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Improving Insulin Therapy With Enhanced Care Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00320112
First received: April 27, 2006
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Behavioral: Reciprocal Diabetes Peer Support Program
Behavioral: Nurse Case management
Behavioral: group outpatient counseling visits
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Improving Insulin Therapy With Enhanced Care Management and Peer Support

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in Glycemic Control (HbA1c) [ Time Frame: 6 months (baseline to 6 months) ] [ Designated as safety issue: No ]
    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:
  • Change in Systolic Blood Pressure Measure [ Time Frame: change in blood pressure at 6 months ] [ Designated as safety issue: No ]
    secondary outcome measure was change in blood pressure comparison of peer support group and nurse case management group from baseline to six months

  • Change in Diastolic Blood Pressure [ Time Frame: 6 months from baseline ] [ Designated as safety issue: No ]
    change in diastolic blood pressure was measured at 6 months

  • Number of Participants With Insulin Starts at 6 Months [ Time Frame: 6 months (baseline to 6 months follow-up) ] [ Designated as safety issue: No ]
    the number of insulin starts at 6 months from baseline.


Enrollment: 244
Study Start Date: February 2007
Study Completion Date: March 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.
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
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.
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320112

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: John D. Piette, PhD VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00320112     History of Changes
Other Study ID Numbers: IIR 04-239
Study First Received: April 27, 2006
Results First Received: September 19, 2014
Last Updated: November 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
telemedicine
case management
insulin
self-care

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014