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IRCT20260705070075N1 IRCT 2026-07-25 Bandare-abbas University of Medical Sciences Investigating the impact of an education based on Leventhal's self-regulation model on resilience and treatment adherence among patients with kidney failure undergoing hemodialysis Investigating the impact of an education based on Leventhal's self-regulation model on resilience and treatment adherence among patients with kidney failure undergoing hemodialysis 2026-08-23 anticipated 102 Recruiting https://irct.ir/trial/91502 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, random permuted block randomization will be used for ensure a balanced allocation of participants between the intervention and control groups throughout the study period. The randomization procedure was conducted as follows: Block Size A block size of four is selected. A total of 26 blocks, each containing four allocations, are generated. Generation of All Possible Block Combinations All possible allocation sequences for blocks of four participants, with two assignments to each group (A = intervention and B = control), are generated (e.g., AABB, ABAB, ABBA, BAAB, BABA, BBAA). Random Generation of the Allocation Sequence The random allocation sequence is generated using Random Allocation Software (RAS). The software randomly arranges the blocks to minimize selection bias and ensure an unpredictable allocation sequence. Allocation of Participants After confirming eligibility and obtaining written informed consent, each participant is assigned to either the intervention or control group according to the predetermined randomization sequence. Following the enrollment of eligible patients and the completion of informed consent forms, participants will be allocated to either the intervention or control group according to a randomized list. Allocation Concealment Allocation sequences will be placed in sequentially numbered, opaque, sealed envelopes (SNOSE), which will only be opened at the time of patient enrollment. This procedure aims to prevent selection bias during the allocation process. This procedure prevents foreknowledge of treatment assignments and reduces allocation bias. Randomization Management and Documentation The entire randomization process is managed by an independent researcher who is not involved in participant recruitment, intervention delivery, or outcome assessment. The randomization list and related documentation are securely maintained and archived throughout the study, Blinding description: Blinding of Outcome Assessors Outcome assessors are responsible for collecting study outcome data (e.g., treatment adherence and resilience). To ensure assessor blinding, the following procedures will be implemented: Participant Coding: Following random allocation to the intervention or control group, each participant will be assigned a unique identification code. These codes will be used in place of any information indicating group allocation. For example, a participant assigned to the intervention group may be identified as P001, while a participant in the control group may be be identified as P002. The identification codes will not reveal participants' group assignments. Separation of Assessors from the Randomization Process: Outcome assessors will not be involved in the randomization or allocation of participants to the study groups. Randomization will be performed by an independent research team. Assessors will work exclusively with anonymized participant codes and outcome data. Restricted Access to Participant Information: Outcome assessors will have access only to the information necessary for data collection (e.g., treatment adherence scores and resilience scores). They will not have access to any information regarding participants' group allocation. Training of Outcome Assessors: Before the commencement of the study, all outcome assessors will receive standardized training emphasizing the importance of maintaining blinding and avoiding any attempts to identify participants' treatment assignments throughout the study. N/A patients undergoing hemodialysis. Intervention 1: At baseline, participants will complete the Connor–Davidson Resilience Scale (CD-RISC) and the Modanloo Treatment Adherence Questionnaire. The intervention will consist of six educational sessions lasting 60–75 minutes each, based on Leventhal's Self-Regulation Model. The sessions will address end-stage kidney disease, causes and management of the disease, illness perceptions, treatment adherence, resilience, personal and treatment control, emotional regulation, self-care planning, and available support resources. Immediately after completing the six-session program and again one month later, participants will complete the CD-RISC and the Modanloo Treatment Adherence Questionnaire. The educational content will be reviewed and approved for content validity by a nephrologist, a psychologist, and five nursing faculty members. Intervention 2: Before the educational intervention (baseline), participants will complete the Connor–Davidson Resilience Scale (CD-RISC) and the Modanloo Treatment Adherence Questionnaire. Immediately after completion of the 6 session educational intervention, participants will again complete the Connor–Davidson Resilience Scale and the Modanloo Treatment Adherence Questionnaire. Finally, one month after completion of the educational intervention, participants will complete the Connor–Davidson Resilience Scale and the. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Sayyed Hamidreza Mohebi
Keyvan alley, Khalij e fars street
Bandarabbas Iran (Islamic Republic of) 7919784349 +98 76 3375 0668 hamidrezamoh79@gmail.com Bandare-abbas University of Medical Sciences scientific Sayyed Hamidreza Mohebi
Keyvan alley, Khalij e fars street
Bandarabbas Iran (Islamic Republic of) 7919784349 +98 76 3375 0668 hamidrezamoh79@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) The patient is between 18 and 65 years of age.The patient is literate and able to read and complete the questionnaire.The patient has no diagnosed cognitive or psychiatric disorders.The patient is able to communicate effectively.The patient is able to use social media applications.The patient is willing to participate in the study and provides written informed consent. 18 years 65 years Both The patient withdraws from the study at any time. The patient is hospitalized during the study period. The patient has previously participated in another educational intervention. The patient dies during the study period. N18.6 End stage renal disease Other Other At baseline, participants will complete the Connor–Davidson Resilience Scale (CD-RISC) and the Modanloo Treatment Adherence Questionnaire. The intervention will consist of six educational sessions lasting 60–75 minutes each, based on Leventhal's Self-Regulation Model. The sessions will address end-stage kidney disease, causes and management of the disease, illness perceptions, treatment adherence, resilience, personal and treatment control, emotional regulation, self-care planning, and available support resources. Immediately after completing the six-session program and again one month later, participants will complete the CD-RISC and the Modanloo Treatment Adherence Questionnaire. The educational content will be reviewed and approved for content validity by a nephrologist, a psychologist, and five nursing faculty members. Before the educational intervention (baseline), participants will complete the Connor–Davidson Resilience Scale (CD-RISC) and the Modanloo Treatment Adherence Questionnaire. Immediately after completion of the 6 session educational intervention, participants will again complete the Connor–Davidson Resilience Scale and the Modanloo Treatment Adherence Questionnaire. Finally, one month after completion of the educational intervention, participants will complete the Connor–Davidson Resilience Scale and the Resilience. Timepoint: Before the intervention, immediately after the intervention, and one month after the intervention. Method of measurement: Connor–Davidson Resilience Scale (CD-RISC). Treatment adherence. Timepoint: Before the intervention, immediately after the intervention, and one month after the intervention. Method of measurement: Modanloo Treatment Adherence Questionnaire. Bandare-abbas University of Medical Sciences Approved 2026-02-15 Research Ethics Committee of Bandar Abbas University of Medical Sciences Chamran Clinic, Chamran Town, opposite the IRIB Broadcasting Center Bandar Abbas Hormozgan Iran (Islamic Republic of)