NCT00105898

Brief Summary

This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable diabetes-mellitus

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

February 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 7, 2015

Status Verified

August 1, 2010

Enrollment Period

2.2 years

First QC Date

March 17, 2005

Last Update Submit

April 6, 2015

Conditions

Diabetes MellitusHypertension

Keywords

Diabetes mellitusHypertensionTelemedicineCase management

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c at 12 months

    12 months

Secondary Outcomes (1)

  • Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions.

    12 months

Study Arms (3)

Arm 1

EXPERIMENTAL

Intervention group

Procedure: Web-based care management

Arm 2

ACTIVE COMPARATOR

Comparator

Procedure: Telephone and face-to-face care management

Arm 3

SHAM COMPARATOR

Comparator

Procedure: Internet access alone

Interventions

Web-based care managementPROCEDURE

Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters

Arm 1
Telephone and face-to-face care managementPROCEDURE

Participants interact with a care manager via face-to-face and telephone contact

Arm 2
Internet access alonePROCEDURE

Participants are given internet access and encouraged to seek diabetes information to help in their self management

Arm 3

Eligibility Criteria

Age25 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of diabetes mellitus
  • Age 25-79 years
  • HbA1c \>=8.5%
  • Ability to speak and understand English
  • Telephone access
  • VA-based primary care provider
  • Interest in using a glucose and BP monitor and notebook computer

You may not qualify if:

  • Visual impairment that affects ability to read

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Brockton Campus, Brockton, MA

Brockton, Massachusetts, 02301, United States

Location

Related Publications (3)

  • Conlin PR. Genes and environment in blood pressure control--salt intake again shows its importance. Am J Clin Nutr. 2008 Aug;88(2):255-6. doi: 10.1093/ajcn/88.2.255. No abstract available.

    PMID: 18689358RESULT

  • Kerfoot BP, Conlin PR, Travison T, McMahon GT. Patient safety knowledge and its determinants in medical trainees. J Gen Intern Med. 2007 Aug;22(8):1150-4. doi: 10.1007/s11606-007-0247-8. Epub 2007 Jun 6.

    PMID: 17551796RESULT

  • McMahon GT, Fonda SJ, Gomes HE, Alexis G, Conlin PR. A randomized comparison of online- and telephone-based care management with internet training alone in adult patients with poorly controlled type 2 diabetes. Diabetes Technol Ther. 2012 Nov;14(11):1060-7. doi: 10.1089/dia.2012.0137. Epub 2012 Sep 6.

    PMID: 22953754DERIVED

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Paul R. Conlin, MD

    VA Boston Healthcare System Brockton Campus, Brockton, MA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 17, 2005

First Posted

March 18, 2005

Study Start

February 1, 2005

Primary Completion

April 1, 2007

Study Completion

June 1, 2010

Last Updated

April 7, 2015

Record last verified: 2010-08

Locations

US(1)