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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOman Ministry of Health

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Motivational Interviewing InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment Adherence

Treatment adherence measured using the Arabic version of the Adherence to Refills and Medications Scale (ARMS).

Time frame
Baseline, post-intervention (after completion of the third motivational interviewing session), and 3-month follow-up
2

Self-Efficacy

Self-efficacy measured using the Arabic version of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS).

Time frame
Baseline, post-intervention (after completion of the third motivational interviewing session), and 3-month follow-up

Secondary outcomes

1

Serum Ferritin Level

Change in serum ferritin level following the motivational interviewing intervention.

Time frame
Baseline and 3-month follow-up
2

Hospital Admission Frequency

Number of thalassemia-related hospital admissions before and after the intervention.

Time frame
Three months before intervention compared with three months after intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oman Ministry of Health

Lead sponsor

Sultan Qaboos University

Sponsor institution

Sultan Qaboos University

Collaborator

Royal Hospital

Collaborator

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