Clinical trial NCT01117831: An Analysis of Diabetes Control in Puerto Rico
Official title: An Analysis of Variables That Affect Quality of Diabetes Control in Puerto Rico
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Arterial Hypertension
Hypercholesterolemia
Keywords: Diabetes mellitus
Lead sponsor: Center for Diabetes Control, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novo Nordisk A/S
name: Eli Lilly and Company
First posted: 2010-05-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Blood sugar control
timeFrame: 2 years
measure: Blood pressure control
timeFrame: 2 years
measure: Lipids goal achievement
timeFrame: 2 years
Secondary outcomes:
measure: Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus
timeFrame: 2 years
Other outcomes:
measure: Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus
timeFrame: 1 year
Locations:
Study officials:
affiliation: Center for Diabetes Control, Inc.
name: Efrain Rodriguez-Vigil, MD
role: PRINCIPAL_INVESTIGATOR
References: