Coronary Arteriosclerosis, Diabetes, Dyslipidemia, Hypertension
Conditions
Brief summary
The purpose of this research is to study whether a multidisciplinary education in Diabetes and intervention for cardiac risk reduction in a group setting to modify patient behavior and adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and lipid control.
Interventions
BEHAVIORALBehavioral counseling and peer support
Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention
BEHAVIORALInteractive Education
interactive lectures with hands-on learning
BEHAVIORALRole modeling
learning from peers with similar disease and problems
PROCEDUREPharmacologic case management
provided by clinical pharmacists following pre-established algorithms
Sponsors
Rhode Island Foundation
Providence VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All diabetic veterans with a Hb-A1c between 7.0- 9.0 % within the last 6 months will be eligible for the study
Exclusion criteria
* Patients without an Hb-A1c checked within the last 6 months. * Patients who are unable to attend the group sessions, either because of lack of transportation, psychiatric instability (suicidal, psychotic), or organic brain injury that preclude them from diabetes self-care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | 4 months | The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C \<7%, SBP \<130 mm Hg, diastolic blood pressure (DBP) \<80 mm Hg, and LDL cholesterol \<100 mg/dL (2.6 mmol/L). |
Countries
United States
Participant flow
Recruitment details
Eligible patients were identified by a combination of the review of the VA Medical Center's electronic medical record system and referral by primary care providers. Recruitment started July 2004 and enrollment was completed by May 2007.
Pre-assignment details
Once eligibility confirmed and consent signed, participants were randomized. There were no wash-out or run-in period.
Participants by arm
| Arm | Count |
|---|---|
| MEDIC Multidisciplinary education and diabetes intervention for cardiac risk reduction
Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms
Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention
Role modeling : learning from peers with similar disease and problems
Interactive Education : interactive lectures with hands-on learning | 58 |
| Usual Care usual care | 51 |
| Total | 109 |
Baseline characteristics
| Characteristic | Usual Care | MEDIC | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 19 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 39 Participants | 59 Participants |
| Age, Continuous | 66.8 years STANDARD_DEVIATION 10.2 | 62 years STANDARD_DEVIATION 10.3 | 64.4 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 51 participants | 58 participants | 109 participants |
| Sex: Female, Male Female | 0 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 51 Participants | 53 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 58 | 2 / 51 |
| serious Total, serious adverse events | 0 / 58 | 1 / 51 |
Outcome results
Primary
Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg
The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C \<7%, SBP \<130 mm Hg, diastolic blood pressure (DBP) \<80 mm Hg, and LDL cholesterol \<100 mg/dL (2.6 mmol/L).
Time frame: 4 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MEDIC | Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | A1c <7% | 40.4 percentage |
| MEDIC | Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | Systolic Blood Pressure<130mmHg | 65.5 percentage |
| MEDIC | Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | Diastolic Blood Pressure<80mmHg | 87.9 percentage |
| MEDIC | Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | LDL Cholesterol <100mg/dL | 77.2 percentage |
| Usual Care | Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | LDL Cholesterol <100mg/dL | 77.5 percentage |
| Usual Care | Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | A1c <7% | 21.6 percentage |
| Usual Care | Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | Diastolic Blood Pressure<80mmHg | 68.6 percentage |
| Usual Care | Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | Systolic Blood Pressure<130mmHg | 39.9 percentage |