An Analysis of Diabetes Control in Puerto Rico

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Novo Nordisk A/S
Eli Lilly and Company
Information provided by:
Center for Diabetes Control, Inc.
ClinicalTrials.gov Identifier:
NCT01117831
First received: May 4, 2010
Last updated: May 5, 2010
Last verified: May 2010
  Purpose

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.


Condition
Diabetes Mellitus
Arterial Hypertension
Hypercholesterolemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Analysis of Variables That Affect Quality of Diabetes Control in Puerto Rico

Resource links provided by NLM:


Further study details as provided by Center for Diabetes Control, Inc.:

Estimated Enrollment: 600
Study Start Date: March 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This epidemiologic study will analyzed a 600 type 1 and 2 Diabetic patients under medication. The populations to be analyzed is composed of female and male subjects under therapy with anti diabetic medication. The population will be selected from four high density cities in the Island of Puerto Rico. Puerto Ricans are considered as hispanic populations with a mix of white hispanic, african people on a basis of indians ancestry. Subjects will be invited to participate in the study.

Criteria

Inclusion Criteria:

  • Type 1 and 2 diabetic patients older tha 18 years old

Exclusion Criteria:

  • 1. Hemophilia.
  • 2. Persons younger than 18.
  • 3. Persons in research studies of some drug.
  • 4. Persons using steroids.
  • 5. Patients with acute infections.
  • 6. Pregnant diabetic patients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117831

Sponsors and Collaborators
Center for Diabetes Control, Inc.
Novo Nordisk A/S
Eli Lilly and Company
Investigators
Principal Investigator: Efrain Rodriguez-Vigil, MD Center for Diabetes Control, Inc.
  More Information

No publications provided

Responsible Party: Efrain Rodriguez-Vigil, MD, Medical Director, Center for Diabetes Control, Inc.
ClinicalTrials.gov Identifier: NCT01117831     History of Changes
Other Study ID Numbers: CD0108
Study First Received: May 4, 2010
Last Updated: May 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Center for Diabetes Control, Inc.:
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Hypercholesterolemia
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014