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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 118 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Providence VA Medical Center is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
The record gives a start of Aug 2004, a primary completion of May 2008 and a completion of May 2008. It does not say whether these dates are actual or estimated.
Results were first posted in May 2014, 6 years after primary completion.
How these figures are worked out, and which studies are left out of them.
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