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Can Group Visits Improve Outcomes of Veterans With Diabetes

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ClinicalTrials.gov Identifier: NCT00286741
Recruitment Status : Completed
First Posted : February 3, 2006
Results First Posted : September 11, 2014
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Diabetes
Hypertension
Intervention Other: Diabetes Group Management Visits
Enrollment 239
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Medical Group Visits Control
Hide Arm/Group Description

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
Period Title: Overall Study
Started 133 106
Completed 122 89
Not Completed 11 17
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

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 Total of all reporting groups
Overall Number of Baseline Participants 133 106 239
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 106 participants 239 participants
63  (9.4) 60.8  (10) 62.0  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 106 participants 239 participants
Female
6
   4.5%
4
   3.8%
10
   4.2%
Male
127
  95.5%
102
  96.2%
229
  95.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 106 participants 239 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
72
  54.1%
71
  67.0%
143
  59.8%
White
57
  42.9%
29
  27.4%
86
  36.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.0%
6
   5.7%
10
   4.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 106 participants 239 participants
Hispanic or Latino
3
   2.3%
2
   1.9%
5
   2.1%
Not Hispanic or Latino
128
  96.2%
103
  97.2%
231
  96.7%
Unknown or Not Reported
2
   1.5%
1
   0.9%
3
   1.3%
1.Primary Outcome
Title Hemoglobin A1c
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Group Visits Control
Hide Arm/Group Description:
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.
Treatment as Usual Control
Overall Number of Participants Analyzed 133 106
Mean (Standard Deviation)
Unit of Measure: percentage points
8.4  (1.3) 8.7  (1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medical Group Visits, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Group Visits Treatment as Usual Control
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 133 106
Mean (Standard Deviation)
Unit of Measure: mmHg
140  (14.8) 147  (13.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medical Group Visits, Treatment as Usual Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Cost-effectiveness, Proportion of Patients With LDL < 100, Health Services Utilization, Quality of Life (as Measured by DQoL), Patient Empowerment (as Measured by DES).
Hide Description [Not Specified]
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed - project staff and data no longer available.
Arm/Group Title Medical Group Visits Control
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Medical Group Visits Control
Hide Arm/Group Description 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. Treatment as Usual Control
All-Cause Mortality
Medical Group Visits Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Medical Group Visits Control
Affected / at Risk (%) Affected / at Risk (%)
Total   59/133 (44.36%)   37/106 (34.91%) 
General disorders     
Death   3/133 (2.26%)  1/106 (0.94%) 
All-Cause hospitalization   56/133 (42.11%)  36/106 (33.96%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medical Group Visits Control
Affected / at Risk (%) Affected / at Risk (%)
Total   122/133 (91.73%)   85/106 (80.19%) 
Endocrine disorders     
Hypoglycemia  [1]  101/133 (75.94%)  83/106 (78.30%) 
Hepatobiliary disorders     
Hepatic insufficiency  [2]  2/133 (1.50%)  2/106 (1.89%) 
Renal and urinary disorders     
Renal insufficiency  [3]  71/133 (53.38%)  51/106 (48.11%) 
Vascular disorders     
Hypotension  [4]  19/133 (14.29%)  14/106 (13.21%) 
Lightheadedness  [5]  66/133 (49.62%)  62/106 (58.49%) 
Indicates events were collected by systematic assessment
[1]
Patient self-report, or blood glucose measured < 60
[2]
Aspartate aminotransferase or alanine aminotransferase > 50 U/liter
[3]
Decrease in estimate Glomerular Filtration Rate > 10 ml/min/1.73 m2
[4]
Systolic Blood Pressure < 100
[5]
Patient self-report
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Edelman
Organization: Durham VA Medical Center
Phone: 919-286-6936
EMail: dedelman@duke.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00286741    
Other Study ID Numbers: IIR 03-084
First Submitted: February 1, 2006
First Posted: February 3, 2006
Results First Submitted: July 31, 2014
Results First Posted: September 11, 2014
Last Update Posted: January 9, 2019