An Analysis of Diabetes Control in Puerto Rico

NCT ID: NCT01117831

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-02-28

Brief 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

Diabetes Mellitus; Arterial Hypertension; Hypercholesterolemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Epidemiological intervention

An analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Center for Diabetes Control, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Efrain Rodriguez-Vigil, MD

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Efrain Rodriguez-Vigil, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Diabetes Control, Inc.

Other Identifiers

CD0108

Identifier Type: -

Identifier Source: org_study_id