Trial Outcomes & Findings for Improving Insulin Therapy With Enhanced Care Management (NCT NCT00320112)
NCT ID: NCT00320112
Last Updated: 2015-04-24
Results Overview
The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
244 participants
Primary outcome timeframe
6 months (baseline to 6 months)
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
Reciprocal Diabetes Peer Support Program (RPS)
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
119
|
|
Overall Study
COMPLETED
|
117
|
114
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Reciprocal Diabetes Peer Support Program (RPS)
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
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Death
|
2
|
1
|
Baseline Characteristics
Improving Insulin Therapy With Enhanced Care Management
Baseline characteristics by cohort
| Measure |
Receiprocal Peer Support
n=125 Participants
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
n=119 Participants
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
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 6.1 • n=99 Participants
|
62.3 years
STANDARD_DEVIATION 6.6 • n=107 Participants
|
62.0 years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
244 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
99 participants
n=99 Participants
|
98 participants
n=107 Participants
|
197 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 participants
n=99 Participants
|
5 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
unkwown
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Education
Some High School, High School
|
34 participants
n=99 Participants
|
35 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
Education
at least some college, technical\vocational school
|
91 participants
n=99 Participants
|
83 participants
n=107 Participants
|
174 participants
n=206 Participants
|
|
Education
unknown
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Annual Income
less than or equal to $30,000
|
78 participants
n=99 Participants
|
71 participants
n=107 Participants
|
149 participants
n=206 Participants
|
|
Annual Income
greater than or equal to $31,000
|
46 participants
n=99 Participants
|
41 participants
n=107 Participants
|
87 participants
n=206 Participants
|
|
Annual Income
other or unknown
|
1 participants
n=99 Participants
|
7 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Social Support
Lives with a spouse
|
82 participants
n=99 Participants
|
84 participants
n=107 Participants
|
166 participants
n=206 Participants
|
|
Social Support
Lives alone
|
29 participants
n=99 Participants
|
22 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Social Support
Other
|
14 participants
n=99 Participants
|
13 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Anti-hyperglycemic Medications
Only oral diabetes medication
|
55 participants
n=99 Participants
|
53 participants
n=107 Participants
|
108 participants
n=206 Participants
|
|
Anti-hyperglycemic Medications
Insulin, + or - oral medication
|
70 participants
n=99 Participants
|
66 participants
n=107 Participants
|
136 participants
n=206 Participants
|
|
Self-Rated General Health Status - Fair or Poor Health
|
59 participants
n=99 Participants
|
64 participants
n=107 Participants
|
123 participants
n=206 Participants
|
|
HbA1c
|
8.02 percent HbA1c
STANDARD_DEVIATION 1.32 • n=99 Participants
|
7.93 percent HbA1c
STANDARD_DEVIATION 1.40 • n=107 Participants
|
7.98 percent HbA1c
STANDARD_DEVIATION 1.40 • n=206 Participants
|
|
Systolic Blood Pressure
|
140.3 mmHg
STANDARD_DEVIATION 18.6 • n=99 Participants
|
136.4 mmHg
STANDARD_DEVIATION 16.9 • n=107 Participants
|
138.4 mmHg
STANDARD_DEVIATION 17.9 • n=206 Participants
|
|
Diastolic Blood Pressure
|
77.1 mmHg
STANDARD_DEVIATION 11.5 • n=99 Participants
|
75.8 mmHg
STANDARD_DEVIATION 10.7 • n=107 Participants
|
76.5 mmHg
STANDARD_DEVIATION 11.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months (baseline to 6 months)Population: 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.
The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer.
Outcome measures
| Measure |
Reciprocal Peer Support Group
n=113 Participants
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
n=103 Participants
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.
|
|---|---|---|
|
Change in Glycemic Control (HbA1c)
Baseline percent A1c
|
8.02 percent HbA1c
Standard Deviation 1.32
|
7.93 percent HbA1c
Standard Deviation 1.40
|
|
Change in Glycemic Control (HbA1c)
6 month percent A1c
|
7.73 percent HbA1c
Standard Deviation 1.32
|
8.22 percent HbA1c
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: change in blood pressure at 6 monthsPopulation: 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.
secondary outcome measure was change in blood pressure comparison of peer support group and nurse case management group from baseline to six months
Outcome measures
| Measure |
Reciprocal Peer Support Group
n=113 Participants
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
n=103 Participants
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.
|
|---|---|---|
|
Change in Systolic Blood Pressure Measure
baseline systolic blood pressure
|
140.3 mmHg
Standard Deviation 18.6
|
136.4 mmHg
Standard Deviation 16.9
|
|
Change in Systolic Blood Pressure Measure
6 month systolic blood pressure
|
136.9 mmHg
Standard Deviation 16.8
|
135.0 mmHg
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: 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.
change in diastolic blood pressure was measured at 6 months
Outcome measures
| Measure |
Reciprocal Peer Support Group
n=113 Participants
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
n=103 Participants
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.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
6 month diastolic blood pressure
|
76.8 mmHg
Standard Deviation 11.9
|
76.1 mmHg
Standard Deviation 10.6
|
|
Change in Diastolic Blood Pressure
baseline diastolic blood pressure
|
77.1 mmHg
Standard Deviation 11.5
|
75.8 mmHg
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: 6 months (baseline to 6 months follow-up)Population: medical charts were reviewed to obtain this information and all participant charts were reviewed
the number of insulin starts at 6 months from baseline.
Outcome measures
| Measure |
Reciprocal Peer Support Group
n=125 Participants
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
n=119 Participants
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.
|
|---|---|---|
|
Number of Participants With Insulin Starts at 6 Months
|
8 participants
|
1 participants
|
Adverse Events
Reciprocal Peer Support Intervention
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Nurse Case Management Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reciprocal Peer Support Intervention
n=125 participants at risk
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 Intervention
n=119 participants at risk
participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
|
|---|---|---|
|
General disorders
Death
|
1.6%
2/125 • Number of events 2 • adverse event information was collected through-out the course of a participants enrollment in the study - 6 months
|
0.84%
1/119 • Number of events 1 • adverse event information was collected through-out the course of a participants enrollment in the study - 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place