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Improving Insulin Therapy With Enhanced Care Management

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ClinicalTrials.gov Identifier: NCT00320112
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : November 10, 2014
Last Update Posted : April 24, 2015
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: None (Open Label)
Condition Diabetes
Interventions Behavioral: Reciprocal Diabetes Peer Support Program
Behavioral: Nurse Case management
Behavioral: group outpatient counseling visits
Enrollment 244
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Reciprocal Diabetes Peer Support Program (RPS) Nurse Case Management
Hide Arm/Group Description

participants in the intervention arm are paired with a peer

Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.

group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes.

participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts. particpants were also provided information about nurse case managements services and encouraged to use the service regularly.
Period Title: Overall Study
Started 125 119
Completed 117 114
Not Completed 8 5
Reason Not Completed
Lost to Follow-up             3             4
Withdrawal by Subject             3             0
Death             2             1
Arm/Group Title Receiprocal Peer Support Nurse Case Management Total
Hide Arm/Group Description

participants in the intervention arm are paired with a peer

Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.

group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes.

participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts Total of all reporting groups
Overall Number of Baseline Participants 125 119 244
Hide Baseline Analysis Population Description
125 participants were randomized to Reciprocal Peer Support (RPS), and 119 to Nurse case management (NCM).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 119 participants 244 participants
61.8  (6.1) 62.3  (6.6) 62.0  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 119 participants 244 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
125
 100.0%
119
 100.0%
244
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 119 participants 244 participants
White, non-Hispanic 99 98 197
Hispanic 5 2 7
African American 11 11 22
Other 9 5 14
unkwown 1 3 4
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 119 participants 244 participants
Some High School, High School 34 35 69
at least some college, technical\vocational school 91 83 174
unknown 0 1 1
Annual Income  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 119 participants 244 participants
less than or equal to $30,000 78 71 149
greater than or equal to $31,000 46 41 87
other or unknown 1 7 8
Social Support  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 119 participants 244 participants
Lives with a spouse 82 84 166
Lives alone 29 22 51
Other 14 13 27
Anti-hyperglycemic Medications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 119 participants 244 participants
Only oral diabetes medication 55 53 108
Insulin, + or - oral medication 70 66 136
Self-Rated General Health Status - Fair or Poor Health  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 119 participants 244 participants
59 64 123
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percent HbA1c
Number Analyzed 125 participants 119 participants 244 participants
8.02  (1.32) 7.93  (1.40) 7.98  (1.40)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 125 participants 119 participants 244 participants
140.3  (18.6) 136.4  (16.9) 138.4  (17.9)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 125 participants 119 participants 244 participants
77.1  (11.5) 75.8  (10.7) 76.5  (11.1)
1.Primary Outcome
Title Change in Glycemic Control (HbA1c)
Hide Description The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer.
Time Frame 6 months (baseline to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Peer Support group: 117 of the 125 provided 6 month data and 113 provided physiologic measures. Nurse Case management participants: 114 of 119 provided 6 month data and 103 provided follow-up physiologic measures.
Arm/Group Title Reciprocal Peer Support Group Nurse Case Management Group
Hide Arm/Group Description:

participants in the intervention arm are paired with a peer

Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.

group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes.

