An Analysis of Diabetes Control in Puerto Rico

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117831
• Other study ID #: CD0108
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: July 19, 2017
• Start date: March 2010
• Est. completion date: February 2013

Study information

• Verified date: July 2017
• Source: Center for Diabetes Control, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Hypertension
• Diabetes Mellitus
• Hypercholesterolemia
• Hypertension

Intervention

Other:
• Epidemiological intervention
An analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Center for Diabetes Control, Inc.	Eli Lilly and Company, Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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	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