Diabetes MellitusMEDIC-1NCT00554671
Pharmacist-led Group Medical Visits to Help With Diabetes Management
A study testing Algorithm driven medication titration, Monitoring and Group support in people with Diabetes Mellitus and Cardiovascular Diseases, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
This is a multi-site open label randomized controlled study of patients with type 2 diabetes undergoing pharmacist-led group medical visits that include education by a multi-disciplinary personnel, behavioral modification and pharmacotherapy case management vs. usual care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Diseases
- What is being tested?
- Algorithm driven medication titration, Monitoring and Group support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2008to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diabetic veterans with HbA1c >7.0% and at least one of the following:
- being a smoker (any cigarette smoking < 30 days)
- having an LDL >100 mg/dl or a blood pressure >130/80 mm Hg documented in at least two occasions within the last 6 months
- able to participate and discuss their DM and cardiac risk control in a group setting and sign informed consent
Who cannot join
- patients without eligible cardiac risk factors within the last 6 months
- those who are unable to attend the group sessions
- or disease conditions such as psychiatric instability (acutely suicidal, psychotic) or organic brain injury that preclude them from performing DM self-care
- patients with conditions that would preclude them from standard algorithm-based medication dose titrations such as those who are pregnant or with complex co-morbidities as defined by New York Heart Association Class 3 or 4 heart failure, liver cirrhosis, end-stage renal disease on dialysis and end-stage cancer will be excluded from the study
- all women of childbearing age will have a pregnancy test before study enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Pacific Islands Health Care System, Honolulu
Honolulu, Hawaii, 96819-1522
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
About this study
Official title: Group Intervention for DM Guideline Implementation
This is a multi-site open label randomized controlled study of patients with type 2 diabetes undergoing pharmacist-led group medical visits that include education by a multi-disciplinary personnel, behavioral modification and pharmacotherapy case management vs. usual care
Read the detailed description
Project Background: Diabetes, hypertension, and dyslipidemia are chronic diseases that can lead to heart attack and stroke, and require interventions at patient and organizational levels to promote sustainable lifestyle and medication changes for cardiac risk reduction that are costly. Group intervention has emerged as a potentially cost-saving patient-centered approach to help achieve the necessary lifestyle and medication changes for the treatment of some chronic diseases, but its efficacy in absence of direct physician participation is not well demonstrated in diabetes. Our preliminary data have shown that our pharmacist-based, group diabetes management program at the Providence VAMC has achieved significant improvements in glycemic control and variable success toward improvement in blood pressure and lipid control in type 2 diabetic patients, through education, behavioral intervention and aggressive pharmacotherapy in 4 weekly group sessions. However, we do not know the long-term sustainability of this intervention, the exportability, the costs to the VA and the health-related quality-of-life implications of patients enrolled in our programs.
Project Objectives: To assess whether a non-physician-based, group diabetes behavioral and pharmacotherapy intervention program for 12 months will: 1. improve cardiac risk factors, 2. improve health-related quality-of-life, 3. add only minimal institutional cost; when compared to usual care in veterans with type 2 diabetes.
Project Methods: We propose a 3-site randomized-controlled study to test the efficacy of a pharmacist-based, group diabetes behavioral and pharmacotherapy intervention program (treatment arm) for 13 months vs. usual care (control arm) in achieving cardiac risk reduction in type 2 diabetic patients with Hemoglobin A1c >7% and at least one other cardiac risk factor such as smoking, hyperlipidemia or hypertension not at national guideline recommended goals. The interventions in the treatment arm will consist of two phases. Phase 1 (intensive intervention) consists of weekly group sessions of education by a nurse, a physical therapist, and a dietician; and behavioral modification and medication titration by a clinical pharmacist targeting the control of glycemia, smoking, blood pressure, and lipids for 4 weeks. Phase 2 consists of quarterly booster sessions for 1 year to prevent relapse. Patients in the control arm will continue on usual care. Our study endpoints will be the difference between the 2 groups after 13 months of study enrollment in: 1) hemoglobin a1c, blood pressure, LDL cholesterol and smoking 2) health-related quality of life (SF-36V) scores, and 3) healthcare costs from the VA perspective. A total of 250 patients will be enrolled from 3 VAMC sites and followed for 13 months.
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases
- Being tested
- Algorithm driven medication titration, Monitoring, Group support, Self efficacy
- Keywords
- Diabetes Mellitus, Clinical pharmacists, guideline adherence, group medical visits, behavioral modification, pharmacotherapy
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm driven medication titrationOther
Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
MonitoringBehavioural
Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
Group supportBehavioural
Peer support are provided in the group setting
Self efficacyBehavioural
Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-led Group Visits | Experimental | Algorithm driven medication titration, Behavioral: Monitoring, Behavioral: Group support, Behavioral: Self efficacy Receives: Other: Algorithm driven medication titration; Behavioral: Monitoring; Behavioral: Group support; Behavioral: Self efficacy |
| Usual Care | No intervention | Patient continues on usual care for diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Hemoglobin A1c levels at 6 months
Measured: 6 months
Hemoglobin A1c
hemoglobin A1c levels at 13 months
Measured: 13 months
Secondary outcomes (2)
Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment
Medical Outcomes Study 36-Item Short Form Survey (SF-36) is a popular, multi-purpose health status survey that addresses quality of life from physical and mental health perspectives. SF-36v is the survey adapted for veterans. Items are summed and averaged in two subscores, the Physical Composite Summary Score and the Mental Composite Summary Score, and scaled to a range of 0 to 100, with lower scores denoting poorer health.
Measured: Baseline and 13 months
Health-care Costs to the VHA
The reported values represent the "Total VHA expenditure per person". Institutional costs from health service utilization on the study patients during and 13 months after the intervention. Baseline is considered time 0.
Measured: 13 months (during study) and 13 months (after the study) = 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startMay 2008
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Wen-Chih H Wu, MD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554671
- Sponsor's protocol ID
- IAB 06-269
- Acronym
- MEDIC-1
- Status last verified
- Jul 2018
- First submitted
- 5 Nov 2007
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Taveira TH, Pirraglia PA, Cohen LB, Wu WC. Efficacy of a pharmacist-led cardiovascular risk reduction clinic for diabetic patients with and without mental health conditions. Prev Cardiol. 2008 Fall;11(4):195-200. doi: 10.1111/j.1751-7141.2008.00008.x.
PubMed 19476571Wu WC, Taveira TH, Jeffery S, Jiang L, Tokuda L, Musial J, Cohen LB, Uhrle F. Costs and effectiveness of pharmacist-led group medical visits for type-2 diabetes: A multi-center randomized controlled trial. PLoS One. 2018 Apr 19;13(4):e0195898. doi: 10.1371/journal.pone.0195898. eCollection 2018.
PubMed 29672567
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Intervention for DM Guideline Implementation
- ClinicalTrials.gov ID
- NCT00554671
- Acronym / sponsor ID
- MEDIC-1 / IAB 06-269
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- Diabetes Mellitus, Clinical pharmacists, guideline adherence, group medical visits, behavioral modification, pharmacotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- May 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Posted 31 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-site open label randomized controlled study of patients with type 2 diabetes undergoing pharmacist-led group medical visits that include education by a multi-disciplinary personnel, behavioral modification and pharmacotherapy case management vs. usual care
Detailed description
Project Background: Diabetes, hypertension, and dyslipidemia are chronic diseases that can lead to heart attack and stroke, and require interventions at patient and organizational levels to promote sustainable lifestyle and medication changes for cardiac risk reduction that are costly. Group intervention has emerged as a potentially cost-saving patient-centered approach to help achieve the necessary lifestyle and medication changes for the treatment of some chronic diseases, but its efficacy in absence of direct physician participation is not well demonstrated in diabetes. Our preliminary data have shown that our pharmacist-based, group diabetes management program at the Providence VAMC has achieved significant improvements in glycemic control and variable success toward improvement in blood pressure and lipid control in type 2 diabetic patients, through education, behavioral intervention and aggressive pharmacotherapy in 4 weekly group sessions. However, we do not know the long-term sustainability of this intervention, the exportability, the costs to the VA and the health-related quality-of-life implications of patients enrolled in our programs.
Project Objectives: To assess whether a non-physician-based, group diabetes behavioral and pharmacotherapy intervention program for 12 months will: 1. improve cardiac risk factors, 2. improve health-related quality-of-life, 3. add only minimal institutional cost; when compared to usual care in veterans with type 2 diabetes.
