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| Name | Class |
|---|---|
| Sultan Qaboos University | OTHER |
| Royal Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Ferritin Level | Change in serum ferritin level following the motivational interviewing intervention. | Baseline and 3-month follow-up |
| Hospital Admission Frequency | Number of thalassemia-related hospital admissions before and after the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mizna Said Al-sinani, RN, BSN | Contact | 968-99851427 | s100722@student.squ.edu.om |
| Name | Affiliation | Role |
|---|---|---|
| Mizna Said Al-sinani, RN,BSN | Sultan Qaboos University | Principal Investigator |
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Individual participant data will not be shared to protect participant confidentiality and privacy.
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| ID | Term |
|---|---|
| D017086 | beta-Thalassemia |
| D000074822 | Treatment Adherence and Compliance |
| D013789 | Thalassemia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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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.
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|
| Three months before intervention compared with three months after intervention |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |