An interventional study of Behavioral counseling and peer support and Interactive Education in Diabetes, Hypertension and Dyslipidemia, sponsored by Providence VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Providence VA Medical Center · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Multidisciplinary education and diabetes intervention for cardiac risk reduction
Behavioral: Behavioral counseling and peer support · Behavioral: Interactive Education · Behavioral: Role modeling · Procedure: Pharmacologic case management
usual care
Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention
interactive lectures with hands-on learning
learning from peers with similar disease and problems
provided by clinical pharmacists following pre-established algorithms
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
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.
| Milestone | MEDIC | Usual Care |
|---|---|---|
| Started | 64 | 54 |
| Completed | 58 | 51 |
| Not completed | 6 | 3 |
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).
| percentage | MEDIC | Usual Care |
|---|---|---|
| A1c <7% | 40.4 | 21.6 |
| Systolic Blood Pressure<130mmHg | 65.5 | 39.9 |
| Diastolic Blood Pressure<80mmHg | 87.9 | 68.6 |
| LDL Cholesterol <100mg/dL | 77.2 | 77.5 |
Collected over Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MEDIC | — | 0/58 (0%) | 11/58 (19%) |
| Usual Care | — | 1/51 (2%) | 2/51 (3.9%) |
| Event | MEDIC | Usual Care |
|---|---|---|
| HospitalizationCardiac disorders | 0/58 | 1/51 |
| Event | MEDIC | Usual Care |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 1/58 | 1/51 |
| hypoglycemiaBlood and lymphatic system disorders | 0/58 | 1/51 |
| Lower Back PainMusculoskeletal and connective tissue disorders | 1/58 | 0/51 |
| SyncopeCardiac disorders | 1/58 | 0/51 |
| Cellulitis AbcessSkin and subcutaneous tissue disorders | 1/58 | 0/51 |
| LacerationSkin and subcutaneous tissue disorders | 1/58 | 0/51 |
| BlepharitisEye disorders | 1/58 | 0/51 |
| Toe infectionSkin and subcutaneous tissue disorders | 1/58 | 0/51 |
| Ear acheEar and labyrinth disorders | 1/58 | 0/51 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 1/58 | 0/51 |
Age, mean in years; Gender, % male; Baseline level of glycemic control
| Age, Categorical(Participants) | MEDIC | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 39 | 20 | 59 |
| >=65 years | 19 | 31 | 50 |
| Age, Continuous(years) | MEDIC | Usual Care | Total |
|---|---|---|---|
| Mean | 62 ± 10.3 | 66.8 ± 10.2 | 64.4 ± 10.5 |
| Sex: Female, Male(Participants) | MEDIC | Usual Care | Total |
|---|---|---|---|
| Female | 5 | 0 | 5 |
| Male | 53 | 51 | 104 |
| Region of Enrollment(participants) | MEDIC | Usual Care | Total |
|---|---|---|---|
| United States | 58 | 51 | 109 |
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Providence VA Medical Center