- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02111226
Detecting and Treating High Blood Pressure in Aboriginal Population and Low and Middle Income Countries (DREAM-GLOBAL)
13. juli 2017 oppdatert av: Sheldon Tobe, Sunnybrook Health Sciences Centre
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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
360
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Diane Hua, MPH
- Telefonnummer: 2186 416-480-6100
- E-post: diane.hua@sunnybrook.ca
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M4N3M5
- Rekruttering
- Sunnybrook Health Sciences Centre
-
Ta kontakt med:
- Nancy Perkins
- Telefonnummer: 7064 416-480-6100
- E-post: dream.global@sunnybrook.ca
-
Hovedetterforsker:
- Sheldon W Tobe, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Passive SMS Group
Passive SMS messages focused on lifestyle adjustment
|
short message service
|
Eksperimentell: 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.
|
short message service
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Blood Pressure
Tidsramme: one year
|
The change in blood pressure (systolic and diastolic) from baseline to the final BP measurement period
|
one year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Blood Pressure
Tidsramme: one year
|
The proportion of patients achieving BP control during the study period.
|
one year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sheldon W Tobe, MD, MScCH (HPTE), FRCPC, FACP,, Sunnybrook Health Sciences Centre, University of Toronto
- Hovedetterforsker: Karen E Yeates, MD, FRCP(C), MPH, Queen's University
- Hovedetterforsker: Norman RC Campbell, MD, FRCPC, University of Calgary
- Hovedetterforsker: Peter Liu, MD, Ottawa Heart Institute Research Corporation
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2012
Primær fullføring (Forventet)
1. januar 2018
Studiet fullført (Forventet)
1. mars 2018
Datoer for studieregistrering
Først innsendt
13. mars 2014
Først innsendt som oppfylte QC-kriteriene
8. april 2014
Først lagt ut (Anslag)
11. april 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juli 2017
Sist bekreftet
1. juli 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 182-2013
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Hypertensjon
-
University Hospital of CologneUkjentNAFLD; Hypertensjon, White-Coat Hypertension, Masked HypertensionTyskland
-
Karolinska InstitutetFullførtWhite Coat Hypertension
-
Clinical Hospital Centre ZagrebEuropean Society of HypertensionUkjentWhite Coat Hypertension | Blodtrykk | LivsstilsrisikoreduksjonIsrael, Hellas, Belgia, Tyskland, Armenia, Østerrike, Bulgaria, Kroatia, Tsjekkia, Estland, Italia, Libanon, Litauen, Nederland, Polen, Portugal, Romania, Serbia, Spania, Sverige, Ukraina, Storbritannia
-
Regional Hospital HolstebroFullførtSunn | White Coat Hypertension | Essensiell hypertensjonDanmark
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Aktiv, ikke rekrutterendeWhite Coat Hypertension | Hypertensjon, viktigForente stater
-
University of Alabama at BirminghamTroy UniversityFullførtHypertensjon | Hypertensjon, motstandsdyktig mot konvensjonell terapi | Ukontrollert hypertensjon | Hypertensjon, hvit pelsForente stater
-
PD Dr. Grégoire WuerznerSwiss National Science FoundationFullførtHypertensjon | Overvekt | White Coat Hypertension | Resistent hypertensjonSveits
-
University Hospital, ToursFullførtPTFE-dekkede stenter versus nakne stenter i TIPS (Transjugulær Intra-hepatisk Porto-systemisk shunt)Cirrhotic Portal HypertensionFrankrike
-
Sun Yat-sen UniversityFullførtHepatocellulært karsinom (HCC) | Cirrhotic Portal HypertensionKina
Kliniske studier på SMS text messaging
-
Aga Khan UniversityFullført
-
Johns Hopkins UniversityNational Institute of Nursing Research (NINR)FullførtBekkenbetennelsessykdom (PID)Forente stater
-
VA Office of Research and DevelopmentFullført
-
Columbia UniversityUkjentAtrieflimmer | AtriefladderForente stater
-
US Department of Veterans AffairsFullførtHypertensjon | SukkersykeForente stater
-
Taipei Medical UniversityFullført
-
NHS LothianQueen Margaret UniversityUkjent
-
Beth Israel Deaconess Medical CenterFullførtOrgandonorregistrering | OrgandonasjonsutdanningForente stater
-
Guangzhou Blood CenterFullført
-
University of Illinois at Urbana-ChampaignUniversity of Minnesota; The University of The West IndiesFullført