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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07660224
Acronym
MITAS
Enrollment
45
Registered
2026-06-22
Start date
2026-11-01
Completion date
2027-11-30
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta-Thalassemia Major, Transfusion-Dependent Thalassemia

Keywords

Motivational Interviewing, Beta-Thalassemia Major, Treatment Adherence, Self-Efficacy, Iron Chelation Therapy, Adult Patients, Nursing Intervention, Thalassemia, Oman

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALMotivational 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.

Sponsors

Oman Ministry of Health
Lead SponsorOTHER_GOV
Sultan Qaboos University
CollaboratorOTHER
Royal Hospital
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A single-group pre-experimental repeated-measures study design will be used. All participants will receive three motivational interviewing sessions over six to eight weeks. Outcome measures will be assessed at baseline, after completion of the intervention, and at three-month follow-up.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Treatment AdherenceBaseline, post-intervention (after completion of the third motivational interviewing session), and 3-month follow-upTreatment adherence measured using the Arabic version of the Adherence to Refills and Medications Scale (ARMS).
Self-EfficacyBaseline, post-intervention (after completion of the third motivational interviewing session), and 3-month follow-upSelf-efficacy measured using the Arabic version of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS).

Secondary

MeasureTime frameDescription
Serum Ferritin LevelBaseline and 3-month follow-upChange in serum ferritin level following the motivational interviewing intervention.
Hospital Admission FrequencyThree months before intervention compared with three months after interventionNumber of thalassemia-related hospital admissions before and after the intervention.

Contacts

CONTACTMizna Said Al-sinani, RN, BSN
s100722@student.squ.edu.om968-99851427
PRINCIPAL_INVESTIGATORMizna Said Al-sinani, RN,BSN

Sultan Qaboos University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026