Trials / Completed
CompletedNCT01117831
An Analysis of Diabetes Control in Puerto Rico
An Analysis of Variables That Affect Quality of Diabetes Control in Puerto Rico
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (actual)
- Sponsor
- Center for Diabetes Control, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Epidemiological intervention | An analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control. |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2012-11-01
- Completion
- 2013-02-01
- First posted
- 2010-05-06
- Last updated
- 2017-07-21
Source: ClinicalTrials.gov record NCT01117831. Inclusion in this directory is not an endorsement.