NCT00012753

Brief Summary

Regular outpatient follow-up is important for all diabetes patients, with some needing frequent attention because their health is unstable, their treatment regimen is complex, or their social supports are inadequate. However, many patients live with access barriers that limit their use of outpatient services, fail to attend outpatient appointments, and experience worse outcomes than trials of aggressive management suggest is possible. Although labor-intensive, telephone care programs are one potential strategy for bringing diabetes management services into patients� homes and improving their glycemic control. Automated telephone disease management (ATDM) systems can augment telephone care by providing frequent monitoring and health education to large patient panels while focusing clinicians� attention on individuals who need it most. Although this technology has shown some promise, it has not been rigorously evaluated, particularly in VA.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
272

participants targeted

Target at P25-P50 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

Study Completion

Last participant's last visit for all outcomes

December 1, 1999

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 14, 2001

Last Update Submit

April 6, 2015

Conditions

Diabetes

Study Arms (1)

Arm 1

OTHER
Procedure: Automated telephone health status assessments with nurse follow-up.

Interventions

Automated telephone health status assessments with nurse follow-up.PROCEDURE
Arm 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • VA patients with diabetes taking hypoglycemic medications. Patients with serious mental disorders, no touch tone telephone, or a life expectancy of \< 1 year were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, Michigan, 94304-1290, United States

Location

Related Publications (7)

  • Piette JD, McPhee SJ, Weinberger M, Mah CA, Kraemer FB. Use of automated telephone disease management calls in an ethnically diverse sample of low-income patients with diabetes. Diabetes Care. 1999 Aug;22(8):1302-9. doi: 10.2337/diacare.22.8.1302.

    PMID: 10480775RESULT

  • Piette JD. Patient education via automated calls: a study of English and Spanish speakers with diabetes. Am J Prev Med. 1999 Aug;17(2):138-41. doi: 10.1016/s0749-3797(99)00061-6.

    PMID: 10490057RESULT

  • Piette JD. Satisfaction with automated telephone disease management calls and its relationship to their use. Diabetes Educ. 2000 Nov-Dec;26(6):1003-10. doi: 10.1177/014572170002600613.

    PMID: 11912804RESULT

  • Piette JD. Perceived access problems among patients with diabetes in two public systems of care. J Gen Intern Med. 2000 Nov;15(11):797-804. doi: 10.1046/j.1525-1497.2000.91107.x.

    PMID: 11119172RESULT

  • Piette JD, Weinberger M, Kraemer FB, McPhee SJ. Impact of automated calls with nurse follow-up on diabetes treatment outcomes in a Department of Veterans Affairs Health Care System: a randomized controlled trial. Diabetes Care. 2001 Feb;24(2):202-8. doi: 10.2337/diacare.24.2.202.

    PMID: 11213866RESULT

  • Piette JD. Interactive voice response systems in the diagnosis and management of chronic disease. Am J Manag Care. 2000 Jul;6(7):817-27.

    PMID: 11067378RESULT

  • Piette JD. Satisfaction with care among patients with diabetes in two public health care systems. Med Care. 1999 Jun;37(6):538-46. doi: 10.1097/00005650-199906000-00003.

    PMID: 10386566RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • John D. Piette, PhD

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Completion

December 1, 1999

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(1)