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IRCT20260911071006N1 IRCT 2026-10-07 Rafsanjan University of Medical Sciences Investigating the Effect of the Family-Centered Empowerment Model on the Resilience of Patients with Multiple Sclerosis Investigating the Effect of the Family-Centered Empowerment Model on the Resilience of Patients with Multiple Sclerosis 2026-10-15 anticipated 64 Recruiting https://irct.ir/trial/93307 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, following protocol approval and receipt of an ethics code from the Ethics Committee in Research of Rafsanjan University of Medical Sciences, the researchers will visit the MS Society center of Rafsanjan, and from among the total multiple sclerosis patients who are members of or have records at this center, 64 eligible patients will be selected using purposive sampling. To ensure homogeneity between the groups in terms of functional dependency level, a Stratified Random Allocation method will be used. First, in the initial stage, participants will be divided into two strata based on their Barthel Index scores: stratum one (high functional dependency, score 20–61) and stratum two (low functional dependency, score 62–90). In the second stage, for each stratum, participants will be randomly distributed (using a lottery method) between the intervention and control groups, such that ultimately each group will consist of 32 participants with a balanced distribution from both strata. After explaining the research objectives and obtaining informed, written consent from participants, the initial assessment stage (pre-test) will be conducted. At this stage, the demographic characteristics questionnaire, the Barthel functional index, and the Connor-Davidson Resilience Scale (CD-RISC) will be completed via self-report by participants in both the intervention and control groups. Subsequently, participants in the intervention group will take part in an educational program based on the "Family-Centered Empowerment Model" (FCEM). This intervention will be delivered in a group format, with the active participation of one family member (primary caregiver), at the MS Society center of Rafsanjan, Blinding description: Given the educational and participatory nature of the intervention (active involvement of the patient and primary caregiver in group sessions), blinding of participants and the intervention provider was not feasible. To reduce bias in data collection and analysis, a single-blind method will be used: questionnaires completed at the three time points (Pre-test, Post-test, and Follow-up) will be given to the person responsible for data entry and analysis using only a numeric identification code, without any name or group label (intervention/control). The table matching participant codes to their assigned group will be kept by the principal researcher and will not be made available to the data analyst until data entry is complete and the initial analyses have been carried out. N/A Multiple Sclerosis. Intervention 1: Intervention group: Participants in the intervention group will take part in an educational program based on the "Family-Centered Empowerment Model" (FCEM). This intervention will be delivered in a group format, with the active participation of one family member (primary caregiver), at the MS Society center of Rafsanjan. The educational protocol consists of 4 sessions of 90 minutes each (held at weekly intervals) and is designed around the following four operational steps:Session 1 (Orientation and Threat Perception): Through lectures and group discussion, patients' and their families' awareness and understanding of the nature of MS, its complications, aggravating factors, and factors effective in disease control are increased.Session 2 (Self-Efficacy/Problem-Solving): Patients and their families are confronted with the real-life problems of living with MS, and through group discussion and exchange of experience, they learn practical strategies for problem-solving and disease management.Session 3 (Self-Belief/Self-Confidence): The patient is asked to review the educational material from previous sessions with the help of the active family member and convey it to other family members, so as to strengthen their self-confidence and sense of mastery over the disease.Session 4 (Evaluation): Through questions and answers and group discussion, the patients' and families' level of learning and any remaining ambiguities are assessed. Intervention 2: Control group: In addition to receiving routine care, the control group will not receive any educational intervention. To adhere to research ethics, the educational package (including PowerPoint files and educational content) will be provided to members of the control group upon completion of the study. Yes - There is a plan to make this available What will be shared: Some of the data—such as information regarding the primary outcome or the like—can be shared. When: Access period begins 6 months after the publication of results. To whom: All people interested in the research topic Conditions: All researchers interested in the topic of my intervention Where to obtain: Via my email at shayanorafa81@gmail.com How to obtain: Please submit your request via email or by sending a text message to 09381914125 (registered on Eitaa or WhatsApp). Comments:
public Shayan Orafa
Rafsanjan, Mostafa Khomeini Street, Alley
Rafsanjan Iran (Islamic Republic of) 7714668433 +98 34 3422 4297 shayanorafa81@gmail.com Rafsanjan University of Medical Sciences scientific Shayan Orafa
No. 42, Alley 39, Mostafa Khomeini Street, Partovi Square, Rafsanjan
Rafsanjan Iran (Islamic Republic of) 7714668433 +98 34 3422 4297 shayanorafa81@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) • Definitive diagnosis of Multiple Sclerosis (MS) by a neurologist • Age range: 18 to 65 years Having a performance score between 20 and 90 on the Barthel Index to ensure the desired level of dependency. • Having at least one primary caregiver (family member) willing to actively participate in training sessions. • Ability to understand instructions and respond to questionnaires (self-report) • Obtaining written informed consent for participation in all stages of the research. • No prior participation in similar training programs 18 years 65 years Both A score of less than 20 or greater than 90, due to the patient's complete independence or severe dependency. G35 Multiple sclerosis Behavior Behavior Intervention group: Participants in the intervention group will take part in an educational program based on the "Family-Centered Empowerment Model" (FCEM). This intervention will be delivered in a group format, with the active participation of one family member (primary caregiver), at the MS Society center of Rafsanjan. The educational protocol consists of 4 sessions of 90 minutes each (held at weekly intervals) and is designed around the following four operational steps:Session 1 (Orientation and Threat Perception): Through lectures and group discussion, patients' and their families' awareness and understanding of the nature of MS, its complications, aggravating factors, and factors effective in disease control are increased.Session 2 (Self-Efficacy/Problem-Solving): Patients and their families are confronted with the real-life problems of living with MS, and through group discussion and exchange of experience, they learn practical strategies for problem-solving and disease management.Session 3 (Self-Belief/Self-Confidence): The patient is asked to review the educational material from previous sessions with the help of the active family member and convey it to other family members, so as to strengthen their self-confidence and sense of mastery over the disease.Session 4 (Evaluation): Through questions and answers and group discussion, the patients' and families' level of learning and any remaining ambiguities are assessed. Control group: In addition to receiving routine care, the control group will not receive any educational intervention. To adhere to research ethics, the educational package (including PowerPoint files and educational content) will be provided to members of the control group upon completion of the study. Resilience of Patients with Multiple Sclerosis. Timepoint: Determination of patients' resilience scores before, immediately after, and one month after the intervention. Method of measurement: Connor-Davidson Resilience Scale. Rafsanjan University of Medical Sciences Approved 2026-10-05 Ethics committee of Rafsanjan University of Medical Sciences No. 42, Alley 39, Mostafa Khomeini Street, Partovi Square, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)