Impact of an Automated Telephone Intervention on Glycosylated Hemoglobin (HbA1c) in Type 2 Diabetes

February 20, 2013 updated by: University of Minnesota

The Impact of an Automated Telephone Intervention on HbA1c in Type 2 Diabetes: A Randomized Controlled Trial

Aim 1. Determine the impact of a daily, automated telephone intervention on HbA1c levels compared to standard care in older patients with type 2 diabetes.

Aim 2. Determine the impact of the automated telephone intervention compared to standard care on adherence to prescribed SMBG frequency in older patients with type 2 diabetes.

Aim 3. Determine the impact of the automated telephone intervention compared to standard care on self-reported diabetic control problems in older patients with type 2 diabetes.

Aim 4. Determine the impact of the automated telephone intervention compared to standard care on self-reported attitudes and health beliefs concerning diabetes in older patients with type 2 diabetes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Primary Care Center University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater or equal to 55
  • Type 2 diabetes
  • English speaking
  • Ability to use glucose meter

Exclusion Criteria:

  • Unable to give informed consent
  • Unwilling to allow SMBG levels to be shard with primary care physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Automated telephone intervention
Behavioral: automated telephone intervention vs. usual care
Active Comparator: 2
Usual care
Behavioral: automated telephone intervention vs. usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in adherence to SMBG frequency
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: Judith Graziano, PhD, RN, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

February 22, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0701M99406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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