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

NCT01771887 | Completed

• 1 other identifier: ATALLAH-FSI-6
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetic Type2; education; self-management behaviors; self-efficacy; HbA1c

Outcome Measures

Primary Outcomes (1)

• adhesion

  HbA1c less than 7 % 3 months after the intervention

Secondary Outcomes (1)

• Self-management behaviors

  improvement of self-management behaviors 3 months after the intervention

Other Outcomes (1)

• self-efficacy

  enhancement of the sense of self-efficacy 3 months after the intervention

Study Arms (1)

education program

EXPERIMENTAL

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

Interventions

education program BEHAVIORAL

education program in 6 hours and monitoring phone every 15 days

education program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over,
• Suffering from type 2 diabetes for at least one year,
• Lebanese speak, read and write Arabic,
• Have an HbA1c ≥ 7%

You may not qualify if:

• mental impairment
• a psychological problem uncontrolled and medicated

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

Outpatient of hospital of Hotel Dieu de France

Beirut, 16-6830, Lebanon

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• José Côté, nur. Ph. D.

  Université de Montréal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Candidate

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 18, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

LE (1)