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

NCT07660224 | Not Yet Recruiting

• 1 other identifier: MoH/CSR/26/32221
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Treatment Adherence

  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

  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

Secondary Outcomes (2)

• Serum Ferritin Level

  Baseline and 3-month follow-up

• Hospital Admission Frequency

  Three months before intervention compared with three months after intervention

Study Arms (1)

Motivational Interviewing Intervention

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing

Interventions

Motivational Interviewing BEHAVIORAL

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.

Motivational Interviewing Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oman Ministry of Health: lead
• Sultan Qaboos University: collaborator
• Royal Hospital: collaborator

MeSH Terms

Conditions

beta-Thalassemia; Treatment Adherence and Compliance; Thalassemia

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mizna Said Al-sinani, RN,BSN

  Sultan Qaboos University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mizna Said Al-sinani, RN, BSN

CONTACT

968-99851427; s100722@student.squ.edu.om

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science in Nursing Student

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): August 10, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share