An Analysis of Diabetes Control in Puerto Rico

Completed

• Conditions: Diabetes Mellitus; Arterial Hypertension; Hypercholesterolemia

• Registration Number: NCT01117831
• Lead Sponsor: Center for Diabetes Control, Inc.

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-06
• Primary Completion: 2012-11
• Study Completion: 2013-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood sugar control	2 years	Numbers of Patients with Hg A1C on control (less than 7%). Those with A1c greater than 7% will be considered as not meeting the goal
Blood pressure control	2 years	Blood Pressure Control: Patients will be considered out of blood pressure control if they have a systolic blood pressure greater than 130 mm Hg or a diastolic blood pressure greater than 80 mg Hg
Lipids goal achievement	2 years	The following lipids results will be considered out of goal for this population: LDL cholesterol greater than 100 mg/dL, HDL cholestero lower than 40 mg/dL in male and lower than 50 mg/dL in women, and serum triglycerides greater than 150 mg/dL

Secondary Outcome Measures

Name	Time	Method
Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus	2 years	Type of therapies used by these populations and their relationship with out of goals outcome.