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IRCT20251109067926N1 IRCT 2025-12-30 Shiraz University of Medical Sciences Effect of Mobile-Based Self-Care Training in Hemodialysis Patients Investigation of the Effect of Mobile-Based Self-Care Training on Fatigue, Symptom Burden, and Self-Management in Hemodialysis Patients 2026-01-21 anticipated 88 Complete https://irct.ir/trial/88009 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: A randomized controlled clinical trial with parallel groups, single-blind, Randomization description: Participants will be enrolled in the study based on a random number table. They will then be assigned to the intervention and control groups using permuted random blocks of size four. The list of random blocks will be generated by a statistician using specialized software, and the finalized block list will be placed in sealed, numbered envelopes by the statistician. This procedure ensures an equal number of participants in both groups. After selecting each patient for allocation, the envelopes will be opened sequentially, and participants will be assigned to either the intervention or control group based on the content of the envelope. This process will continue until all envelopes have been opened and the study is completed, Blinding description: In this study, blinding will be conducted such that the research assistant responsible for data collection and the statistician performing data analysis will remain blinded to the group assignments until the end of the study. N/A End stage Chronic kidney disease. Intervention 1: Intervention group: Intervention Group: In the experimental group, the intervention will consist of mobile-based self-care education. This program is structured according to the Self-Care Matrix theory across four main domains: activities, behaviors, context, and environment.Session 1: Participants will receive instructions on how to engage with the program through audio messages and video clips shared in the selected social media group.Sessions 2–5: Focusing on the context and environment domains of the Matrix theory, education will cover the importance of social support, group communication, and support from family, friends, peers, and individuals with similar conditions, as well as support from the healthcare team, including nurses, for patients undergoing hemodialysis. Guidance will also be provided on collaborating with and participating in care alongside the family and healthcare team. Additionally, the role of self-care in hemodialysis patients will be demonstrated through short educational videos.Session 6: A brief introduction to kidney anatomy and physiology will be provided to enhance understanding of the subsequent educational content.Sessions 7–28: Based on the behavior and activity domains of the Matrix theory, content will include understanding kidney failure and its symptoms, familiarity with hemodialysis and its treatment approach, recognition of complications and symptoms related to hemodialysis, the importance of medication adherence, dietary management, and fistula care. Education on stress and anxiety management, including effective relaxation techniques, will also be provided.Final Sessions: The last two sessions will focus on spiritual communication to promote calmness and positive thinking, including strategies such as prayer, seeking intercession from the Ahl al-Bayt, and guidance on religious beliefs with encouragement for positive thinking.The self-care education will be delivered daily for one month through one of the social media platforms accepted by all participants, in the form of short video clips provided as dedicated links via the PorsLine platform. The intervention will be presented using MP4 files in a micro-teaching format. Audio narration and editing of the content will be done using Camtasia software. The final MP4 files (video and audio) will first be uploaded to the PorsLine website to ensure participants view the short videos, and then access links for each session will be shared in the selected social media group according to the scheduled program. Intervention 2: Control group: Control Group: Participants in the control group will receive the standard care provided at the hemodialysis center. This care includes connection to the dialysis machine and routine nursing care, such as machine adjustments, blood pressure monitoring, and other standard procedures conducted during regular hemodialysis sessions. After the completion of the study, the educational content provided to the experimental group will be shared with the control group as short daily video clips. Yes - There is a plan to make this available What will be shared: The primary outcomes of the study are shareable. When: The access period begins 6 months after publication of the article. To whom: Individuals and researchers at academic institutions Conditions: The information is provided for informational purposes only. Where to obtain: The data are accessible via email at rambodma@gmail.com How to obtain: The data are accessible via email at rambodma@gmail.com Comments:
public Masoume Rambod
Shiraz, Zand Street, Namazi Square, School of Nursing and Midwifery, Shiraz
Shiraz Iran (Islamic Republic of) 71936–13119 +98 71 3677 4254 rambodma@gmail.com Shiraz University of Medical Sciences scientific Masoume Rambod
Shiraz, Zand Street, Namazi Square, School of Nursing and Midwifery, Shiraz
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4258 rambodma@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Being 18 years of age or older Having completed at least 6 months since the initiation of hemodialysis Able to understand and speak the Persian language Having active access to a smartphone and the Internet, and the ability to use social media Undergoing hemodialysis three times per week Being at least basic literacy (reading and writing skills) to understand the educational content A definitive diagnosis of chronic kidney disease confirmed by a nephrologist Not participating concurrently in other hemodialysis-related educational programs 18 years no limit Both Undergoing kidney transplantation Failure to view three consecutive sessions of the provided educational content Having an acute myocardial infarction and being on mechanical ventilation at the time of the study Lack of willingness on the part of the patient to continue cooperating with the researcher during the study Presence of a chronic psychiatric disorder diagnosed by a physician Hospitalization of the patient N18.5 Chronic kidney disease, stage 5 Rehabilitation N/A Intervention group: Intervention Group: In the experimental group, the intervention will consist of mobile-based self-care education. This program is structured according to the Self-Care Matrix theory across four main domains: activities, behaviors, context, and environment.Session 1: Participants will receive instructions on how to engage with the program through audio messages and video clips shared in the selected social media group.Sessions 2–5: Focusing on the context and environment domains of the Matrix theory, education will cover the importance of social support, group communication, and support from family, friends, peers, and individuals with similar conditions, as well as support from the healthcare team, including nurses, for patients undergoing hemodialysis. Guidance will also be provided on collaborating with and participating in care alongside the family and healthcare team. Additionally, the role of self-care in hemodialysis patients will be demonstrated through short educational videos.Session 6: A brief introduction to kidney anatomy and physiology will be provided to enhance understanding of the subsequent educational content.Sessions 7–28: Based on the behavior and activity domains of the Matrix theory, content will include understanding kidney failure and its symptoms, familiarity with hemodialysis and its treatment approach, recognition of complications and symptoms related to hemodialysis, the importance of medication adherence, dietary management, and fistula care. Education on stress and anxiety management, including effective relaxation techniques, will also be provided.Final Sessions: The last two sessions will focus on spiritual communication to promote calmness and positive thinking, including strategies such as prayer, seeking intercession from the Ahl al-Bayt, and guidance on religious beliefs with encouragement for positive thinking.The self-care education will be delivered daily for one month through one of the social media platforms accepted by all participants, in the form of short video clips provided as dedicated links via the PorsLine platform. The intervention will be presented using MP4 files in a micro-teaching format. Audio narration and editing of the content will be done using Camtasia software. The final MP4 files (video and audio) will first be uploaded to the PorsLine website to ensure participants view the short videos, and then access links for each session will be shared in the selected social media group according to the scheduled program. Control group: Control Group: Participants in the control group will receive the standard care provided at the hemodialysis center. This care includes connection to the dialysis machine and routine nursing care, such as machine adjustments, blood pressure monitoring, and other standard procedures conducted during regular hemodialysis sessions. After the completion of the study, the educational content provided to the experimental group will be shared with the control group as short daily video clips. Fatigue. Timepoint: Before the intervention and 30 days after its initiation (after the completion of the intervention). Method of measurement: Post dialysis fatigue scale ( PDFs). Symptom Burden. Timepoint: Before the intervention and 30 days after its initiation (after the completion of the intervention). Method of measurement: Dialysis Symptom Index (DSI). Self-Management. Timepoint: Before the intervention and 30 days after its initiation (after the completion of the intervention). Method of measurement: Hemodialysis self-management instrument(HD-SMI). Shiraz University of Medical Sciences Approved 2025-11-15 Research Ethics Committee of the Schools of Nursing and Midwifery, Medical Management and Informatio Zand Street, next to the Red Crescent, Central Building of Shiraz University of Medical Sciences, 7th Floor, Research Deputy Office Shiraz Fars Iran (Islamic Republic of)