Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
18/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Not specified

Trial type

Not Specified

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 patient’s family physicians for both groups. In the usual care group, this information will be sent to the patient’s 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 measures

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

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

Sponsor information

Organisation

Sunnybrook and Women's College Health Sciences Ctr (Canada)

Sponsor details

2075 Bayview Avenue
Toronto
M4N 3M5
Canada

Sponsor type

Not defined

Website

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16595786

Publication citations

  1. 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.

Additional files

Editorial Notes