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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00700908
First received: June 17, 2008
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Type 2 Diabetes
 Behavioral: automated telephone intervention vs. usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of an Automated Telephone Intervention on HbA1c in Type 2 Diabetes: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in adherence to SMBG frequency [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: June 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Automated telephone intervention
 Behavioral: automated telephone intervention vs. usual care
Active Comparator: 2
Usual care
 Behavioral: automated telephone intervention vs. usual care

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700908

Locations
United States, Minnesota
Primary Care Center University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Novo Nordisk
Investigators
Principal Investigator: Judith Graziano, PhD, RN University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00700908     History of Changes
Other Study ID Numbers: 0701M99406
Study First Received: June 17, 2008
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
type 2 diabetes
telephone intervention
automated

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013