principal investigator, University of CalgaryPeter Liu, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111226
- Sponsor's protocol ID
- 182-2013
- Acronym
- DREAM-GLOBAL
- Status last verified
- Jul 2017
- First submitted
- 13 Mar 2014
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31815678Maar 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.
PubMed 31682574Tobe 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.
PubMed 30474909Yeates 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.
PubMed 29258978Maar 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.
PubMed 28428165
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DREAM-GLOBAL: Diagnosing hypeRtension - Engaging Action and Management in Getting LOwer Bp in Aboriginal and LMIC - A Research Proposal
- ClinicalTrials.gov ID
- NCT02111226
- Acronym / sponsor ID
- DREAM-GLOBAL / 182-2013
- Conditions
- Hypertension, Cardiovascular Disease, Diabetes
- Keywords
- hypertension, cardiovascular disease, diabetes, chronic disease management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2012
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive SMS Group | Active comparator | Other: SMS text messagingPassive SMS messages focused on lifestyle adjustment |
| Active SMS Group | Experimental | Other: SMS text messagingActive 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS text messagingshort message service | Other | Active SMS Group, Passive SMS Group |
Primary outcome
Blood Pressure
Time frame: one year
The change in blood pressure (systolic and diastolic) from baseline to the final BP measurement period
1 secondary outcome
Blood Pressure
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Derived from this study: PubMed 31815678Barsky 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.
- Derived from this study: PubMed 31682574Maar 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.
- Derived from this study: PubMed 30474909Tobe 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.
- Derived from this study: PubMed 29258978Yeates 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.
- Derived from this study: PubMed 28428165Maar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon W Tobe, MD, MScCH (HPTE), FRCPC, FACP, principal investigator
Sunnybrook Health Sciences Centre, University of Toronto
Karen E Yeates, MD, FRCP(C), MPH principal investigator
Queen's University
Norman RC Campbell, MD, FRCPC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS text messaging in people with Hypertension and Cardiovascular Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diane Hua, MPH (416-480-6100 ext. 2186, diane.hua@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02111226, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.