Diabetes, Dyslipidemia, Hypertension
Conditions
Keywords
Group Intervention, Pharmacotherapy, Behavioral Modification, Diabetes
Brief summary
Our study intends to test the efficacy of pharmacist-led group interventions on a weekly basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure.
Detailed description
Our project intends to study the 6-month efficacy of a pharmacist-led group intervention program that simultaneously target diabetes, hypertension and dyslipidemia. We hypothesize that pharmacist-led group interventions on a weekly basis for 4-weeks then on a monthly basis for 5 additional months may achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure. We are proposing a pilot randomized controlled study to test the efficacy and feasibility of this approach.
Interventions
OTHERMEDIC
Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
Sponsors
Sandra A. Daugherty 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 85 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes mellitus, * \>18 years old, * with a documented HbA1c more than 7.0%, * an LDL cholesterol \>100 mg/dl AND a blood pressure \>130/80 mm Hg documented at least once in the medical records within the last 6 months, and * willing to comply with the study interventions will be eligible for the study.
Exclusion criteria
* pregnancy, * unable to attend the group sessions, * disease conditions such as psychiatric instability (acutely suicidal, psychotic) or organic brain injury that preclude them from performing diabetes self-care, * enrolled in the Providence VAMC's Telehealth program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study | 6 months | Hemoglobin A1C target was \< 7% LDL cholesterol goal of \< 100mg/dl or \<70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of \<130mm Hg |
Countries
United States
Participant flow
Recruitment details
Veterans of the Providence VA Medical Center were eligible for the study. Dates of recruitment period were 2007-2009.
Participants by arm
| Arm | Count |
|---|---|
| MEDIC Intervention Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups. | 50 |
| Usual Care Patient continued on usual care | 49 |
| Total | 99 |
Baseline characteristics
| Characteristic | MEDIC Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 69.8 years STANDARD_DEVIATION 10.7 | 67.2 years STANDARD_DEVIATION 9.4 | 68.5 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment United States | 50 participants | 49 participants | 99 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 50 Participants | 47 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 50 | 3 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 |
Outcome results
Primary
Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study
Hemoglobin A1C target was \< 7% LDL cholesterol goal of \< 100mg/dl or \<70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of \<130mm Hg
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MEDIC Intervention | Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study | Percentage achieving A1C of <7% | 40.8 participants |
| MEDIC Intervention | Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study | Percentage achieving LDL at goal | 82.0 participants |
| MEDIC Intervention | Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study | Percentage achieving systolic Blood Pressure < 130 | 58.0 participants |
| MEDIC Intervention | Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study | Percentage Achieving combined goal A1c, SBP, LDL | 16.0 participants |
| Usual Care | Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study | Percentage Achieving combined goal A1c, SBP, LDL | 4.1 participants |
| Usual Care | Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study | Percentage achieving A1C of <7% | 20.4 participants |
| Usual Care | Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study | Percentage achieving systolic Blood Pressure < 130 | 32.7 participants |
| Usual Care | Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study | Percentage achieving LDL at goal | 65.3 participants |