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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Université de Montréal
Sponsor:
Information provided by (Responsible Party):
Randa Atallah, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01771887
First received: January 8, 2013
Last updated: March 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Behavioral: education program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • adhesion [ Time Frame: HbA1c less than 7 % 3 months after the intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-management behaviors [ Time Frame: improvement of self-management behaviors 3 months after the intervention ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • self-efficacy [ Time Frame: enhancement of the sense of self-efficacy 3 months after the intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 240
Study Start Date: January 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: education program
education program in 6 hours and monitoring phone every 15 days

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771887

Contacts
Contact: Jose COTE, nur,PhD. 514-8908000 ext 15536 jose.cote@umontreal.ca
Contact: Randa BOU-RIZK ATALLAH, nur,cand PhD 961-1421000 ext 2140 randa.atallah@usj.edu.lb

Locations
Lebanon
Outpatient of hospital of Hotel Dieu de France Not yet recruiting
Beirut, Lebanon, 16-6830
Contact: Claire ZABLIT, MBA    961-1421000 ext 2142    claire.zablit@usj.edu.lb   
Contact: Rima SASSINE, nurse,PhD    961-1421000 ext 2171    rima.sassine@usj.edu.lb   
Principal Investigator: Randa BOU-RIZK ATALLAH, nur cand PhD         
Principal Investigator: Randa BOU-RIZK ATALLAH, nur candPhd         
Sponsors and Collaborators
Université de Montréal
Investigators
Study Director: José Côté, nur. Ph. D. Université de Montréal
  More Information

No publications provided

Responsible Party: Randa Atallah, Ph.D. Candidate, Université de Montréal
ClinicalTrials.gov Identifier: NCT01771887     History of Changes
Other Study ID Numbers: ATALLAH-FSI-6
Study First Received: January 8, 2013
Last Updated: March 18, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Montréal:
Diabetic Type2
education
self-management behaviors
self-efficacy
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014