An Analysis of Diabetes Control in Puerto Rico
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|ClinicalTrials.gov Identifier: NCT01117831|
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus Arterial Hypertension Hypercholesterolemia||Other: Epidemiological intervention|
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.
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|
|Actual Enrollment :||600 participants|
|Official Title:||An Analysis of Variables That Affect Quality of Diabetes Control in Puerto Rico|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||February 2013|
- Other: Epidemiological intervention
An analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control.
- Blood sugar control [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus [ Time Frame: 2 years ]Type of therapies used by these populations and their relationship with out of goals outcome.
- Achievement of National Clinical Practice Recommendations among Puerto Rican Population with Diabetes Mellitus [ Time Frame: 1 year ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117831
|Principal Investigator:||Efrain Rodriguez-Vigil, MD||Center for Diabetes Control, Inc.|