Contact information
Type
Scientific
Primary contact
Dr Sheldon William Tobe
ORCID ID
Contact details
Sunnybrook & Women's College Health Sciences Ctre
Room A240
2075 Bayview Avenue
Toronto
M4N 3M5
Canada
+1 416-480-6901
sheldon.tobe@sw.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DCT-52188
Study information
Scientific title
DREAM3 - Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples: a randomised controlled trial
Acronym
DREAM3
Study hypothesis
The DREAM3 study was designed to evaluate the effectiveness of an algorithm of pharmocologic therapy implemented by the home care nurse in a community setting.
Ethics approval
Research Ethics Board of the Sunnybrook and Women's College, 13 August, 2001
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hypertension with diabetes
Intervention
Participants were randomized to either the 1st Nations nurse-administered stepped protocol drug approach or to usual care. The nurse administered stepped protocol approach will involve adding three medications, one at a time, until either the BP is controlled to target (<130/80 mmHg) or the patient is at the maximum dose and number of medications as described in the algorithm. Treatment arm patients will be asked to see their family physicians to review medication changes. The nurse will assess patients in both groups at each visit in the same way. All patient specific advice from each visit will be forwarded to the patients family physicians for both groups. In the usual care group, this information will be sent to the patients primary care physician and the patient will be advised to follow-up with their primary care physician for any required treatment. The nursing assessments will be in addition to the health care the patients normally receive.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Mean change in Systolic Blood Pressure from baseline to final visit at 12 months.
Secondary outcome measures
All at 12 months:
1. Change in diastolic blood pressure between the two groups
2. Changes in urine albumin status
3. Proportion of patients achieving blood pressure targets
4. Adverse events
Overall trial start date
21/11/2001
Overall trial end date
01/03/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Eligible patients were Status Indians with the BTCIHS, age 18 or over (either sex), diagnosed with type 2 diabetes and persistent hypertension (greater than or equal too 130/80 mmHg).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Exclusion criteria included the use of beta-blockers, and women of childbearing age not able to use a reliable method of birth control and an inability to follow protocol.
Recruitment start date
21/11/2001
Recruitment end date
01/03/2004
Locations
Countries of recruitment
Canada
Trial participating centre
Sunnybrook & Women's College Health Sciences Ctre
Toronto
M4N 3M5
Canada
Funders
Funder type
Industry
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-52188)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer (Canada)
Alternative name(s)
Pfizer Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16595786
Publication citations
-
Results
Tobe SW, Pylypchuk G, Wentworth J, Kiss A, Szalai JP, Perkins N, Hartman S, Ironstand L, Hoppe J, Effect of nurse-directed hypertension treatment among First Nations people with existing hypertension and diabetes mellitus: the Diabetes Risk Evaluation and Microalbuminuria (DREAM 3) randomized controlled trial., CMAJ, 2006, 174, 9, 1267-1271, doi: 10.1503/cmaj.050030.