Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Effectiveness of a Self-Efficacy Based Educational Program on Glycemic Self-Monitoring, Diabetes Self-Management Knowledge, and Health-Related Quality of Life Among Adults With Type 2 Diabetes Mellitus (T2DM-SM-QOL-)

30 avril 2026 mis à jour par: JAWAD AHMAD ABU-SHENNAR, Jerash Private University

Effectiveness of a Self-Efficacy-Based Educational Program on Glycemic Self-Monitoring, Diabetes Self-Management Knowledge, and Health-Related Quality of Life Among Adults With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effectiveness of a self-efficacy-based educational program on glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life among adults with Type 2 Diabetes Mellitus. Participants will be randomly assigned to either an intervention group receiving the educational program or a control group receiving standard care.

The educational program is designed to enhance patients' confidence (self-efficacy) in managing their condition, including blood glucose monitoring, adherence to treatment, lifestyle modification, and self-care practices. Outcomes will be assessed using validated tools to measure improvements in self-monitoring behaviors, knowledge, and quality of life.

The findings of this study are expected to provide evidence on the effectiveness of educational interventions in improving diabetes management and patient outcomes.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

Type 2 Diabetes Mellitus is a chronic metabolic disorder that requires continuous self-management, including blood glucose monitoring, medication adherence, diet control, and lifestyle modification. Poor self-management is associated with increased risk of complications and reduced quality of life.

Self-efficacy, defined as an individual's belief in their ability to perform specific behaviors, plays a critical role in diabetes self-management. Educational interventions based on self-efficacy theory have shown potential in improving patients' confidence and ability to manage their condition effectively.

This study is a randomized controlled trial designed to evaluate the effectiveness of a self-efficacy-based educational program among adults with Type 2 Diabetes Mellitus. A total of 400 participants will be recruited and randomly assigned to either the intervention group or the control group.

Participants in the intervention group will receive a structured educational program focusing on enhancing self-efficacy related to glycemic self-monitoring, diabetes knowledge, and self-care behaviors. The program will include interactive sessions, practical demonstrations, and educational materials. The control group will receive standard care provided by healthcare services.

Data will be collected at baseline and after the intervention using validated instruments to assess glycemic self-monitoring practices, diabetes self-management knowledge, and health-related quality of life.

The primary outcomes of this study include improvement in glycemic self-monitoring behaviors and diabetes-related knowledge. Secondary outcomes include improvement in health-related quality of life.

The results of this study are expected to contribute to the growing body of evidence supporting the role of self-efficacy-based interventions in chronic disease management and may inform future clinical practice and educational strategies.

Type d'étude

Interventionnel

Inscription (Estimé)

400

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Jawad ABU-SHENNAR, Asst.Prof.Dr
  • Numéro de téléphone: +962779084560
  • E-mail: JAWAD_0799@YAHOO.COM

Lieux d'étude

    • Dours
      • Jerash, Dours, Jordan, 009627
        • Ministry of Health Primary Healthcare Centers
        • Contact:
          • Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
          • Numéro de téléphone: 0779084560
          • E-mail: JAWAD_0799@YAHOO.COM
        • Contact:
        • Chercheur principal:
          • Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Adults aged 18 years and above
  • Diagnosed with Type 2 Diabetes Mellitus (T2DM)
  • Attending Jordanian Ministry of Health healthcare facilities for at least six months with regular follow-up visits
  • Able to perform or learn self-monitoring of blood glucose (SMBG)
  • Able to use a glucometer independently
  • Willing to participate and provide informed consent

Exclusion Criteria:

  • Patients with Type 1 diabetes mellitus or gestational diabetes
  • Patients with physical or cognitive impairments that limit the ability to perform SMBG independently
  • Pregnant or lactating women
  • Patients with severe medical conditions such as renal failure or cardiovascular instability that may affect participation
  • Patients with other conditions that may hinder study participation
  • Patients who do not provide informed consent
  • Patients who fail to respond to study instruments
  • Patients who participated in similar educational programs within the past six months
  • Patients currently using corticosteroid medications due to their effect on blood glucose levels

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Self-Efficacy Educational Program Groups

Participants in this arm will receive a structured self-efficacy-based educational program designed to improve glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life among adults with Type 2 Diabetes Mellitus. The intervention is based on self-efficacy theory and focuses on enhancing patients' confidence in performing diabetes self-care behaviors.

The program is delivered through structured educational sessions conducted by trained healthcare professionals. It includes interactive lectures, group discussions, demonstrations, and practical training covering blood glucose self-monitoring, medication adherence, dietary management, physical activity, and prevention of diabetes-related complications.

Educational materials such as printed handouts and visual aids are provided to reinforce learning. The intervention is delivered over a defined number of sessions within a specific timeframe.

A structured self-efficacy-based educational program designed for adults with Type 2 Diabetes Mellitus to improve glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life. The program is grounded in self-efficacy theory and aims to enhance patients' confidence in performing diabetes self-care behaviors.

The intervention is delivered through scheduled educational sessions conducted by trained healthcare professionals and includes interactive lectures, group discussions, demonstrations, and practical training. Key topics include blood glucose self-monitoring, medication adherence, dietary management, physical activity, complication prevention, and problem-solving strategies for diabetes self-care.

Educational materials such as printed booklets and visual aids are used to reinforce learning. The program is implemented over a defined number of sessions within a specified period, while the control group receives standard routine care only.

Comparateur actif: Control Group

Participants in this arm will receive standard routine care for Type 2 Diabetes Mellitus as provided in usual clinical practice at the healthcare facilities. This includes regular follow-up visits, general medical advice, and standard education related to diabetes management as offered by healthcare providers.

No structured or additional self-efficacy-based educational program will be provided to this group. Participants will continue their usual care without any additional intervention from the research team.

A structured self-efficacy-based educational program designed for adults with Type 2 Diabetes Mellitus to improve glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life. The program is grounded in self-efficacy theory and aims to enhance patients' confidence in performing diabetes self-care behaviors.

The intervention is delivered through scheduled educational sessions conducted by trained healthcare professionals and includes interactive lectures, group discussions, demonstrations, and practical training. Key topics include blood glucose self-monitoring, medication adherence, dietary management, physical activity, complication prevention, and problem-solving strategies for diabetes self-care.

Educational materials such as printed booklets and visual aids are used to reinforce learning. The program is implemented over a defined number of sessions within a specified period, while the control group receives standard routine care only.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Diabetes Self-Management Behaviors Measured Using the Diabetes Self-Management Questionnaire (DSMQ)
Délai: Baseline and 3 months after intervention
Change in diabetes self-management behaviors measured using the Diabetes Self-Management Questionnaire (DSMQ). The DSMQ is a 16-item validated self-report instrument developed by Schmitt et al. (2013) to assess diabetes self-care behaviors that influence glycemic control, including glucose management, dietary control, physical activity, and healthcare utilization. Items are rated on a Likert scale, with higher scores indicating better self-management.
Baseline and 3 months after intervention

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Diabetes Knowledge Measured Using the Diabetes Knowledge Questionnaire (DKQ)
Délai: Baseline and 3 months post-intervention
Change in diabetes knowledge measured using the Diabetes Knowledge Questionnaire (DKQ). The DKQ is a validated 24-item instrument developed to assess patients' understanding of diabetes management, including causes, symptoms, complications, diet, exercise, medication adherence, and blood glucose control. Items are answered in a Yes/No/Don't know format, with one point awarded for each correct answer. Total scores range from 0 to 24, with higher scores indicating greater diabetes knowledge.
Baseline and 3 months post-intervention

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Health-Related Quality of Life Measured Using the EQ-5D-5L Questionnaire
Délai: Baseline and 3 months post-intervention
Change in health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a 5-level scale ranging from no problems to extreme problems. The EQ-5D index score typically ranges from values below 0 (worse than death) to 1 (full health), where higher scores indicate better health-related quality of life. Additionally, overall health status is assessed using the EQ Visual Analog Scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Baseline and 3 months post-intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr, Jerash University, Faculty of Nursing

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 mai 2026

Achèvement primaire (Estimé)

1 mai 2026

Achèvement de l'étude (Estimé)

1 octobre 2026

Dates d'inscription aux études

Première soumission

24 avril 2026

Première soumission répondant aux critères de contrôle qualité

30 avril 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data (IPD) will not be shared because this study involves human subjects data collected for academic and institutional research purposes. Data confidentiality and participant privacy will be strictly maintained in accordance with ethical guidelines and institutional review board (IRB) requirements. Only aggregated results will be reported and published, and individual-level data will not be made publicly available.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner