Improving Insulin Therapy With Enhanced Care Management

• 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: US Department of Veterans Affairs
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Reciprocal Diabetes Peer Support Program (RPS)	Nurse Case Management
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

Baseline Characteristics

Arm/Group Title		Receiprocal Peer Support	Nurse Case Management	Total
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
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)

Outcome Measures

1. Primary Outcome

Title	Change in Glycemic Control (HbA1c)
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)

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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)

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
Description	change in diastolic blood pressure was measured at 6 months
Time Frame	6 months from baseline

Outcome Measure Data

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
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)

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
Description	the number of insulin starts at 6 months from baseline.
Time Frame	6 months (baseline to 6 months follow-up)

Outcome Measure Data

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
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

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]

Adverse Events

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
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	--/--		--/--
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
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%)

Limitations and Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Fatima Makki
• Organization: VA HSRD
• Phone: 734 845 3623
• EMail: Fatima.Makki@va.gov

Publications of Results:

Heisler M, Vijan S, Makki F, Piette JD. Diabetes control with reciprocal peer support versus nurse care management: a randomized trial. Ann Intern Med. 2010 Oct 19;153(8):507-15. doi: 10.7326/0003-4819-153-8-201010190-00007.

• 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