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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Russell Rothman, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01344668
First received: April 27, 2011
Last updated: June 20, 2013
Last verified: June 2013
  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:


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.


Enrollment: 411
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
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: NCT01344668

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Russell L. Rothman, MD, MPP Vanderbilt University
  More Information

No publications provided

Responsible Party: Russell Rothman, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01344668     History of Changes
Other Study ID Numbers: 101523, 1R18DK083264-01A2
Study First Received: April 27, 2011
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Diabetes

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

ClinicalTrials.gov processed this record on September 18, 2014