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

Type 2 Diabetes Clinical Trial

— PRIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344668
• Other study ID #: 101523
• Secondary ID: 1R18DK083264-01A
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: October 12, 2016
• Start date: May 2011
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Other:
• Enhanced Diabetes Education
Provide enhanced diabetes education
• Standard Diabetes Education
Provide Standard Diabetes Education

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in A1C at 12 months	The primary outcome will be the improvement in A1C at 12 months between Intervention group patients and Control group patients.	12 months	No