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

This study is not yet open for participant recruitment.
Verified April 2011 by Vanderbilt University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01344668
First received: April 27, 2011
Last updated: April 28, 2011
Last verified: April 2011
History of Changes
  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 Blind (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:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Improvement in A1C at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary outcome will be the improvement in A1C at 12 months between Intervention group patients and Control group patients.


Estimated Enrollment: 400
Study Start Date: May 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344668

Contacts
Contact: Shari Barto, M.B.A. 615-936-2474 shari.barto@vanderbilt.edu
Contact: Matt Kennon, BA 615-936-7280 matthew.kennon@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Shari Barto, M.B.A.     615-936-2474     shari.barto@vanderbilt.edu    
Principal Investigator: Russell Rothman, MD, MPP            
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

No publications provided

Responsible Party: Russell Rothman, MD, MPP, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01344668     History of Changes
Other Study ID Numbers: 101523, 1R18DK083264-01A2
Study First Received: April 27, 2011
Last Updated: April 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Diabetes

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 19, 2013