Trial Outcomes & Findings for Can Group Visits Improve Outcomes of Veterans With Diabetes (NCT NCT00286741)

NCT ID: NCT00286741

Last Updated: 2019-01-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 239 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-01-09

Participant Flow

Participant milestones

Measure	Medical Group Visits Medical group visits Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.	Control control
Overall Study STARTED	133	106
Overall Study COMPLETED	122	89
Overall Study NOT COMPLETED	11	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Can Group Visits Improve Outcomes of Veterans With Diabetes

Baseline characteristics by cohort

Measure	Arm 1 n=133 Participants Medical group visits Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.	Arm 2 n=106 Participants control	Total n=239 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 9.4 • n=5 Participants	60.8 years STANDARD_DEVIATION 10 • n=7 Participants	62.0 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	102 Participants n=7 Participants	229 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	72 Participants n=5 Participants	71 Participants n=7 Participants	143 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	29 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants n=5 Participants	103 Participants n=7 Participants	231 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Medical Group Visits n=133 Participants Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.	Control n=106 Participants Treatment as Usual Control
Hemoglobin A1c	8.4 percentage points Standard Deviation 1.3	8.7 percentage points Standard Deviation 1.5

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Medical Group Visits n=133 Participants Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.	Control n=106 Participants Treatment as Usual Control
Systolic Blood Pressure	140 mmHg Standard Deviation 14.8	147 mmHg Standard Deviation 13.4

SECONDARY outcome

Timeframe: one year

Population: Analysis was not performed - project staff and data no longer available.

Outcome measures

Outcome data not reported

Adverse Events

Medical Group Visits

Serious events: 59 serious events

Other events: 122 other events

Deaths: 0 deaths

Control

Serious events: 37 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Measure	Medical Group Visits n=133 participants at risk Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.	Control n=106 participants at risk Treatment as Usual Control
General disorders Death	2.3% 3/133	0.94% 1/106
General disorders All-Cause hospitalization	42.1% 56/133	34.0% 36/106

Other adverse events

Measure	Medical Group Visits n=133 participants at risk Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.	Control n=106 participants at risk Treatment as Usual Control
Endocrine disorders Hypoglycemia	75.9% 101/133	78.3% 83/106
Vascular disorders Hypotension	14.3% 19/133	13.2% 14/106
Vascular disorders Lightheadedness	49.6% 66/133	58.5% 62/106
Renal and urinary disorders Renal insufficiency	53.4% 71/133	48.1% 51/106
Hepatobiliary disorders Hepatic insufficiency	1.5% 2/133	1.9% 2/106

Additional Information

David Edelman

Durham VA Medical Center

Phone: 919-286-6936

Email: dedelman@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place