NCT00286741

Brief Summary

Background: Diabetes is a common, morbid and expensive disease among veterans. Achieving adequate glycemic control and blood pressure control can reduce the devastating complications of diabetes. Because the majority of patients do not achieve adequate control of blood sugar and blood pressure, innovative strategies to improve control are needed. One strategy with great potential for veterans receiving VA care is the group clinic. Group clinics have been developed over the last 5-10 years, and have been shown to improve clinical outcomes and reduce outpatient utilization in geriatric settings. Group medical clinics involve a cohort of 8-20 patients who have 1-2 hour group visits. These clinics are distinguished from traditional group education visits for diabetes by the fact that these visits involve one physician and one or more additional health care professionals, usually a nurse practitioner and/or a pharmacist, and are designed to make management changes for a number of people with the same disease in a short period of time. The effect of group medical clinics on blood sugar, blood pressure, and the cost of diabetes care, is unknown. Objectives: Our primary objectives in this project are to determine the effectiveness and cost-effectiveness of a group visit intervention in improving rates of control of diabetes and high blood pressure in patients with both illnesses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
239

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_3 diabetes

Geographic Reach
1 country

2 active sites

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

February 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

September 11, 2014

Completed
Last Updated

January 9, 2019

Status Verified

December 1, 2018

Enrollment Period

2.3 years

First QC Date

February 1, 2006

Results QC Date

July 31, 2014

Last Update Submit

December 20, 2018

Conditions

DiabetesHypertension

Keywords

DiabetesHypertensionRandomized controlled trialscost-effectivenesshealth services

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin A1c

    12 months

  • Systolic Blood Pressure

    12 months

Secondary Outcomes (1)

  • Cost-effectiveness, Proportion of Patients With LDL < 100, Health Services Utilization, Quality of Life (as Measured by DQoL), Patient Empowerment (as Measured by DES).

    one year

Study Arms (2)

Medical group visits

EXPERIMENTAL

Medical group visits

Other: Diabetes Group Management Visits

Treatment as Usual control

NO INTERVENTION

control

Interventions

Diabetes Group Management VisitsOTHER

Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.

Medical group visits

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary care at one of two participating sites,
  • HbA1c \>= 7.5%, Systolic BP \> 140 OR Diastolic BP \> 90 on 2 consecutive measurements

You may not qualify if:

  • Primary care provider excludes patient from study, -Patient states that primary care is shared with non-VA primary care provider, -New enrollment in endocrine clinic within the last 6 months, -Patient is reluctant to participate in group visit for any reason, -Reduced life expectancy, as determined by any of the following: -New York Heart Association Class IV congestive heart failure, -Lung disease requiring supplemental oxygen, -End-stage renal disease on dialysis, -Current malignancy with any evidence of disease or currently undergoing chemotherapy or radiation therapy, -Cirrhosis of the liver, or -AIDS (HIV disease does not exclude a patient in the absence of an AIDS diagnosis), -Five or more errors on Short Portable Mental Status Questionnaire, Psychotic illness with hospitalization within three years prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

Related Publications (5)

  • Edelman D, Fredrickson SK, Melnyk SD, Coffman CJ, Jeffreys AS, Datta S, Jackson GL, Harris AC, Hamilton NS, Stewart H, Stein J, Weinberger M. Medical clinics versus usual care for patients with both diabetes and hypertension: a randomized trial. Ann Intern Med. 2010 Jun 1;152(11):689-96. doi: 10.7326/0003-4819-152-11-201006010-00001.

    PMID: 20513826RESULT

  • Crowley MJ, Melnyk SD, Ostroff JL, Fredrickson SK, Jeffreys AS, Coffman CJ, Edelman D. Can group medical clinics improve lipid management in diabetes? Am J Med. 2014 Feb;127(2):145-51. doi: 10.1016/j.amjmed.2013.09.027. Epub 2013 Oct 15.

    PMID: 24462012RESULT

  • Jackson GL, Edelman D, Olsen MK, Smith VA, Maciejewski ML. Benefits of participation in diabetes group visits after trial completion. JAMA Intern Med. 2013 Apr 8;173(7):590-2. doi: 10.1001/jamainternmed.2013.2803. No abstract available.

    PMID: 23478796RESULT

  • Crowley MJ, Melnyk SD, Coffman CJ, Jeffreys AS, Edelman D. Impact of baseline insulin regimen on glycemic response to a group medical clinic intervention. Diabetes Care. 2013 Jul;36(7):1954-60. doi: 10.2337/dc12-1905. Epub 2013 Feb 7.

    PMID: 23393214RESULT

  • Edelman D, Dolor RJ, Coffman CJ, Pereira KC, Granger BB, Lindquist JH, Neary AM, Harris AJ, Bosworth HB. Nurse-led behavioral management of diabetes and hypertension in community practices: a randomized trial. J Gen Intern Med. 2015 May;30(5):626-33. doi: 10.1007/s11606-014-3154-9. Epub 2015 Jan 8.

    PMID: 25567758RESULT

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
David Edelman
Organization
Durham VA Medical Center
dedelman@duke.edu
919-286-6936

Study Officials

  • David Edelman, MD MHS

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 3, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2008

Study Completion

January 1, 2009

Last Updated

January 9, 2019

Results First Posted

September 11, 2014

Record last verified: 2018-12

Locations

US(2)