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The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care (PRIDE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344668
First Posted: April 29, 2011
Last Update Posted: October 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Russell Rothman, Vanderbilt University
  Purpose
The primary hypotheses are that the intervention will improve A1C, blood pressure, lipids, weight, self-efficacy, self-management behaviors, and use of clinical services at 12 and 24 months follow-up.

Condition Intervention
Type 2 Diabetes Other: Enhanced Diabetes Education Other: Standard Diabetes Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care

Resource links provided by NLM:


Further study details as provided by Russell Rothman, Vanderbilt University:

Primary Outcome Measures:
  • Improvement in A1C at 12 months [ Time Frame: 12 months ]
    The primary outcome will be the improvement in A1C at 12 months between Intervention group patients and Control group patients.


Enrollment: 411
Study Start Date: May 2011
Study Completion Date: May 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard Diabetes Education
Standard Diabetes Education
Other: Standard Diabetes Education
Provide Standard Diabetes Education
Enhanced Diabetes Education
Enhanced Diabetes Education
Other: Enhanced Diabetes Education
Provide enhanced diabetes education

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient has a clinical diagnosis of Type 2 Diabetes
  • Age 18-85 years
  • English or Spanish speaking
  • Most recent A1C ≥ 7.5%
  • Patient agrees to participate in the study for the full two years duration.

Exclusion Criteria:

  • Poor visual acuity (vision worse than 20/50 using Rosenbaum Pocket Screener) -- Significant dementia or psychosis (by health provider report or chart review)
  • Terminal illness with anticipated life expectancy < 2 years (per health provider or patient report).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344668


Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Russell L. Rothman, MD, MPP Vanderbilt University
  More Information

Responsible Party: Russell Rothman, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01344668     History of Changes
Other Study ID Numbers: 101523
1R18DK083264-01A2 ( U.S. NIH Grant/Contract )
First Submitted: April 27, 2011
First Posted: April 29, 2011
Last Update Posted: October 14, 2016
Last Verified: October 2016

Keywords provided by Russell Rothman, Vanderbilt University:
Diabetes

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