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Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT00357955
Recruitment Status : Completed
First Posted : July 28, 2006
Results First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Sponsor:
Collaborator:
Rhode Island Foundation
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Hypertension
Dyslipidemia
Coronary Arteriosclerosis
Interventions Behavioral: Behavioral counseling and peer support
Behavioral: Interactive Education
Behavioral: Role modeling
Procedure: Pharmacologic case management
Enrollment 118
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.
Arm/Group Title MEDIC Usual Care
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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

usual care
Period Title: Overall Study
Started 64 54
Completed 58 51
Not Completed 6 3
Arm/Group Title MEDIC Usual Care Total
Hide Arm/Group Description

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

usual care Total of all reporting groups
Overall Number of Baseline Participants 58 51 109
Hide Baseline Analysis Population Description
Age, mean in years; Gender, % male; Baseline level of glycemic control
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 51 participants 109 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
  67.2%
20
  39.2%
59
  54.1%
>=65 years
19
  32.8%
31
  60.8%
50
  45.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 51 participants 109 participants
62  (10.3) 66.8  (10.2) 64.4  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 51 participants 109 participants
Female
5
   8.6%
0
   0.0%
5
   4.6%
Male
53
  91.4%
51
 100.0%
104
  95.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants 51 participants 109 participants
58 51 109
1.Primary Outcome
Title Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MEDIC Usual Care
Hide Arm/Group Description:

Multidisciplinary education and diabetes intervention for cardiac risk reduction

Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention

Interactive Education: interactive lectures with hands-on learning

Role modeling: learning from peers with similar disease and problems

Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms

The standard of care to patients with type 2 diabetes is provided by primary care providers at the VA Medical Center through individual clinic visits. The frequency of these visits for patients with diabetes averages approximately 4 months.usual care
Overall Number of Participants Analyzed 58 51
Measure Type: Number
Unit of Measure: percentage
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
Time Frame Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MEDIC Usual Care
Hide Arm/Group Description

Multidisciplinary education and diabetes intervention for cardiac risk reduction

Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention

Interactive Education: interactive lectures with hands-on learning

Role modeling: learning from peers with similar disease and problems

Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms

usual care
All-Cause Mortality
MEDIC Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MEDIC Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/58 (0.00%)      1/51 (1.96%)    
Cardiac disorders     
Hospitalization  [1]  0/58 (0.00%)  0 1/51 (1.96%)  1
Indicates events were collected by systematic assessment
[1]
was admitted into the hospital for abnormal nonspecific EKG findings from 1/25/06 until 2/1/06
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MEDIC Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/58 (18.97%)      2/51 (3.92%)    
Blood and lymphatic system disorders     
hypoglycemia  [1]  0/58 (0.00%)  0 1/51 (1.96%)  1
Cardiac disorders     
Syncope  [2]  1/58 (1.72%)  1 0/51 (0.00%)  0
hypertension  [3]  1/58 (1.72%)  1 0/51 (0.00%)  0
Ear and labyrinth disorders     
Ear ache  [4]  1/58 (1.72%)  1 0/51 (0.00%)  0
Eye disorders     
Blepharitis  [5]  1/58 (1.72%)  1 0/51 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Lower Back Pain  [6]  1/58 (1.72%)  1 0/51 (0.00%)  0
Renal and urinary disorders     
hematuria  [7]  1/58 (1.72%)  1 0/51 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  [8]  1/58 (1.72%)  1 1/51 (1.96%)  1
Bronchitis  [9]  1/58 (1.72%)  1 0/51 (0.00%)  0
Skin and subcutaneous tissue disorders     
Cellulitis Abcess  [10]  1/58 (1.72%)  1 0/51 (0.00%)  0
Laceration  [11]  1/58 (1.72%)  1 0/51 (0.00%)  0
Toe infection  [12]  1/58 (1.72%)  1 0/51 (0.00%)  0
rash  [13]  1/58 (1.72%)  1 0/51 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
was seen in the emergency room on 5/29/07 for hypoglycemia
[2]
seen in the emergency room and admitted on 7/14/05 for syncope
[3]
was seen in the emergency room on 12/1/05 for hypertension
[4]
was seen in the emergency room on 1/2/06 for an ear and headache
[5]
was seen in the emergency room on 8/19/05 for blepheritis
[6]
seen in the emergency room on 7/25/05 for lower back pain
[7]
was seen in the emergency room on 2/1/06 for hematuria and abdominal pain
[8]
seen in the emergence room for cough
[9]
was seen in the emergency room, on 11/19/05 for acute bronchitis
[10]
was seen in the emergency room on 9/14/05 for cellulitis, hypertension and skin abscess.
[11]
was seen in the emergency room on 10/2/05 for a laceration
[12]
was seen in the emergency room on 11/17/05 for a toe infection
[13]
was seen in the emergency room on 2/7/06 for rash
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Wen-Chih Wu, MD; Principal Investigator
Organization: Providence VA Medical Center
Phone: 4012737100 ext 6237
Responsible Party: Wen-Chih Wu, Providence VA Medical Center
ClinicalTrials.gov Identifier: NCT00357955     History of Changes
Other Study ID Numbers: 12733
First Submitted: July 24, 2006
First Posted: July 28, 2006
Results First Submitted: January 14, 2014
Results First Posted: May 13, 2014
Last Update Posted: May 13, 2014