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

16 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

45

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Treatment Adherence
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Serum Ferritin Level
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Oman Ministry of Health

Medewerkers

Sultan Qaboos University
Royal Hospital

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

10 augustus 2027

Studie voltooiing (Geschat)

30 november 2027

Studieregistratiedata

Eerst ingediend

16 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 juni 2026

Eerst geplaatst (Werkelijk)

22 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MoH/CSR/26/32221

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared to protect participant confidentiality and privacy.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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