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Completed

NCT Number: NCT01771887

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient of hospital of Hotel Dieu de France

Beirut, 16-6830, Lebanon

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education program

Behavioral

education program in 6 hours and monitoring phone every 15 days

Primary outcomes

  1. adhesion

    Time frame: HbA1c less than 7 % 3 months after the intervention

Secondary outcomes

  1. Self-management behaviors

    Time frame: improvement of self-management behaviors 3 months after the intervention

    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 outcomes

  1. self-efficacy

    Time frame: enhancement of the sense of self-efficacy 3 months after the intervention

    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.

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 18, 2013
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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