An Analysis of Diabetes Control in Puerto Rico

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Arterial Hypertension, Hypercholesterolemia

Intervention / Treatment
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* Other: Epidemiological intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Epidemiological intervention|An analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sugar control | 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 | 2 years | 
| Blood pressure control | 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 | 2 years | 
| Lipids goal achievement | 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus | Type of therapies used by these populations and their relationship with out of goals outcome. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus