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The Effect of Motivational Interviewing on Treatment Adherence and Self-Efficacy Among Omani Adults With Thalassemia (MITAS)

16 juin 2026 mis à jour par: Mizna Said Al-Sinani, Oman Ministry of Health

The Effect of Motivational Interviewing on Treatment Adherence and Self-Efficacy Among Omani Adults With Beta-Thalassemia Major

Beta-thalassemia major is a chronic hereditary blood disorder that requires lifelong treatment, including regular blood transfusions and iron chelation therapy. Poor adherence to treatment remains a significant challenge and may lead to iron overload and related complications. Self-efficacy is an important factor influencing patients' ability to adhere to treatment recommendations.

This study aims to evaluate the effect of nurse-delivered Motivational Interviewing (MI) on treatment adherence and self-efficacy among Omani adults with beta-thalassemia major. A pre-experimental one-group repeated-measures design will be used. Approximately 45 participants will be recruited from the Oman National Center for Hematology and Bone Marrow Transplantation and Royal Hospital in Muscat, Oman.

Participants will receive three individualized MI sessions over a period of six to eight weeks. Treatment adherence and self-efficacy will be assessed at baseline, immediately after completion of the intervention, and at three-month follow-up. Secondary outcomes include serum ferritin level and frequency of thalassemia-related hospital admissions. The findings will provide evidence regarding the usefulness of motivational interviewing in improving adherence-related outcomes among adults with beta-thalassemia major.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Beta-thalassemia major is a lifelong transfusion-dependent condition that requires continuous adherence to iron chelation therapy to prevent iron overload and its associated complications. Despite advances in treatment, suboptimal adherence remains common among adults with beta-thalassemia major and contributes to increased morbidity and healthcare utilization. Self-efficacy has been identified as a key determinant of adherence behavior and may be enhanced through behavioral interventions.

This study will evaluate the effectiveness of a nurse-delivered Motivational Interviewing (MI) intervention on treatment adherence and self-efficacy among Omani adults with beta-thalassemia major. The study is guided by Social Cognitive Theory and uses a quantitative pre-experimental one-group repeated-measures design.

Eligible participants will be adults aged 18 years and older with beta-thalassemia major who are receiving regular follow-up and iron chelation therapy. Participants will be recruited from the Oman National Center for Hematology and Bone Marrow Transplantation, University Medical City, and Royal Hospital in Muscat, Oman.

The intervention consists of three individual motivational interviewing sessions delivered by a trained nurse over six to eight weeks. Each session will last approximately 30 minutes and will focus on exploring treatment-related challenges, enhancing motivation, strengthening self-efficacy, and supporting adherence to iron chelation therapy.

Primary outcomes include treatment adherence measured using the Arabic version of the Adherence to Refills and Medications Scale (ARMS) and self-efficacy measured using the Arabic version of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS). Assessments will be conducted at baseline, immediately after the intervention, and three months after completion of the intervention.

Secondary outcomes include changes in serum ferritin levels and thalassemia-related hospital admission frequency. Data will be analyzed using descriptive statistics and repeated-measures statistical tests to examine changes across study time points.

The results of this study may support the integration of motivational interviewing into routine nursing practice for adults with beta-thalassemia major and contribute to improving patient-centered chronic disease management in Oman.

Type d'étude

Interventionnel

Inscription (Estimé)

45

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

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 older.
  • Diagnosed with transfusion-dependent beta-thalassemia major.
  • Receiving iron chelation therapy for at least 6 months.
  • Receiving regular follow-up at the participating study sites.
  • Able to communicate in Arabic or English.
  • Willing and able to provide informed consent.
  • Able to attend the motivational interviewing sessions and complete study questionnaires.

Exclusion Criteria:

  • Current hospitalization for an acute medical condition at the time of recruitment.
  • Severe cognitive impairment or psychiatric illness that may affect participation.
  • Participation in another structured psychosocial or behavioral intervention program.
  • Unable or unwilling to provide informed consent.

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: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Motivational Interviewing Intervention
Participants will receive three individual motivational interviewing sessions delivered by a trained nurse over six to eight weeks. Each session will last approximately 30 minutes and will focus on enhancing treatment adherence, addressing barriers to iron chelation therapy, strengthening self-efficacy, and supporting self-management behaviors.
Comportemental: Motivational Interviewing
Motivational Interviewing is a patient-centered behavioral intervention designed to enhance intrinsic motivation for behavior change. Participants will receive three individualized sessions over six to eight weeks focusing on treatment adherence, self-efficacy, goal setting, and management of barriers related to iron chelation therapy.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Treatment Adherence
Délai: Baseline, post-intervention (after completion of the third motivational interviewing session), and 3-month follow-up
Treatment adherence measured using the Arabic version of the Adherence to Refills and Medications Scale (ARMS).
Baseline, post-intervention (after completion of the third motivational interviewing session), and 3-month follow-up
Self-Efficacy
Délai: Baseline, post-intervention (after completion of the third motivational interviewing session), and 3-month follow-up
Self-efficacy measured using the Arabic version of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS).
Baseline, post-intervention (after completion of the third motivational interviewing session), and 3-month follow-up

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Serum Ferritin Level
Délai: Baseline and 3-month follow-up
Change in serum ferritin level following the motivational interviewing intervention.
Baseline and 3-month follow-up
Hospital Admission Frequency
Délai: Three months before intervention compared with three months after intervention
Number of thalassemia-related hospital admissions before and after the intervention.
Three months before intervention compared with three months after intervention

Collaborateurs et enquêteurs

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

Parrainer

Oman Ministry of Health

Collaborateurs

Sultan Qaboos University
Royal Hospital

Les enquêteurs

  • Chercheur principal: Mizna Said Al-sinani, RN,BSN, Sultan Qaboos University

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 novembre 2026

Achèvement primaire (Estimé)

10 août 2027

Achèvement de l'étude (Estimé)

30 novembre 2027

Dates d'inscription aux études

Première soumission

16 juin 2026

Première soumission répondant aux critères de contrôle qualité

16 juin 2026

Première publication (Réel)

22 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MoH/CSR/26/32221

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 will not be shared to protect participant confidentiality and privacy.

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 .

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