Trial Outcomes & Findings for Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients (NCT NCT00357955)

Last Updated: 2024-11-07

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

118 participants

Primary outcome timeframe

4 months

Results posted on

2024-11-07

Participant Flow

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.

Once eligibility confirmed and consent signed, participants were randomized. There were no wash-out or run-in period.

Participant milestones

Participant milestones
Measure	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	Usual Care usual care
Overall Study STARTED	64	54
Overall Study COMPLETED	58	51
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MEDIC n=58 Participants 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 n=51 Participants usual care	Total n=109 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	20 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	31 Participants n=7 Participants	50 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 10.3 • n=5 Participants	66.8 years STANDARD_DEVIATION 10.2 • n=7 Participants	64.4 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	51 Participants n=7 Participants	104 Participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants	51 participants n=7 Participants	109 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	MEDIC n=58 Participants 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 n=51 Participants 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
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	21.6 percentage
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	39.9 percentage
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	68.6 percentage
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	77.5 percentage

Adverse Events

MEDIC

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Usual Care

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MEDIC n=58 participants at risk 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 n=51 participants at risk usual care
Cardiac disorders Hospitalization	0.00% 0/58 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	2.0% 1/51 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.

Other adverse events

Other adverse events
Measure	MEDIC n=58 participants at risk 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 n=51 participants at risk usual care
Musculoskeletal and connective tissue disorders Lower Back Pain	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Cardiac disorders Syncope	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Respiratory, thoracic and mediastinal disorders Cough	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	2.0% 1/51 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Skin and subcutaneous tissue disorders Cellulitis Abcess	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Skin and subcutaneous tissue disorders Laceration	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Eye disorders Blepharitis	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Skin and subcutaneous tissue disorders Toe infection	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Ear and labyrinth disorders Ear ache	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Respiratory, thoracic and mediastinal disorders Bronchitis	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Cardiac disorders hypertension	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Renal and urinary disorders hematuria	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Skin and subcutaneous tissue disorders rash	1.7% 1/58 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	0.00% 0/51 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.
Blood and lymphatic system disorders hypoglycemia	0.00% 0/58 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.	2.0% 1/51 • Number of events 1 • Adverse events were documented and reported for the complete study duration of 4 months and 1 month post completion of the study.

Additional Information

Wen-Chih Wu, MD; Principal Investigator

Providence VA Medical Center

Phone: 4012737100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place