- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01771887
Effects of Education Program for Lebanese Diabetic T2 in Their Behavior of Auto Managing, of Self-efficacy and Adhesion
December 3, 2014 updated by: Randa Atallah, Université de Montréal
Assessing the Effects of Education Program for Lebanese Diabetic Type 2 in Their Behavior of Auto Managing Their Sense of Self-efficacy and on Their Adhesion Therapy
Diabetes mellitus is a disease of great frequency and is a major public health problem.
In Lebanon, the incidence of diabetes is estimated at 12%, it is expected to double by the year 2025.
Given the increasing prevalence of diabetes in Lebanon, the evolution of complications of this disease and the lack of studies at this level, it is appropriate to conduct a study that aims to evaluate the effects an education program for people with type 2 diabetes on their sense of self-efficacy and their ability to self-manage their disease to make them the most optimal therapeutic adherence possible.
The design of this study is experimental type before / after randomization by diabetic patients.
Education program delivered to the experimental group is the "Accu-Chek Education Program" of Roche.
Membership will be assessed using a biomarker HbA1c should be <7%, and a questionnaire (Summary of Diabetes Self-Care Activities Measure), which measures self-care behaviors.
Self-efficacy is measured using the Diabetes Management Self-Efficacy Scale.
And this before the intervention and 3 months later.
The sample will be 240 diabetic patients T2.
Recruitment will be in outpatient diabetology a Hospital located in Beirut.
Statistical analyzes used for descriptive variables are measures of central tendency, dispersion and frequency distribution.
T-test and chi-square will be used to compare the socio-demographic characteristics of the 2 groups, experimental and control.
To test hypotheses and determine the difference in the results of the dependent variables of the 2 groups, analysis of variance and covariance are used.
The data will be processed using SPSS version 14.0.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Following the implementation of a program of education, feeling of self-efficacy participants will be higher in the experimental group than in the control group.
- Following the implementation of a program of education, self-management behaviors: monitoring the diet, the practice of physical exercise, self-monitoring blood sugar, taking medications and care feet, participants will be higher in the experimental group than in the control group.
- Following the implementation of a program of education, the percentage of participants who have an HbA1c less than 7 will be higher in the experimental group than in the control group.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beirut, Lebanon, 16-6830
- Outpatient of hospital of Hotel Dieu de France
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years and over,
- Suffering from type 2 diabetes for at least one year,
- Lebanese speak, read and write Arabic,
- Have an HbA1c ≥ 7%
Exclusion Criteria:
- mental impairment
- a psychological problem uncontrolled and medicated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: education program
education program in 6 hours for groups of 10 people.
The content will be divided into 2 sessions with an interval of 2 weeks, the duration of each session is 3 hours.
Means active learning, teaching materials in Arabic accompany the content masterful discussions on flipcharts, situation analysis, computer-assisted presentation, demonstration, 150 photos of Lebanese dishes.
After, patients receive a 10-page illustrated book, a logbook of diabetes control. 2 weeks after the second education session, each participant will receive 5 calls every 15 days in 2 months.
During each call, the research assistant will ask the patient about diet, exercise and self-monitoring, medication and foot care and this according to a checklist.
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education program in 6 hours and monitoring phone every 15 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
adhesion
Time Frame: HbA1c less than 7 % 3 months after the intervention
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HbA1c less than 7 % 3 months after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-management behaviors
Time Frame: improvement of self-management behaviors 3 months after the intervention
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self-management behaviors will be measured using a questionnaire of 25 questions, Summary of Diabetes Self-Care Activities Measure SDSCA, which measures five behaviors: diet, exercise, self monitoring blood glucose, medication and foot care (Toobert et al., 2000).
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improvement of self-management behaviors 3 months after the intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self-efficacy
Time Frame: enhancement of the sense of self-efficacy 3 months after the intervention
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Self-efficacy is measured using the Diabetes Management Self-Efficacy Scale (DMSES).
This instrument was developed in 1999 by van der Bijl, van Poelgeest-Shortridge-Bagget & Eeltink.
This instrument consists of 20 items.
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enhancement of the sense of self-efficacy 3 months after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: José Côté, nur. Ph. D., Université de Montréal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 8, 2013
First Submitted That Met QC Criteria
January 16, 2013
First Posted (Estimate)
January 18, 2013
Study Record Updates
Last Update Posted (Estimate)
December 4, 2014
Last Update Submitted That Met QC Criteria
December 3, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATALLAH-FSI-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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