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

NCT ID: NCT01344668

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Diabetes Education

Standard Diabetes Education

Group Type OTHER

Standard Diabetes Education

Intervention Type OTHER

Provide Standard Diabetes Education

Enhanced Diabetes Education

Enhanced Diabetes Education

Group Type OTHER

Enhanced Diabetes Education

Intervention Type OTHER

Provide enhanced diabetes education

Interventions

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Enhanced Diabetes Education

Provide enhanced diabetes education

Intervention Type OTHER

Standard Diabetes Education

Provide Standard Diabetes Education

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Russell Rothman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Russell L. Rothman, MD, MPP

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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1R18DK083264-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

101523

Identifier Type: -

Identifier Source: org_study_id

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