N/A
N=250
Pharmacist-led Group Medical Visits to Help With Diabetes Management
Diabetes Mellitus · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00554671 ↗Enrolled (actual)
250
Serious AEs
32.8%
Results posted
Dec 2014
Primary outcome: Primary: Hemoglobin A1c — 7.8; 8.1 percent Hemoglobin A1c
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Algorithm driven medication titration (Other); Monitoring (Behavioral); Group support (Behavioral); Self efficacy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c |
7.9; 8.0 | — |
| PRIMARY Hemoglobin A1c |
7.9; 8.0 | — |
| SECONDARY Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment |
39.2; 39.3; 39.6; 39.1; 48.8; 50.4 | — |
| SECONDARY Health-care Costs to the VHA |
22062; 15200; 4656; 2645; -1575; 2360 | — |
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
Eligibility Criteria
Inclusion Criteria
Diabetic veterans with HbA1c >7.0% and at least one of the following:
- being a smoker (any cigarette smoking 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00554671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.