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

Determining the Effect of Education Based on Leventhal's Self-Regulation Model on Resilience and Treatment Adherence in Patients Undergoing Hemodialysis

A single-blind, parallel-group, randomized controlled clinical trial was conducted. A total of 102 patients were enrolled in the study. Participants were randomly allocated to the intervention and control groups using Random Allocation Software (RAS) through permuted block randomization, consisting of 26 blocks of four participants each.

This quasi-experimental study will include patients undergoing hemodialysis at the Payambar Azam Educational, Research, and Therapeutic Center in Bandar Abbas, Iran (2026–2027). Eligible participants will be recruited through consecutive convenience sampling and randomly assigned to the intervention or control group. Following ethics approval, written informed consent will be obtained. Participation will be voluntary, confidentiality will be maintained, and participants may withdraw at any time. At baseline, all participants will complete a demographic form and the study questionnaires.

Inclusion Criteria Age 18–65 years. Literate and questionnaire completion ability. No cognitive or psychiatric disorders. Effective communication ability. Social media application proficiency. Written informed consent provided. Exclusion Criteria Withdrawal from the study. Hospitalization during the study. Previous educational intervention participation. Death during the study.

intervention group: Patients undergoing hemodialysis who receive an educational intervention based on Leventhal's Self-Regulation Model. Control group: These patients will receive the routine care provided by the hemodialysis unit.

Resilience; adherence to treatment

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 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.