Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

16. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment Adherence
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum Ferritin Level
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Oman Ministry of Health

Samarbejdspartnere

Sultan Qaboos University
Royal Hospital

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

10. august 2027

Studieafslutning (Anslået)

30. november 2027

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MoH/CSR/26/32221

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Beta-thalassæmi major

Kliniske forsøg med Motivational Interviewing

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Zimbabwe

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner