An Analysis of Diabetes Control in Puerto Rico

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Hypercholesterolemia; Arterial Hypertension
• Intervention / Treatment: Other: Epidemiological intervention

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 Type: Observational
• Enrollment (Actual): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus	Outcome measure assessment: Descriptive analysis will be computed to describe the demographic and health services characteristic of the participants. Bivariate analysis using contingency tables and the Pearson Chi-square test and independent samples t-tests will be conducted to determine whether or not there were differences between adults with diabetes and A1C levels lower than 7% and those with A1C levels greater than 7% in term of demographics, health services characteristics, health insurance type, type of providers, type of medication (insulin or pills) and comorbidities. For statistical analysis, alpha will be set at p < 0.05.	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 5, 2010
• First Posted (Estimate): May 6, 2010

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes mellitus
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertension; Diabetes Mellitus; Hypercholesterolemia
• Other Study ID Numbers: CD0108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: National Journal, Physician meeting, Press release
• IPD Sharing Time Frame: 2 years
• IPD Sharing Supporting Information Type: CSR