Nurse Case Management group was offered an educational session with nurse case managers on diabetes and informed of case management services. they were encouraged to utilize this service regularly.
Overall Number of Participants Analyzed 113 103
Mean (Standard Deviation)
Unit of Measure: percent HbA1c
Baseline percent A1c 8.02  (1.32) 7.93  (1.40)
6 month percent A1c 7.73  (1.32) 8.22  (1.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reciprocal Peer Support Group, Nurse Case Management Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments no differences between arms in baseline characteristics at <0.1 level, further analyses adjusted for variables that could influence the outcome like insulin use, age, commodities. because no differences in results, unadjusted analyses are reported.
Method Regression, Linear
Comments we used STATA 11's xtmixed command, which fits multi-level mixed-effects linear regression models, with clustering by assigned pairs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.58
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Systolic Blood Pressure Measure
Hide Description secondary outcome measure was change in blood pressure comparison of peer support group and nurse case management group from baseline to six months
Time Frame change in blood pressure at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
comparison of blood pressure measure taken at baseline and then again at 6 months among the two groups. as noted, 113 peer support participants provided physiologic measures at 6 months and 103 of 119 from the nurse management group provided physiologic measures at 6 months.
Arm/Group Title Change in Systolic BP at 6 Months for Peer Support Group Change in Systsolic at 6 Months for Nurse Mgt Group
Hide Arm/Group Description:
change in systolic blood pressure from baseline to six months among participants in the peer support group
change in systolic blood pressure from baseline to six months in the nurse case management group
Overall Number of Participants Analyzed 113 103
Mean (Standard Deviation)
Unit of Measure: mmHg
baseline systolic blood pressure 140.3  (18.6) 136.4  (16.9)
6 month systolic blood pressure 136.9  (16.8) 135.0  (17.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Change in Systolic BP at 6 Months for Peer Support Group, Change in Systsolic at 6 Months for Nurse Mgt Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .91
Comments this is a priori design
Method Regression, Linear
Comments [Not Specified]
3.Secondary Outcome
Title Change in Diastolic Blood Pressure
Hide Description change in diastolic blood pressure was measured at 6 months
Time Frame 6 months from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
As noted earlier, for physiologic measures only 113 of the 125 peer support participants were able to provide 6 month follow-up data and 103 of 119 nurse management group provided 6 month follow-up data.
Arm/Group Title Reciprocal Peer Support Group Nurse Case Management Group
Hide Arm/Group Description:
participants are age-matched with a peer and asked to talk with each other weekly using a telephone support sytem
participants in the nurse case management group receive initial educational session on diabetes and information bout case management services. they are encouraged to contact their nurse case manager regularly.
Overall Number of Participants Analyzed 113 103
Mean (Standard Deviation)
Unit of Measure: mmHg
baseline diastolic blood pressure 77.1  (11.5) 75.8  (10.7)
6 month diastolic blood pressure 76.8  (11.9) 76.1  (10.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reciprocal Peer Support Group, Nurse Case Management Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Insulin Starts at 6 Months
Hide Description the number of insulin starts at 6 months from baseline.
Time Frame 6 months (baseline to 6 months follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
medical charts were reviewed to obtain this information and all participant charts were reviewed
Arm/Group Title Reciprocal Peer Support Group Nurse Case Management Grouop
Hide Arm/Group Description:
patients were age-matched and assigned to a peer. they were asked to make weekly calls using a telephone support system to check in and discuss their diabetes
patients were provided an educational session and discussed nurse case management services. participants were encouraged to meet wit their case manager regularly.
Overall Number of Participants Analyzed 125 119
Measure Type: Number
Unit of Measure: participants
8 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reciprocal Peer Support Group, Nurse Case Management Grouop
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Time Frame adverse event information was collected through-out the course of a participants enrollment in the study - 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reciprocal Peer Support Intervention Nurse Case Management Intervention
Hide Arm/Group Description

participants in the intervention arm are paired with a peer

Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.

group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes.

participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
All-Cause Mortality
Reciprocal Peer Support Intervention Nurse Case Management Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Reciprocal Peer Support Intervention Nurse Case Management Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/125 (1.60%)      1/119 (0.84%)    
General disorders     
Death  1 [1]  2/125 (1.60%)  2 1/119 (0.84%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, death
[1]
Cause of death was unknown to study team
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Reciprocal Peer Support Intervention Nurse Case Management Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/125 (0.00%)      0/119 (0.00%)    
  1. study only included male patients.
  2. intervention only lasted six months.
  3. the nature of the intervention prevented blinding to treatment group.
  4. A final limitation is the relatively low rate of uptake of the intervention.
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: Fatima Makki
Organization: VA HSRD
Phone: 734 845 3623
EMail: Fatima.Makki@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00320112    
Other Study ID Numbers: IIR 04-239
First Submitted: April 27, 2006
First Posted: May 3, 2006
Results First Submitted: September 19, 2014
Results First Posted: November 10, 2014
Last Update Posted: April 24, 2015