NCT00245882

Brief Summary

The purpose of this research study is to compare two different methods of helping veterans with diabetes better manage their disease. This study will compare an "Active Care Management" method using home-based technology and self-monitoring techniques with a lower-intensity "Care Coordination" method based on monthly telephone contact with a nurse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable 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

Study Start

First participant enrolled

October 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

2.2 years

First QC Date

October 27, 2005

Last Update Submit

September 17, 2012

Conditions

Diabetes

Keywords

TelehealthVeteransGlycemic controlActive care managementCare coordination

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    3 months

Secondary Outcomes (6)

  • Proportion of subjects in each cohort with HbA1c </= 7%, BP </= 130/80, LDL-cholesterol </= 100 mg/dl, and triglycerides </= 150 mg/dl at six months

    3 months, 6 months, 9 months, 12 months

  • Proxy measures for cost of care (number of outpatient clinic visits, emergency room visits, hospital bed days, and pharmacy costs)

    3 months, 6 months, 9 months, 12 months

  • For subjects not on insulin at enrollment, time to prescription of insulin

    6 months, 12 months

  • For subjects on insulin at enrollment, time to change in dose and/or type of insulin

    6 months, 12 months

  • Subject satisfaction with care

    6 months, 12 months

  • +1 more secondary outcomes

Study Arms (2)

Care Coordination

ACTIVE COMPARATOR

Care Coordination with monthly follow-up by a diabetes nurse educator

Behavioral: Care Coordination

Home Telemedicine

ACTIVE COMPARATOR

Active Care Management with Home Telemedicine

Behavioral: Home Telemedicine

Interventions

Care CoordinationBEHAVIORAL

Care coordination with monthly follow-up by a diabetes nurse educator

Also known as: Control
Care Coordination
Home TelemedicineBEHAVIORAL

Active care management by a nurse practitioner using home telemedicine

Also known as: Active Care Management
Home Telemedicine

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • enrolled for primary care at a VA Pittsburgh Healthcare System (VAPHS)site with at least one visit from June 1, 2004 through December 31, 2005
  • diagnosed with diabetes mellitus with at least 12 months of ongoing pharmacologic treatment (at least one oral hypoglycemic agent, insulin, or both)
  • born in 1926 or later
  • have an HbA1c level \>/= 8.0% at the last assessment (between 6/1/04 and 12/31/05)
  • have an HbA1c level \>/= 7.5% (by finger stick) at the time of enrollment
  • mentally competent to give informed consent

You may not qualify if:

  • one or more visits to the VAPHS Diabetes Clinic from June 1, 2004 through December 31, 2005
  • metastatic or inoperable cancer
  • Child-Pugh Class B or C end-stage liver disease
  • HIV/AIDS
  • end-stage renal disease requiring dialysis
  • ongoing home oxygen therapy
  • a history of major organ transplant (i.e., heart, lung, kidney, liver)
  • residence in an institution (e.g. nursing home, personal care home, or prison)
  • incompatible telephone service (i.e., either none or digital)
  • concurrent participation in any other research protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

  • Stone RA, Sevick MA, Rao RH, Macpherson DS, Cheng C, Kim S, Hough LJ, DeRubertis FR. The Diabetes Telemonitoring Study Extension: an exploratory randomized comparison of alternative interventions to maintain glycemic control after withdrawal of diabetes home telemonitoring. J Am Med Inform Assoc. 2012 Nov-Dec;19(6):973-9. doi: 10.1136/amiajnl-2012-000815. Epub 2012 May 19.

    PMID: 22610495DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Frederick R DeRubertis, MD

    VA Pittsburgh Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 18, 2012

Record last verified: 2012-09

Locations

US(1)