Project Methods: We propose a 3-site randomized-controlled study to test the efficacy of a pharmacist-based, group diabetes behavioral and pharmacotherapy intervention program (treatment arm) for 13 months vs. usual care (control arm) in achieving cardiac risk reduction in type 2 diabetic patients with Hemoglobin A1c >7% and at least one other cardiac risk factor such as smoking, hyperlipidemia or hypertension not at national guideline recommended goals. The interventions in the treatment arm will consist of two phases. Phase 1 (intensive intervention) consists of weekly group sessions of education by a nurse, a physical therapist, and a dietician; and behavioral modification and medication titration by a clinical pharmacist targeting the control of glycemia, smoking, blood pressure, and lipids for 4 weeks. Phase 2 consists of quarterly booster sessions for 1 year to prevent relapse. Patients in the control arm will continue on usual care. Our study endpoints will be the difference between the 2 groups after 13 months of study enrollment in: 1) hemoglobin a1c, blood pressure, LDL cholesterol and smoking 2) health-related quality of life (SF-36V) scores, and 3) healthcare costs from the VA perspective. A total of 250 patients will be enrolled from 3 VAMC sites and followed for 13 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-led Group Visits | Experimental | Other: Algorithm driven medication titration, Behavioral: Monitoring, Behavioral: Group support, Behavioral: Self efficacyAlgorithm driven medication titration, Behavioral: Monitoring, Behavioral: Group support, Behavioral: Self efficacy |
| Usual Care | No intervention | –Patient continues on usual care for diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being a smoker (any cigarette smoking < 30 days)
- having an LDL >100 mg/dl or a blood pressure >130/80 mm Hg documented in at least two occasions within the last 6 months
- able to participate and discuss their DM and cardiac risk control in a group setting and sign informed consent
Key exclusion criteria (5 listed)
- patients without eligible cardiac risk factors within the last 6 months
- those who are unable to attend the group sessions
- or disease conditions such as psychiatric instability (acutely suicidal, psychotic) or organic brain injury that preclude them from performing DM self-care
- patients with conditions that would preclude them from standard algorithm-based medication dose titrations such as those who are pregnant or with complex co-morbidities as defined by New York Heart Association Class 3 or 4 heart failure, liver cirrhosis, end-stage renal disease on dialysis and end-stage cancer will be excluded from the study
- all women of childbearing age will have a pregnancy test before study enrollment
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 |
|---|---|---|
| Algorithm driven medication titrationClinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes | Other | Pharmacist-led Group Visits |
| MonitoringClinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals | Behavioural | Pharmacist-led Group Visits |
| Group supportPeer support are provided in the group setting | Behavioural | Pharmacist-led Group Visits |
| Self efficacyPatients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision | Behavioural | Pharmacist-led Group Visits |
Primary outcome
Hemoglobin A1c
Time frame: 6 months
Hemoglobin A1c levels at 6 months
Hemoglobin A1c
Time frame: 13 months
hemoglobin A1c levels at 13 months
2 secondary outcomes
Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment
Time frame: Baseline and 13 months
Health-care Costs to the VHA
Time frame: 13 months (during study) and 13 months (after the study) = 26 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19476571Taveira TH, Pirraglia PA, Cohen LB, Wu WC. Efficacy of a pharmacist-led cardiovascular risk reduction clinic for diabetic patients with and without mental health conditions. Prev Cardiol. 2008 Fall;11(4):195-200. doi: 10.1111/j.1751-7141.2008.00008.x.
- Derived from this study: PubMed 29672567Wu WC, Taveira TH, Jeffery S, Jiang L, Tokuda L, Musial J, Cohen LB, Uhrle F. Costs and effectiveness of pharmacist-led group medical visits for type-2 diabetes: A multi-center randomized controlled trial. PLoS One. 2018 Apr 19;13(4):e0195898. doi: 10.1371/journal.pone.0195898. eCollection 2018.
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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 H Wu, MD principal investigator
Providence VA Medical Center, Providence, RI
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm driven medication titration, Monitoring and Group support in people with Diabetes Mellitus and Cardiovascular Diseases, run by VA Office of Research and Development at 3 sites 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 4 inclusion and 5 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 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin A1c (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00554671, which also lists 2 linked publications.
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 11 Jul 2018.