Clinical Trials Directory

Trials / Completed

CompletedNCT01117831

An Analysis of Diabetes Control in Puerto Rico

An Analysis of Variables That Affect Quality of Diabetes Control in Puerto Rico

Status
Completed
Phase
Study type
Observational
Enrollment
600 (actual)
Sponsor
Center for Diabetes Control, Inc. · Industry
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

Project: An analysis of Diabetes Control in Puerto Rico Hypothesis: This project seeks to determine the causes for: i) poor adherence to prescribed treatment by patients, ii) low compliance by providers with national guidelines iii) barriers impose by health insurance in control of diabetes mellitus iv) effectiveness of a disease management program for treatment adherence by patients.

Detailed description

Method (s) The study will consist of three phases: i) assessment phase, ii) multimedia health education campaign for patients, providers and local health insurances for adherence improvement iii) reassessment phase. Target Population: Phase I: 600 Hispanic, male and female, residents of Puerto Rico with a diagnosis of type 1 and 2 diabetes mellitus older than 18 of age. Phase II: 600 patients identified in phase I with individualize health education interventions on the importance of adherence to prescribed medical treatment. 2) Spanish speaking population of Puerto Rico, health service providers, and health insurance companies through a multimedia health education campaign. Phase III: reassessment of the 600 patients of Phase I. Data Collection Tools: i) Demographic information will be obtained by an interview questionnaire. Patients will be assigned a control number automatically by the data system. ii) Laboratory blood samples for A1C, lipids (total cholesterol, triglycerides and HDL cholesterol), and serum creatinine. iii) A comprehensive educational adherence program with different media strategies such as: radio spots, newspaper articles, public service announcements, telemedicine services. Data Analysis: Data will be analyzed using SPSS for Windows.

Conditions

Interventions

TypeNameDescription
OTHEREpidemiological interventionAn analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control.

Timeline

Start date
2010-03-01
Primary completion
2012-11-01
Completion
2013-02-01
First posted
2010-05-06
Last updated
2017-07-21

Source: ClinicalTrials.gov record NCT01117831. Inclusion in this directory is not an endorsement.