NCT00320112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

November 10, 2014

Completed
Last Updated

April 24, 2015

Status Verified

August 1, 2014

Enrollment Period

2.7 years

First QC Date

April 27, 2006

Results QC Date

September 19, 2014

Last Update Submit

April 6, 2015

Conditions

Diabetes

Keywords

telemedicinecase managementinsulinself-care

Outcome Measures

Primary Outcomes (1)

  • Change in Glycemic Control (HbA1c)

    The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer.

    6 months (baseline to 6 months)

Secondary Outcomes (3)

  • Change in Systolic Blood Pressure Measure

    change in blood pressure at 6 months

  • Change in Diastolic Blood Pressure

    6 months from baseline

  • Number of Participants With Insulin Starts at 6 Months

    6 months (baseline to 6 months follow-up)

Study Arms (2)

Reciprocal Diabetes Peer Support program

EXPERIMENTAL

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 ProgramBehavioral: group outpatient counseling visits

Nurse Case Management

OTHER

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

Interventions

Reciprocal Diabetes Peer Support ProgramBEHAVIORAL

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.

Reciprocal Diabetes Peer Support program
Nurse Case managementBEHAVIORAL

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.

Nurse Case Management
group outpatient counseling visitsBEHAVIORAL

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

Reciprocal Diabetes Peer Support program

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (1)

  • 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.

    PMID: 20956707RESULT

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

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.

Results Point of Contact

Title
Fatima Makki
Organization
VA HSRD
Fatima.Makki@va.gov
734 845 3623

Study Officials

  • John D. Piette, PhD

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2006

First Posted

May 3, 2006

Study Start

February 1, 2007

Primary Completion

October 1, 2009

Study Completion

March 1, 2010

Last Updated

April 24, 2015

Results First Posted

November 10, 2014

Record last verified: 2014-08

Locations

US(1)