About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Motivational Interviewing
BehavioralMotivational 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.
Treatment groups
Trial outcomes
Primary outcomes
Treatment Adherence
Treatment adherence measured using the Arabic version of the Adherence to Refills and Medications Scale (ARMS).
Self-Efficacy
Self-efficacy measured using the Arabic version of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS).
Secondary outcomes
Serum Ferritin Level
Change in serum ferritin level following the motivational interviewing intervention.
Hospital Admission Frequency
Number of thalassemia-related hospital admissions before and after the intervention.
Locations
Sponsors and contacts
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Oman Ministry of Health
Lead sponsor
Sultan Qaboos University
Sponsor institution
Sultan Qaboos University
Collaborator
Royal Hospital
Collaborator
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