An Analysis of Diabetes Control in Puerto Rico
|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|
|Primary Completion Date :||November 2012|
|Study Completion Date :||February 2013|
Other: Epidemiological intervention
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117831
|Principal Investigator:||Efrain Rodriguez-Vigil, MD||Center for Diabetes Control, Inc.|