NCT00263835

Brief Summary

The purpose of this study is to modify and evaluate a culturally appropriate intervention that is designed to improve diabetes self-care practices by enhancing the self-efficacy, empowerment and diabetes knowledge among Latino adults over the age of 55 years.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2 diabetes

Timeline
Completed

Started Oct 2004

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

Study Start

First participant enrolled

October 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

First QC Date

December 7, 2005

Last Update Submit

March 1, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin A1c.

Secondary Outcomes (1)

  • Change in blood pressure, cholesterol, and weight.

Interventions

EmpowermentBEHAVIORAL

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-Identify as having diabetes, be 55 years of age or older, Latino/a and have a hemoglobing A1c of 8% or greater.

You may not qualify if:

  • Non diabetic, under 55, non Latino/a, a hemoglobin A1c of less than 8%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sugiyama T, Steers WN, Wenger NS, Duru OK, Mangione CM. Effect of a community-based diabetes self-management empowerment program on mental health-related quality of life: a causal mediation analysis from a randomized controlled trial. BMC Health Serv Res. 2015 Mar 22;15:115. doi: 10.1186/s12913-015-0779-2.

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Carol M Mangione, M.D., MSPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

December 7, 2005

First Posted

December 9, 2005

Study Start

October 1, 2004

Study Completion

May 1, 2006

Last Updated

March 2, 2010

Record last verified: 2010-03