The Public Private Partnership Addressing Literacy-Numera... | NCT01344668

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

NCT01344668

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Oct 14, 2016Estimated

Enrollment

411Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

Enhanced Diabetes Education
Standard Diabetes Education

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R18DK083264-01A2	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

May 2015Actual

Completion Date

May 2016Actual

First Submitted Date

Apr 27, 2011

First Submission Date that Met QC Criteria

Apr 28, 2011

First Posted Date

Apr 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 14, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Russell Rothman, Principal Investigator, Vanderbilt UniversityPrincipal Investigator

Lead Sponsor

Vanderbilt UniversityOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

411Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Diabetes Education	Other	Standard Diabetes Education	Other: Standard Diabetes Education
Enhanced Diabetes Education	Other	Enhanced Diabetes Education	Other: Enhanced Diabetes Education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enhanced Diabetes Education	Other	Provide enhanced diabetes education	Enhanced Diabetes Education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Russell L. Rothman, MD, MPP	Vanderbilt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University		Nashville	Tennessee	37232	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided