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Improving Insulin Therapy With Enhanced Care Management

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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:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date  ICMJE April 27, 2006
First Posted Date  ICMJE May 3, 2006
Results First Submitted Date  ICMJE September 19, 2014
Results First Posted Date  ICMJE November 10, 2014
Last Update Posted Date April 24, 2015
Study Start Date  ICMJE February 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2014)
Change in Glycemic Control (HbA1c) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2006)
glycemic control (HbA1c)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2014)
  • Change in Systolic Blood Pressure Measure [ Time Frame: 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
  • Change in Diastolic Blood Pressure [ Time Frame: 6 months from baseline ]
    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) ]
    the number of insulin starts at 6 months from baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2006)
blood pressure, self-management behavior, perceived social support
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Insulin Therapy With Enhanced Care Management
Official Title  ICMJE Improving Insulin Therapy With Enhanced Care Management and Peer Support
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Diabetes
Intervention  ICMJE
  • 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: 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.
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Reciprocal Diabetes Peer Support Program
    • Behavioral: group outpatient counseling visits
  • 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.
    Intervention: Behavioral: Nurse Case management
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2014)
244
Original Enrollment  ICMJE
 (submitted: April 27, 2006)
324
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • substance abuse disorder
  • serious psychiatric illness
  • serious hearing loss
  • life expectancy < 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00320112
Other Study ID Numbers  ICMJE IIR 04-239
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE US Department of Veterans Affairs
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John D. Piette, PhD VA Ann Arbor Healthcare System, Ann Arbor, MI
PRS Account VA Office of Research and Development
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP