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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 A/S
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014