DREAM3 - Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

ISRCTN	ISRCTN34318453
DOI	https://doi.org/10.1186/ISRCTN34318453
Protocol serial number	DCT-52188
Sponsor	Sunnybrook and Women's College Health Sciences Ctr (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-52188), Pfizer (Canada)

Submission date: 09/09/2005
Registration date: 09/09/2005
Last edited: 03/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sheldon William Tobe
Scientific

Sunnybrook & Women's College Health Sciences Ctre
Room A240
2075 Bayview Avenue
Toronto
M4N 3M5
Canada

Phone	+1 416-480-6901
Email	sheldon.tobe@sw.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	DREAM3 - Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples: a randomised controlled trial
Study acronym	DREAM3
Study objectives	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(s)	Research Ethics Board of the Sunnybrook and Women's College, 13 August, 2001
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Mean change in Systolic Blood Pressure from baseline to final visit at 12 months.
Key secondary outcome measure(s)	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
Completion date	01/03/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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).
Key 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.
Date of first enrolment	21/11/2001
Date of final enrolment	01/03/2004

Locations

Countries of recruitment

Canada

Study participating centre

Sunnybrook & Women's College Health Sciences Ctre

Toronto
M4N 3M5
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/04/2006		Yes	No

Editorial Notes

HF 03/10/2017: corrected pub stage.