CClinicalTrials.gg
CompletedNCT00012753Updated Apr 7, 2015

Automated Calls With Nurse Follow-Up to Improve Diabetes Ambulatory Care

A Phase 3 interventional study of Automated telephone health status assessments with nurse follow-up. in Diabetes, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by US Department of Veterans Affairs · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
272
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Background:

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.

Objectives:

This study evaluated Automated Telephone Disease Management (ATDM) calls with telephone nurse follow-up as a means of improving the quality of VA diabetes care. Specifically, we will determine whether this service improves patients' glucose control; improves other important outcomes such as their quality of life, satisfaction with care, and health service use; improves health behaviors such as self-monitoring of blood glucose, fat intake, and medication adherence; and has effects that vary across patient subgroups.

Methods:

Patients with diabetes mellitus using hypoglycemic medication were enrolled during outpatient visits to a university-affiliated VA health care system and randomized to usual care or bi-weekly ATDM assessment and self-care education calls with follow-up by a nurse educator. The intervention process was evaluated by examining patients� patterns of ATDM use and the reliability and validity of information they provided. Telephone surveys were used to measure intervention effects at 12-months on patients� self-care, symptoms, satisfaction with care, and perceived access barriers. The impact on VA utilization was evaluated using electronic utilization databases, and glycemic control was measured using laboratory tests. A total of 292 patients were randomized and 272 (93%) provided data at 12-months. Intervention patients completed ATDM assessments consistently throughout the observation period and the assessments identified groups of intervention patients with varying degrees of health risk at baseline. Compared to control patients, intervention patients at 12-months reported more frequent glucose self-monitoring, fewer access problems, and greater satisfaction with care (all p = 0.05). Intervention patients were more likely than controls to have been seen in podiatry clinics (53% versus 31%, p = 0.003) and diabetes specialty clinics (31% versus 17%, p = 0.03) during the study. The intervention did not influence mean endpoint HgA1c levels overall. However, among patients with baseline HgA1c = 8%, mean endpoint values among intervention and control patients were 8.7% and 9.2%, respectively (p = 0.05); intervention effects were even greater among patients with baseline HgA1c = 9%. Moreover, intervention patients at follow-up reported fewer symptoms of poor glycemic control than patients receiving usual care (3.6 versus 4.4, p = 0.03).

Status:

Completed.

02

Conditions studied

  • Diabetes

Browse trials for

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 272 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
272 participants (estimated)

Study arms

  • Other
    Arm 1

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

Interventions

  • ProcedureAutomated telephone health status assessments with nurse follow-up.
06

Study locations

1 site
  • VA Palo Alto Health Care System, Palo Alto, CA
    Palo Alto, Michigan 94304-1290, United States
07

References and documents

Publications

  • 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. PubMed 10480775 ↗
  • 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. PubMed 10490057 ↗
  • 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. PubMed 11912804 ↗
  • 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. PubMed 11119172 ↗
  • 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. PubMed 11213866 ↗
  • Piette JD. Interactive voice response systems in the diagnosis and management of chronic disease. Am J Manag Care. 2000 Jul;6(7):817-27. PubMed 11067378 ↗
  • 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. PubMed 10386566 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00012753
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Mar 16, 2001
Completion
Dec 1999
Last update
Apr 7, 2015

Study contacts

John D. Piette, PhD
principal investigator · VA Palo Alto Health Care System, Palo Alto, CA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion