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=5 Participants	62.3 years STANDARD_DEVIATION 6.6 • n=7 Participants	62.0 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	119 Participants n=7 Participants	244 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	99 participants n=5 Participants	98 participants n=7 Participants	197 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized African American	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Other	9 participants n=5 Participants	5 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized unkwown	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Education Some High School, High School	34 participants n=5 Participants	35 participants n=7 Participants	69 participants n=5 Participants
Education at least some college, technical\vocational school	91 participants n=5 Participants	83 participants n=7 Participants	174 participants n=5 Participants
Education unknown	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Annual Income less than or equal to $30,000	78 participants n=5 Participants	71 participants n=7 Participants	149 participants n=5 Participants
Annual Income greater than or equal to $31,000	46 participants n=5 Participants	41 participants n=7 Participants	87 participants n=5 Participants
Annual Income other or unknown	1 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants
Social Support Lives with a spouse	82 participants n=5 Participants	84 participants n=7 Participants	166 participants n=5 Participants
Social Support Lives alone	29 participants n=5 Participants	22 participants n=7 Participants	51 participants n=5 Participants
Social Support Other	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants
Anti-hyperglycemic Medications Only oral diabetes medication	55 participants n=5 Participants	53 participants n=7 Participants	108 participants n=5 Participants
Anti-hyperglycemic Medications Insulin, + or - oral medication	70 participants n=5 Participants	66 participants n=7 Participants	136 participants n=5 Participants
Self-Rated General Health Status - Fair or Poor Health	59 participants n=5 Participants	64 participants n=7 Participants	123 participants n=5 Participants
HbA1c	8.02 percent HbA1c STANDARD_DEVIATION 1.32 • n=5 Participants	7.93 percent HbA1c STANDARD_DEVIATION 1.40 • n=7 Participants	7.98 percent HbA1c STANDARD_DEVIATION 1.40 • n=5 Participants
Systolic Blood Pressure	140.3 mmHg STANDARD_DEVIATION 18.6 • n=5 Participants	136.4 mmHg STANDARD_DEVIATION 16.9 • n=7 Participants	138.4 mmHg STANDARD_DEVIATION 17.9 • n=5 Participants
Diastolic Blood Pressure	77.1 mmHg STANDARD_DEVIATION 11.5 • n=5 Participants	75.8 mmHg STANDARD_DEVIATION 10.7 • n=7 Participants	76.5 mmHg STANDARD_DEVIATION 11.1 • n=5 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 months

Population: 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 baseline

Population: 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 baseline diastolic blood pressure	77.1 mmHg Standard Deviation 11.5	75.8 mmHg Standard Deviation 10.7
Change in Diastolic Blood Pressure 6 month diastolic blood pressure	76.8 mmHg Standard Deviation 11.9	76.1 mmHg Standard Deviation 10.6

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

Fatima Makki

VA HSRD

Phone: 734 845 3623

Email: Fatima.Makki@va.gov

Results disclosure agreements

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