Clinical trial NCT01771887: Effects of Education Program for Lebanese Diabetic T2 in Their Behavior of Auto Managing, of Self-efficacy and Adhesion
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetic Type2
education
self-management behaviors
self-efficacy
HbA1c
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 1. 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.
2. 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.
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: adhesion
timeFrame: HbA1c less than 7 % 3 months after the intervention
Secondary outcomes:
measure: Self-management behaviors
timeFrame: improvement of self-management behaviors 3 months after the intervention
Other outcomes:
measure: self-efficacy
timeFrame: enhancement of the sense of self-efficacy 3 months after the intervention
Locations:
city: Beirut
country: Lebanon
facility: Outpatient of hospital of Hotel Dieu de France
Study officials:
affiliation: Université de Montréal
name: José Côté, nur. Ph. D.
role: STUDY_DIRECTOR
References: