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IRCT20260721070283N1 IRCT 2026-08-20 Shahid Beheshti University of Medical Sciences Peer‑Support–Based Education in Hemodialysis Patients The Effect of Peer‑Support–Based Education on Self‑Management and eHealth Literacy of Hemodialysis Patients: A Randomized Clinical Trial 2026-08-01 anticipated 70 Recruiting https://irct.ir/trial/91829 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After confirming eligibility criteria, obtaining written informed consent, and completing the baseline assessment, participants will be randomly assigned to the intervention or control group with a 1:1 allocation ratio. Randomization will be performed using permuted blocks with variable block sizes of 4 and 6. The random allocation sequence will be generated by an independent statistician who is not involved in participant recruitment or study implementation, using the R statistical software. The unit of randomization is the individual participant. To ensure allocation concealment, the randomization sequence will be placed in sequentially numbered, opaque, sealed envelopes. Following enrollment and completion of the baseline assessment, the corresponding envelope will be opened sequentially by the researcher, and participants will be assigned to either the intervention or control group according to the predetermined randomization sequence. N/A Self-Management and Health Literacy in Hemodialysis Patients. Intervention 1: Intervention Group: Participants in the intervention group will receive a four-week peer-based education and support program in addition to the usual care provided at the hemodialysis center. The intervention is designed to enhance self-management, increase patients’ knowledge about kidney disease and hemodialysis, strengthen self-care skills, and support patients in managing their disease in daily life.Selection and Training of Peer Supporters: Initially, five peer supporters will be selected from among patients with kidney disease who are undergoing hemodialysis. The selection criteria will include a successful history of disease management, adequate self-management skills, appropriate communication skills, at least a high school diploma, and approval by the research team. In addition, the final selection of peer supporters will be made after obtaining the opinions and approval of the nephrologist, the head nurse, and the nurses working in the hemodialysis unit. Based on their professional knowledge and direct experience with the patients, these healthcare professionals will assess the candidates’ suitability in terms of communication skills, responsibility, cooperation with the healthcare team, and ability to fulfill the peer-support role.Before the intervention begins, the selected peer supporters will receive four face-to-face training sessions, each lasting 90 minutes, delivered once weekly, for a total of six hours. The training program will be developed based on the latest relevant Ministry of Health guidelines, established nephrology guidelines, and relevant scientific sources. The content will be reviewed and approved by a nephrologist before implementation.The peer-supporter training program will consist of two main components:A) Disease-specific and self-care educationThis component will cover an introduction to chronic kidney disease and the hemodialysis process; principles of dietary management and fluid restriction; correct and regular medication use; vascular access care; physical activity appropriate to the patient’s condition; prevention and management of common hemodialysis-related complications; principles of self-management; treatment adherence; and the importance of regular follow-up care.B) Training in peer-support skillsThis component will cover the principles of peer support; the roles and responsibilities of peer supporters; effective communication skills; active listening; empathy; patient education; facilitation of group discussions; responding to patients’ questions within the peer supporter’s scope of competence; motivation for self-care; problem-solving; maintaining patient confidentiality; appropriate referral of questions and problems beyond the peer supporter’s scope of competence to the healthcare team; and introduction to reliable health information resources and principles of appropriate use of electronic health resources to promote patients’ eHealth literacy.Peer supporters will be trained using a variety of educational methods, including brief lectures, group discussions, question-and-answer sessions, role-playing, video presentations, podcasts, and other multimedia educational materials. Role-playing and group discussions will be used to practice communication skills, active listening, empathy, patient education, and management of potential situations that may arise during interactions with patients.To reinforce learning and facilitate continuous review of the training materials, the educational content presented during the face-to-face sessions, including educational files, summaries, and multimedia materials, will also be made available to the peer supporters through a dedicated channel on the Bale messaging platform. This channel will be used for reviewing educational materials, providing information about the intervention schedule, sending reminders, and providing supplementary educational content.Delivery of the Intervention by Peer SupportersFollowing completion of the peer-supporter training program, each peer supporter will be responsible for providing education and support to seven patients, and this support will continue for four weeks. The intervention will be delivered sequentially according to the predetermined educational content, with the materials provided progressively throughout the four-week period in accordance with the planned sequence of the educational program. The educational content will be delivered in four consecutive stages, with one major component of the program presented and reviewed each week according to the sequence specified in the study protocol. At the end of each stage, sufficient opportunity will be provided for questions and answers, clarification of uncertainties, and review of previously presented materials.Peer support will be initiated face-to-face during the patients’ hemodialysis sessions and will continue between hemodialysis sessions through a dedicated channel on the Bale messaging platform. Face-to-face education and support sessions will be conducted during the patients’ scheduled hemodialysis sessions and according to their individual dialysis schedules. During each session, a designated period will be allocated for delivery of the relevant educational content and responding to patients’ questions. During the face-to-face interactions, peer supporters will deliver the content corresponding to each stage and support patients in identifying and addressing problems related to self-care and disease self-management. These interactions will involve individual conversations, question-and-answer sessions, and group discussions, according to patients’ needs.The educational content provided to patients will include chronic kidney disease and hemodialysis, self-care, dietary management and fluid restriction, appropriate medication use, vascular access care, physical activity, prevention and management of common complications, treatment adherence, and other topics related to disease self-management. The content of each stage, including educational materials, multimedia files, summaries, and relevant reminders, will also be made available to patients through the Bale channel. This channel will be used to maintain continuity of education and support, review educational materials, and respond to questions related to the educational content.Using active listening, empathy, motivational support, and problem-solving skills, peer supporters will encourage patients to actively participate in their self-care and adhere to recommendations related to disease management. Emotional and informational support will also be provided within the framework of the training received and within the defined scope of the peer-supporter role. If a patient raises a question or encounters a problem that falls outside the peer supporter’s knowledge or scope of competence, the peer supporter will refrain from providing an independent response or recommendation and will refer the issue to the research/clinical care team. Peer supporters will not be permitted to diagnose medical conditions, provide independent medical advice, modify the type or dosage of medications, or perform any therapeutic intervention. The intervention will not involve the prescription of any new medication or therapeutic substance or any modification of patients’ medication regimens; patients’ pharmacological treatment will continue according to usual care and the instructions of the healthcare team. To ensure that the intervention is delivered in accordance with the study protocol, the researcher will monitor the delivery of the educational program, the sequence of educational content, the quality of interactions between peer supporters and patients, and adherence to the defined scope of the peer-supporter role throughout the four-week intervention period. In addition, peer supporters’ adherence to the educational content and the predefined framework for intervention delivery will be regularly assessed, and guidance will be provided by the researcher if any deviation from the protocol is identified. Intervention 2: Control group: Control GroupParticipants in the control group will receive usual care and routine education provided at the hemodialysis center throughout the study period, according to the center’s standard practice, and will not receive any peer-based education or support from the research team. After completion of the study period and the final assessments, the educational content and materials used in the peer-based education and support program will also be made available to participants in the control group. Yes - There is a plan to make this available What will be shared: De-identified individual participant data (IPD), the final study protocol, the statistical analysis plan (SAP), and the informed consent form. All participant identifiers will be removed before data sharing. The shared dataset will include demographic variables, primary and secondary outcome data, the final study protocol, the statistical analysis plan, and the final informed consent form. When: The data and study documents will be available 6 months after publication of the primary study results and will remain available for at least 5 years. To whom: Researchers, faculty members, graduate students, and other investigators affiliated with academic or research institutions who submit a scientifically justified request. Conditions: The data and study documents may be used solely for scientific research purposes, including secondary analyses, systematic reviews, meta-analyses, or validation of the study findings. Applicants must submit a written request, agree to maintain data confidentiality, and use the data only for the approved research purposes. Any attempt to identify participants or use the data for commercial purposes will not be permitted. Where to obtain: Requests should be submitted to the Principal Investigator. Contact information will be available through the corresponding author of the published article and the institutional affiliation at Shahid Beheshti University of Medical Sciences. How to obtain: Applicants must submit a written request describing the research objectives and the proposed use of the data. The request will be reviewed by the research team. Upon approval and compliance with ethical and confidentiality requirements, the requested data and study documents will be provided within 30 days. Comments:
public Fatemeh Estebsari
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali-e Asr St., Intersection of Ayatollah Hashemi Rafsanjani Expressway, Opposite Shahid Rajaei Heart Center, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 Fa.estebsari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Fatemeh Estebsari
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali-e Asr St., Intersection of Ayatollah Hashemi Rafsanjani Expressway, Opposite Shahid Rajaei Heart Center, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 Fa.estebsari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Have been receiving maintenance hemodialysis for more than 6 months. Be 18 years of age or older. Undergo hemodialysis at least three times per week, with each session lasting a minimum of 3 hours. Be residents of Tehran. Have no known diagnosed psychiatric disorders. Have no speech or hearing impairments that could interfere with participation in the study. Have access to a smartphone. Have not received any hemodialysis-related educational intervention other than the routine education provided by the dialysis center. 18 years no limit Both N18.6 End stage renal disease Behavior Behavior Intervention Group: Participants in the intervention group will receive a four-week peer-based education and support program in addition to the usual care provided at the hemodialysis center. The intervention is designed to enhance self-management, increase patients’ knowledge about kidney disease and hemodialysis, strengthen self-care skills, and support patients in managing their disease in daily life.Selection and Training of Peer Supporters: Initially, five peer supporters will be selected from among patients with kidney disease who are undergoing hemodialysis. The selection criteria will include a successful history of disease management, adequate self-management skills, appropriate communication skills, at least a high school diploma, and approval by the research team. In addition, the final selection of peer supporters will be made after obtaining the opinions and approval of the nephrologist, the head nurse, and the nurses working in the hemodialysis unit. Based on their professional knowledge and direct experience with the patients, these healthcare professionals will assess the candidates’ suitability in terms of communication skills, responsibility, cooperation with the healthcare team, and ability to fulfill the peer-support role.Before the intervention begins, the selected peer supporters will receive four face-to-face training sessions, each lasting 90 minutes, delivered once weekly, for a total of six hours. The training program will be developed based on the latest relevant Ministry of Health guidelines, established nephrology guidelines, and relevant scientific sources. The content will be reviewed and approved by a nephrologist before implementation.The peer-supporter training program will consist of two main components:A) Disease-specific and self-care educationThis component will cover an introduction to chronic kidney disease and the hemodialysis process; principles of dietary management and fluid restriction; correct and regular medication use; vascular access care; physical activity appropriate to the patient’s condition; prevention and management of common hemodialysis-related complications; principles of self-management; treatment adherence; and the importance of regular follow-up care.B) Training in peer-support skillsThis component will cover the principles of peer support; the roles and responsibilities of peer supporters; effective communication skills; active listening; empathy; patient education; facilitation of group discussions; responding to patients’ questions within the peer supporter’s scope of competence; motivation for self-care; problem-solving; maintaining patient confidentiality; appropriate referral of questions and problems beyond the peer supporter’s scope of competence to the healthcare team; and introduction to reliable health information resources and principles of appropriate use of electronic health resources to promote patients’ eHealth literacy.Peer supporters will be trained using a variety of educational methods, including brief lectures, group discussions, question-and-answer sessions, role-playing, video presentations, podcasts, and other multimedia educational materials. Role-playing and group discussions will be used to practice communication skills, active listening, empathy, patient education, and management of potential situations that may arise during interactions with patients.To reinforce learning and facilitate continuous review of the training materials, the educational content presented during the face-to-face sessions, including educational files, summaries, and multimedia materials, will also be made available to the peer supporters through a dedicated channel on the Bale messaging platform. This channel will be used for reviewing educational materials, providing information about the intervention schedule, sending reminders, and providing supplementary educational content.Delivery of the Intervention by Peer SupportersFollowing completion of the peer-supporter training program, each peer supporter will be responsible for providing education and support to seven patients, and this support will continue for four weeks. The intervention will be delivered sequentially according to the predetermined educational content, with the materials provided progressively throughout the four-week period in accordance with the planned sequence of the educational program. The educational content will be delivered in four consecutive stages, with one major component of the program presented and reviewed each week according to the sequence specified in the study protocol. At the end of each stage, sufficient opportunity will be provided for questions and answers, clarification of uncertainties, and review of previously presented materials.Peer support will be initiated face-to-face during the patients’ hemodialysis sessions and will continue between hemodialysis sessions through a dedicated channel on the Bale messaging platform. Face-to-face education and support sessions will be conducted during the patients’ scheduled hemodialysis sessions and according to their individual dialysis schedules. During each session, a designated period will be allocated for delivery of the relevant educational content and responding to patients’ questions. During the face-to-face interactions, peer supporters will deliver the content corresponding to each stage and support patients in identifying and addressing problems related to self-care and disease self-management. These interactions will involve individual conversations, question-and-answer sessions, and group discussions, according to patients’ needs.The educational content provided to patients will include chronic kidney disease and hemodialysis, self-care, dietary management and fluid restriction, appropriate medication use, vascular access care, physical activity, prevention and management of common complications, treatment adherence, and other topics related to disease self-management. The content of each stage, including educational materials, multimedia files, summaries, and relevant reminders, will also be made available to patients through the Bale channel. This channel will be used to maintain continuity of education and support, review educational materials, and respond to questions related to the educational content.Using active listening, empathy, motivational support, and problem-solving skills, peer supporters will encourage patients to actively participate in their self-care and adhere to recommendations related to disease management. Emotional and informational support will also be provided within the framework of the training received and within the defined scope of the peer-supporter role. If a patient raises a question or encounters a problem that falls outside the peer supporter’s knowledge or scope of competence, the peer supporter will refrain from providing an independent response or recommendation and will refer the issue to the research/clinical care team. Peer supporters will not be permitted to diagnose medical conditions, provide independent medical advice, modify the type or dosage of medications, or perform any therapeutic intervention. The intervention will not involve the prescription of any new medication or therapeutic substance or any modification of patients’ medication regimens; patients’ pharmacological treatment will continue according to usual care and the instructions of the healthcare team. To ensure that the intervention is delivered in accordance with the study protocol, the researcher will monitor the delivery of the educational program, the sequence of educational content, the quality of interactions between peer supporters and patients, and adherence to the defined scope of the peer-supporter role throughout the four-week intervention period. In addition, peer supporters’ adherence to the educational content and the predefined framework for intervention delivery will be regularly assessed, and guidance will be provided by the researcher if any deviation from the protocol is identified. Control group: Control GroupParticipants in the control group will receive usual care and routine education provided at the hemodialysis center throughout the study period, according to the center’s standard practice, and will not receive any peer-based education or support from the research team. After completion of the study period and the final assessments, the educational content and materials used in the peer-based education and support program will also be made available to participants in the control group. Self‑Management. Timepoint: Before the intervention, immediately after the intervention, and 3 months after the intervention. Method of measurement: Hemodialysis Self-Management Instrument (HDSMI-18). EHealth Literacy. Timepoint: Before the intervention, immediately after the intervention, and 3 months after the intervention. Method of measurement: eHealth Literacy Scale (eHEALS). Shahid Beheshti University of Medical Sciences Approved 2026-02-16 Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali-e Asr St., Intersection of Ayatollah Hashemi Rafsanjani Expressway, Opposite Shahid Rajaei Heart Center, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)