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Effects of Education Program for Lebanese Diabetic T2 in Their Behavior of Auto Managing, of Self-efficacy and Adhesion

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
education program
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring Diabetic Type2, education, self-management behaviors, self-efficacy, HbA1c

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Outpatient of hospital of Hotel Dieu de France

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

education program

Arm Description

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.

Outcomes

Primary Outcome Measures

adhesion

Secondary Outcome Measures

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).

Full Information

First Posted
January 8, 2013
Last Updated
December 3, 2014
Sponsor
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT01771887
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetic Type2, education, self-management behaviors, self-efficacy, HbA1c

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
education program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
education program
Intervention Description
education program in 6 hours and monitoring phone every 15 days
Primary Outcome Measure Information:
Title
adhesion
Time Frame
HbA1c less than 7 % 3 months after the intervention
Secondary Outcome Measure Information:
Title
Self-management behaviors
Description
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
Other Pre-specified Outcome Measures:
Title
self-efficacy
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Côté, nur. Ph. D.
Organizational Affiliation
Université de Montréal
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient of hospital of Hotel Dieu de France
City
Beirut
ZIP/Postal Code
16-6830
Country
Lebanon

12. IPD Sharing Statement

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Effects of Education Program for Lebanese Diabetic T2 in Their Behavior of Auto Managing, of Self-efficacy and Adhesion

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