Disease ManagementDECIDENCT00498147
Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program
An observational study of Disease Management and Diabetes Complications, run by Group Health Centre at 1 site in Canada.
Trial summary
The primary objective of this study is to identify whether cardiovascular complication rates are lower in patients who participate in managed diabetes care, in comparison to provincial and national rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease Management, Diabetes Complications, Diabetic Vascular Complications
- What is being tested?
- ADEC Program
- Type of treatment
- Pill or oral medicine
- How many people
- 1,213 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Jul 2010
- Phase
- Observational
- 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
Study population: Ambulatory patients of the Group Health Centre who are over the age of 18 years with a confirmed diagnosis of diabetes mellitus and who are enrolled in the Algoma Diabetes Education and Care (ADEC) program. ADEC is a managed diabetes care program and part of the Group Health Centre (GHC), a multi-specialty, interdisciplinary, ambulatory care facility located in Sault Ste. Marie, a northern Ontario community. With diagnostic services and a comprehensive electronic medical record, GHC provides health care to most of the community's population of approximately 75,000.
Who may be able to join
- Ambulatory patients over the age of 18 years with diabetes mellitus.
- Current enrolment in ADEC program (>6 months)or new enrolment in ADEC program (<6 months).
- Confirmed diagnosis of diabetes mellitus, according to the current Canadian Diabetes Guidelines.
- Informed consent provided
Who cannot join
- History of only gestational diabetes.
- Non-GHC member.
- GHC patients with diabetes who do not attend the ADEC program.
- Unable to give informed consent.
- Any conditions/circumstances that prevent the patient from attending ADEC sessions or participating fully in the program.
- Refusal to allow research staff access to medical records, including hospital charts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes?
The primary objective of this study is to identify whether cardiovascular complication rates are lower in patients who participate in managed diabetes care, in comparison to provincial and national rates. This study will involve an electronic medical record (EMR) chart audit, augmented by a manual review of hospital and other pertinent medical records, as necessary.
Read the detailed description
The DECIDE study will identify whether cardiovascular complication rates (the composite rate of myocardial infarction (MI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG), stroke, carotid endarterectomy, peripheral revascularization, and peripheral amputation) are lower in patients who participate in managed diabetes care by ADEC in comparison to provincial and national rates. Comparison statistics will be provided by the Institute of Evaluative Sciences (ICES) Atlas 2003 and other Diabetes studies such as the 2005 DICE study. Complications such as nephropathy and retinopathy will be documented, along with hospitalization rates and all cause mortality. Clinical outcomes relevant to diabetes management such as blood pressure and lipids will also be compared.
- Conditions
- Disease Management, Diabetes Complications, Diabetic Vascular Complications, Diabetic Neuropathy, Diabetic Nephropathy, Diabetic Retinopathy
- Being tested
- ADEC Program
- Keywords
- amputation, angina, angiography, angioplasty, arterial disease, artery disease, bypass, CABG, cad, carotid, cerebral accident, CHF, CRF, CVA, endarterectomy, heart attack, heart failure, infarct, kidney disease, kidney failure
- Medical subject headings
- Diabetes Complications, Diabetic Angiopathies, Diabetic Neuropathies, Diabetic Nephropathies, Diabetic Retinopathy, Angina Pectoris, Coronary Artery Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADEC ProgramOther
Also called Managed Diabetes Care
Interventions (managed diabetes care) employed by the ADEC Program include: diabetes education, nutrition care, individual and group counseling sessions, foot care, and insulin and oral diabetes medication adjustments with a signed medical directive. ADEC Diabetes Educators (Registered Dietitians and Registered Nurses) will use adult education principles throughout the education process and promote self-care by encouraging responsibility and promoting a positive attitude towards acceptance of diabetes. All patients will be encouraged to self-monitor their blood glucose at home. Team member collaboration and with other agencies to promote a total client care approach to diabetes management will be employed.
| Study group | Role | What they receive |
|---|---|---|
| ADEC <6months | Patients new to the ADEC program who will be provided the ADEC interventions (prospective study) Receives: Other: ADEC Program | |
| ADEC >6months | Patients who have been with the ADEC program as early as 2002 (coincides with ADEC's EMR initiation date) who continue to be provided the ADEC interventions (combined retrospective/prospective study) Receives: Other: ADEC Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates
Measured: 1 year
Secondary outcomes (1)
The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease ManagementStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 1,213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Group Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Silvana Spadafora, MD FRCPC, Principal investigator, The Group Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498147
- Sponsor's protocol ID
- DECIDE
- Acronym
- DECIDE
- Status last verified
- Oct 2009
- First submitted
- 6 Jul 2007
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes?
- ClinicalTrials.gov ID
- NCT00498147
- Acronym / sponsor ID
- DECIDE / DECIDE
- Conditions
- Disease Management, Diabetes Complications, Diabetic Vascular Complications, Diabetic Neuropathy, Diabetic Nephropathy, Diabetic Retinopathy
- Keywords
- amputation, angina, angiography, angioplasty, arterial disease, artery disease, bypass, CABG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,213 participants (actual)
- Lead sponsor
- Group Health CentreUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2007
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 9 Jul 2007 (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.
The primary objective of this study is to identify whether cardiovascular complication rates are lower in patients who participate in managed diabetes care, in comparison to provincial and national rates. This study will involve an electronic medical record (EMR) chart audit, augmented by a manual review of hospital and other pertinent medical records, as necessary.
Detailed description
The DECIDE study will identify whether cardiovascular complication rates (the composite rate of myocardial infarction (MI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG), stroke, carotid endarterectomy, peripheral revascularization, and peripheral amputation) are lower in patients who participate in managed diabetes care by ADEC in comparison to provincial and national rates. Comparison statistics will be provided by the Institute of Evaluative Sciences (ICES) Atlas 2003 and other Diabetes studies such as the 2005 DICE study. Complications such as nephropathy and retinopathy will be documented, along with hospitalization rates and all cause mortality. Clinical outcomes relevant to diabetes management such as blood pressure and lipids will also be compared.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADEC <6months | – | Other: ADEC ProgramPatients new to the ADEC program who will be provided the ADEC interventions (prospective study) |
| ADEC >6months | – | Other: ADEC ProgramPatients who have been with the ADEC program as early as 2002 (coincides with ADEC's EMR initiation date) who continue to be provided the ADEC interventions (combined retrospective/prospective study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory patients of the Group Health Centre who are over the age of 18 years with a confirmed diagnosis of diabetes mellitus and who are enrolled in the Algoma Diabetes Education and Care (ADEC) program. ADEC is a managed diabetes care program and part of the Group Health Centre (GHC), a multi-specialty, interdisciplinary, ambulatory care facility located in Sault Ste. Marie, a northern Ontario community. With diagnostic services and a comprehensive electronic medical record, GHC provides health care to most of the community's population of approximately 75,000.
Key inclusion criteria (4 listed)
- Ambulatory patients over the age of 18 years with diabetes mellitus.
- Current enrolment in ADEC program (>6 months)or new enrolment in ADEC program (<6 months).
- Confirmed diagnosis of diabetes mellitus, according to the current Canadian Diabetes Guidelines.
- Informed consent provided
Key exclusion criteria (6 listed)
- History of only gestational diabetes.
- Non-GHC member.
- GHC patients with diabetes who do not attend the ADEC program.
- Unable to give informed consent.
- Any conditions/circumstances that prevent the patient from attending ADEC sessions or participating fully in the program.
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 |
|---|---|---|
| ADEC ProgramAlso: Managed Diabetes CareInterventions (managed diabetes care) employed by the ADEC Program include: diabetes education, nutrition care, individual and group counseling sessions, foot care, and insulin and oral diabetes medication adjustments with a signed medical directive. ADEC Diabetes Educators (Registered Dietitians and Registered Nurses) will use adult education principles throughout the education process and promote self-care by encouraging responsibility and promoting a positive attitude towards acceptance of diabetes. All patients will be encouraged to self-monitor their blood glucose at home. Team member collaboration and with other agencies to promote a total client care approach to diabetes management will be employed. | Other | ADEC <6months, ADEC >6months |
Primary outcome
Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates
Time frame: 1 year
1 secondary outcome
The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
- Group Health Centre websiteLink provided by the sponsor.
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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.
Silvana Spadafora, MD FRCPC principal investigator
The Group Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease Management and Diabetes Complications, run by Group Health Centre at 1 site in Canada.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates (time frame: 1 year). 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 6 Oct 2009.