Improving Insulin Therapy With Enhanced Care Management

NCT ID: NCT00320112

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-03-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Reciprocal Diabetes Peer Support Program

Intervention Type: BEHAVIORAL

participants are paired with another age-matched participation. Paired peer partners were encouraged to talk weekly using a telephone platform that recorded call frequency and duration and provided automated reminders promoting peer contact.

group outpatient counseling visits

Intervention Type: BEHAVIORAL

Participants in the peer group were also offered three optional 1.5 hour patient-driven group sessions at month 1, 3, and 6

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.

Group Type: OTHER

Nurse Case management

Intervention Type: BEHAVIORAL

patients are not paired in the NCM arm attended a 1.5 hour session to receive education on care manager services and diabetes educational materials and be assigned to a nurse care manager with whom they were encouraged to follow-up regularly.

Interventions

Reciprocal Diabetes Peer Support Program

participants are paired with another age-matched participation. Paired peer partners were encouraged to talk weekly using a telephone platform that recorded call frequency and duration and provided automated reminders promoting peer contact.

Intervention Type: BEHAVIORAL

Nurse Case management

patients are not paired in the NCM arm attended a 1.5 hour session to receive education on care manager services and diabetes educational materials and be assigned to a nurse care manager with whom they were encouraged to follow-up regularly.

Intervention Type: BEHAVIORAL

group outpatient counseling visits

Participants in the peer group were also offered three optional 1.5 hour patient-driven group sessions at month 1, 3, and 6

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D. Piette, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20956707 (View on PubMed)

Other Identifiers

IIR 04-239

Identifier Type: -

Identifier Source: org_study_id