DREAM3 - Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples
| ISRCTN | ISRCTN34318453 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34318453 |
| Secondary identifying numbers | DCT-52188 |
- 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
Scientific
Sunnybrook & Women's College Health Sciences Ctre
Room A240
2075 Bayview Avenue
Toronto
M4N 3M5
Canada
| Phone | +1 416-480-6901 |
|---|---|
| sheldon.tobe@sw.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 21/11/2001 |
| Completion date | 01/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
M4N 3M5
Canada
Sponsor information
Sunnybrook and Women's College Health Sciences Ctr (Canada)
Hospital/treatment centre
Hospital/treatment centre
2075 Bayview Avenue
Toronto
M4N 3M5
Canada
"ROR" |
https://ror.org/03wefcv03 |
|---|
Funders
Funder type
Industry
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-52188)
No information available
Pfizer (Canada)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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.
