HypertensionDREAM3NCT00741702
Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples
A study testing Nurse administered treatment algorithm in people with Hypertension and Diabetes Mellitus, run by Sunnybrook Health Sciences Centre.
Trial summary
This randomized controlled trial was designed to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus
- What is being tested?
- Nurse administered treatment algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Mar 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>= 18 yr
- Type 2 diabetes mellitus
- Persistent hypertension (systolic pressure >= 130 mmHg, diastolic pressure >= 80 mm Hg, or both)
Who cannot join
- use of beta blocker
- women of child-bearing age not able to use a reliable method of birth control
- Connective tissue disorder
- Severe systemic or malignant disease
- Inability to follow the protocol
- Bilateral renal artery stenosis and other causes of secondary hypertension
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- Serum creatinine level > 250 micromol/L
- cerebrovascular even within 6 mo
- valvular heart disease
- unstable angina
- Myocardial infarction
- Revascularization procedure within 3 mo before study recruitment
- heart failure
- cardiac arrhythmia requiring medical treatment or heart block
- active hepatic disease
About this study
This randomized controlled trial was designed to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes.
Read the detailed description
Two community-based strategies for controlling hypertension in First Nations people with existing hypertension and diabetes were compared. In the intervention group, a home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. In the control group, treatment decisions were made by each subject's primary care physician. The primary outcome measure was the difference between the 2 groups in teh change in systolic blood pressure after 12 months.
- Conditions
- Hypertension, Diabetes Mellitus
- Being tested
- Nurse administered treatment algorithm
- Keywords
- Hypertension, Type 2 diabetes, First Nations populations
- Medical subject headings
- Hypertension, Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse administered treatment algorithmOther
Start with Irbesartan 150 mg/d; check BP in 6 wks, if BP >=130/80 mm HF, 300 mg/d irbesartan; check BP at next visit, if BP>= 130/80 mm Hg, add HCTZ 12.5 mg/d; check BP at next visit, if BP>=130/80 mm Hg, add verapamil 180 mg/d; check BP at next visit, if BP>=13/80 mm Hg, increase verapamil to 240 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. Receives: Other: Nurse administered treatment algorithm |
| Control group | No intervention | Treatment decisions were made by each subject's primary care physician. Participants in this group received usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
Measured: 12 months
Secondary outcomes (1)
Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startSep 2001
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Pfizer
- Responsible party
- Principal investigator, Sheldon Tobe, Sunnybrook Health Sciences Centre
- Investigators
- Sheldon Tobe, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741702
- Sponsor's protocol ID
- 231-2001
- Acronym
- DREAM3
- Status last verified
- May 2012
- First submitted
- 25 Aug 2008
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples
- ClinicalTrials.gov ID
- NCT00741702
- Acronym / sponsor ID
- DREAM3 / 231-2001
- Conditions
- Hypertension, Diabetes Mellitus
- Keywords
- Hypertension, Type 2 diabetes, First Nations populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Pfizer
- Study start
- Sep 2001
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial was designed to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes.
Detailed description
Two community-based strategies for controlling hypertension in First Nations people with existing hypertension and diabetes were compared. In the intervention group, a home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. In the control group, treatment decisions were made by each subject's primary care physician. The primary outcome measure was the difference between the 2 groups in teh change in systolic blood pressure after 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Nurse administered treatment algorithmA home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. |
| Control group | No intervention | –Treatment decisions were made by each subject's primary care physician. Participants in this group received usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>= 18 yr
- Type 2 diabetes mellitus
- Persistent hypertension (systolic pressure >= 130 mmHg, diastolic pressure >= 80 mm Hg, or both)
Key exclusion criteria (15 listed)
- use of beta blocker
- women of child-bearing age not able to use a reliable method of birth control
- Connective tissue disorder
- Severe systemic or malignant disease
- Inability to follow the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse administered treatment algorithmStart with Irbesartan 150 mg/d; check BP in 6 wks, if BP >=130/80 mm HF, 300 mg/d irbesartan; check BP at next visit, if BP>= 130/80 mm Hg, add HCTZ 12.5 mg/d; check BP at next visit, if BP>=130/80 mm Hg, add verapamil 180 mg/d; check BP at next visit, if BP>=13/80 mm Hg, increase verapamil to 240 mg/d | Other | Intervention group |
Primary outcome
systolic blood pressure
Time frame: 12 months
1 secondary outcome
Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon Tobe, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Nurse administered treatment algorithm in people with Hypertension and Diabetes Mellitus, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.