NCT01344668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

April 27, 2011

Last Update Submit

October 12, 2016

Conditions

Type 2 Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Standard Diabetes Education

OTHER

Standard Diabetes Education

Other: Standard Diabetes Education

Enhanced Diabetes Education

OTHER

Enhanced Diabetes Education

Other: Enhanced Diabetes Education

Interventions

Enhanced Diabetes EducationOTHER

Provide enhanced diabetes education

Enhanced Diabetes Education
Standard Diabetes EducationOTHER

Provide Standard Diabetes Education

Standard Diabetes Education

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Russell L. Rothman, MD, MPP

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 29, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Locations

US(1)