DiabetesPhase 3NCT00358033
Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic
A Phase 3 study testing Counseling, Interactive Education and Group Support in people with Diabetes and Dyslipidemia, run by Providence VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a combined behavioral and pharmacological intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Dyslipidemia, Hypertension
- What is being tested?
- Counseling, Interactive Education and Group Support
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to May 2008
- Phase
- Phase 3
- 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
- Previous enrollment in Cardiovascular Risk Reduction Clinic (CRRC)
- Eligible for CRRC discharge:
- For DM patients:
- HbA1c < 7.0 %,
- BP < 130/85 mm Hg , and
- LDL < 100 mg/dl;
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- For Non-DM patients:
- BP < 140/90 mm Hg, and
- LDL < 100 mg/dl;
- Able and willing to sign informed consent.
Who cannot join
- Presence of conditions that might limit long-term compliance (eg, dementia, acute psychiatric decompensation within the previous 6 months, unstable psychiatric disorder);
- Metastatic disease or terminal illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Different Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged From Cardiovascular Risk Reduction Clinic
The purpose of this study is to determine whether a combined behavioral and pharmacological intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care.
- Conditions
- Diabetes, Dyslipidemia, Hypertension, Coronary Atherosclerosis
- Being tested
- Counseling, Interactive Education, Group Support, Pharmacologic case management
- Medical subject headings
- Diabetes Mellitus, Dyslipidemias, Hypertension, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Interactive EducationBehavioural
Group SupportBehavioural
Pharmacologic case managementProcedure or surgery
Provided by clinical pharmacists
| Study group | Role | What they receive |
|---|---|---|
| group intervention | Experimental | pharmacist-led group intervention in behavioral and pharmacologic therapy Receives: Behavioral: Counseling; Behavioral: Interactive Education; Behavioral: Group Support; Procedure: Pharmacologic case management |
| individual | Active comparator | pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction Receives: Behavioral: Counseling; Procedure: Pharmacologic case management |
| usual care | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.
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 posted28 Jul 2006 (estimated)
- Study startJul 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Wen-Chih Wu, Providence VA Medical Center
- Investigators
- Wen-Chih Wu, MD, Principal investigator, Providence VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358033
- Sponsor's protocol ID
- 12712
- Status last verified
- Apr 2014
- First submitted
- 24 Jul 2006
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged From Cardiovascular Risk Reduction Clinic
- ClinicalTrials.gov ID
- NCT00358033
- Acronym / sponsor ID
- 12712
- Conditions
- Diabetes, Dyslipidemia, Hypertension, Coronary Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Providence VA Medical CenterUS federal agency
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 28 Jul 2006 (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 purpose of this study is to determine whether a combined behavioral and pharmacological intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group intervention | Experimental | Behavioral: Counseling, Behavioral: Interactive Education, Behavioral: Group Support, Procedure: Pharmacologic case managementpharmacist-led group intervention in behavioral and pharmacologic therapy |
| individual | Active comparator | Behavioral: Counseling, Procedure: Pharmacologic case managementpharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction |
| usual care | No intervention | –usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Previous enrollment in Cardiovascular Risk Reduction Clinic (CRRC)
- Eligible for CRRC discharge:
- Able and willing to sign informed consent.
Key exclusion criteria (2 listed)
- Presence of conditions that might limit long-term compliance (eg, dementia, acute psychiatric decompensation within the previous 6 months, unstable psychiatric disorder);
- Metastatic disease or terminal illness
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 |
|---|---|---|
| Counseling | Behavioural | group intervention, individual |
| Interactive Education | Behavioural | group intervention |
| Group Support | Behavioural | group intervention |
| Pharmacologic case managementProvided by clinical pharmacists | Procedure or surgery | group intervention, individual |
Primary outcome
The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.
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 Apr 2014.
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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.
Wen-Chih Wu, MD principal investigator
Providence VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Counseling, Interactive Education and Group Support in people with Diabetes and Dyslipidemia, run by Providence VA Medical Center at 1 site in United States.
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 10 inclusion and 2 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 Apr 2014. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c. (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 Apr 2014.