An interventional study of education program in Diabetes Mellitus, sponsored by Université de Montréal. Completed at 1 site in Lebanon. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-04.
Sponsored by Université de Montréal · Not applicable, Interventional, and Prevention
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.
11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 108 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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.
Behavioral: education program
education program in 6 hours and monitoring phone every 15 days
adhesion
Time frame: HbA1c less than 7 % 3 months after the intervention
Self-management behaviors
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).
Time frame: improvement of self-management behaviors 3 months after the intervention
self-efficacy
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.
Time frame: enhancement of the sense of self-efficacy 3 months after the intervention
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Université de Montréal