Improving Insulin Therapy With Enhanced Care Management

Phase 3

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Reciprocal Diabetes Peer Support Program; Behavioral: Nurse Case management; Behavioral: group outpatient counseling visits

• Registration Number: NCT00320112
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

VA diabetes patients often have difficulty managing their self-care and accessing clinic-based services; many also lack social support to help them meet the demands of their illness. Enhanced support is especially important when undertaking and sustaining new challenging self-care tasks, such as initiating or intensifying insulin treatment regimens. Although some VAs have implemented telephone nurse care management programs supported by automated calling services, many are reluctant to adopt these models due to nursing shortages.

Detailed Description

Background:

VA diabetes patients often have difficulty managing their self-care and accessing clinic-based services; many also lack social support to help them meet the demands of their illness. Enhanced support is especially important when undertaking and sustaining new challenging self-care tasks, such as initiating or intensifying insulin treatment regimens. Although some VAs have implemented telephone nurse care management programs supported by automated calling services, many are reluctant to adopt these models due to nursing shortages.

Objectives:

This randomized trial will evaluate an intervention using a low-cost interactive voice response (IVR) exchange system to promote peer-to-peer communication among diabetes patients initiating or increasing insulin therapy under medical guidance. The intervention is based on research demonstrating the positive impact of peer support on chronic disease outcomes and self-care behaviors, our own prior studies demonstrating the effectiveness of IVR-based self-management supports for VA diabetes patients, and a successful pilot study demonstrating VA diabetes patients' willingness to participate in IVR-facilitated peer support. The Specific Aims are: (1) To evaluate the effect of IVR-facilitated peer support on diabetes patients' glycemic control (including their A1c levels, insulin doses, hypo- and hyperglycemic symptoms) and use of VA care; (2) To assess the impact of IVR-facilitated peer support on patient-centered outcomes, including patients' satisfaction with care, perceived social support, diabetes-specific quality of life, and self-care behaviors; and (3) To identify patient characteristics associated with participation and use of IVR peer support, and mediators of the intervention's impact on patient outcomes.

Methods:

324 diabetes patients with inadequate glycemic control who are candidates for insulin initiation or intensification will be recruited from 2 VA facilities (Ann Arbor, and Toledo). We will pair eligible patients based on age, gender, and whether they are initiating or increasing insulin. Pairs will be randomized to either: 1) usual care; or 2) usual care in conjunction with the IVR-based peer support program. After their orientation, intervention participants will be asked to communicate weekly with their partner using the IVR exchange. The IVR service is designed to allow patients to communicate without divulging their home phone number, experiencing toll charges, or being responsible for insuring that contacts occur without the assistance of reminder prompts. Intervention patients who have achieved adequate glycemic control at their 6-month follow up will be encouraged to select a new treatment goal. Patients will continue to participate in weekly IVR calls for 6 months. Research staff will monitor the process via the Internet, and outcomes will be measured at six months. The primary endpoint will be HbA1c levels at 6 and 12-months. Secondary endpoints include other physiological measures and patient-centered outcomes. The intervention is designed to interact with standard outpatient VA staffing models. We will develop detailed training materials that facilitate implementation in other facilities and work with clinical managers to facilitate roll-out if the intervention is found to be effective.

Status:

Recruitment of participants is complete as well as most preliminary data analyses. 12 month data is now being analyzed.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-04-27
• Study First Submitted QC: 2006-04-27
• Study First Posted: 2006-05-03
• Study Start: 2007-02
• Primary Completion: 2009-10
• Study Completion: 2010-03
• Status Verified: 2014-08
• Results First Submitted: 2014-09-19
• Results First Submitted QC: 2014-11-06
• Results First Posted: 2014-11-10
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

• type 2 diabetes
• HbA1c > 7%
• age > 21

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Exclusion Criteria

• substance abuse disorder
• serious psychiatric illness
• serious hearing loss
• life expectancy < 12 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reciprocal Diabetes Peer Support program	group outpatient counseling visits	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.
Reciprocal Diabetes Peer Support program	Reciprocal Diabetes Peer Support Program	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.
Nurse Case Management	Nurse Case management	patients are not paired in the NCM arm. they are provided with educational session on diabetes management and informed of case management services.

Primary Outcome Measures

Name	Time	Method
Change in Glycemic Control (HbA1c)	6 months (baseline to 6 months)	The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer.

Secondary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure Measure	change in blood pressure 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
Number of Participants With Insulin Starts at 6 Months	6 months (baseline to 6 months follow-up)	the number of insulin starts at 6 months from baseline.
Change in Diastolic Blood Pressure	6 months from baseline	change in diastolic blood pressure was measured at 6 months

Trial Locations

Locations (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI; 🇺🇸 Ann Arbor, Michigan, United States