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IRCT20220504054737N1 IRCT 2022-07-12 Esfahan University of Medical Sciences Investigating the Effect of Educational Program using Mobile Phone on the hHealth of hHemodialysis Patients Comparison of the Effectiveness of Patient-Caregiver Cognitive-Behavioral Intervention on Promoting Adherence to Treatment Behaviors in Hemodialysis Patients in Isfahan 2023-01-21 anticipated 80 Complete https://irct.ir/trial/63427 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: The current research is a randomized experimental intervention (clinical trial) of pre-test-post-test type with a control group. The sampling method in this research is multi-stage random cluster sampling: The first stage: Isfahan hemodialysis centers are identified, which includes 4 government hemodialysis centers: Al-Zahra, Farabi, Amin, Ali Asghar and 3 private hemodialysis centers: Zahra Marzieh, Hojjatiyeh and Abolfazl. These centers are almost similar to each other in terms of socio-economic characteristics, and each of them includes heterogeneous groups, and these centers can be considered as clusters. The number of 80 samples is required for the study. Then, the number of hemodialysis patients in each center is specified and the number of patients participating in the study will be determined based on the probability proportional to size (PPS) approach. The second step: simple random method with replacement is used to select patients participating in the study. The list of hemodialysis patients of each center is specified and a code is given to each patient. Each code is written on a sheet and placed inside the box, and then we take the papers one by one and write down the names of the patients and put the sheets back into the box, and this process continues until the desired sample volume is complete. This selection is done by lottery, which shows that it is a random sampling. This method will be implemented for all 7 centers to obtain 80 samples. The third step: 80 samples will be allocated in two control groups (40 samples) and intervention (samples) by simple random sampling method. Each sample is given a code and each code is written on a sheet and placed inside the box and the samples are selected by simple random sampling method and the first 40 samples will be placed in the intervention group and the second 40 samples will be placed in the comparison group, Blinding description: In this study, blindness is one-way and the subjects do not know which intervention or control groups they are in. N/A Hemodialysis. Intervention 1: Intervention group: Intervention group: Hemodialysis patients enter the study after describing the study objectives and obtaining consent. In addition to receiving routine hemodialysis care, the intervention team will receive the "Training Program for Chronic Renal Failure and Hemodialysis" application. The researchers then explain to the intervention group how to receive training programs through the application. Also, how to use the application in the form of text and videos will be included in the application. Then the application will be installed on the mobile phone or tablet of the intervention group and how to use it will be explained. The duration of sending training programs is one month and the programs are in 4 sessions (one session every 7 days). ) Is sent to the intervention group through the application. The training programs of each session are divided and sent to the intervention group within seven days (one or more programs per day). Necessary trainings are given to the intervention group before the start of the program and at the beginning of each session through the application. At the end of each session, a simple and short test will be sent to users to measure their learning. Also, reminders for taking medicine and participating in dialysis sessions are embedded in this software that will help patients in managing the disease. Intervention 2: Control group: Hemodialysis patients enter the study after describing the study objectives and obtaining consent. The control group will receive routine hospital training on chronic renal failure and hemodialysis, and no educational intervention will be performed for the control group by the researchers. The control group will receive the application "Educational program related to chronic kidney failure and hemodialysis" after the end of the educational intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of information is one of the important ethical principles of our study
public Ahmadali Eslami
Department of Health Education, School of Health, Isfahan University of Medical Sciences, Shiraz Gate, Isfahan,
Isfahan Iran (Islamic Republic of) 81746-73461 (+98)-31-3723239 eeslami@hlth.mui.ac.ir Esfahan University of Medical Sciences scientific Ahmadali Eslami
Department of Health Education, School of Health, Isfahan University of Medical Sciences, Shiraz Gate, Isfahan,
Isfahan Iran (Islamic Republic of) 81746-73461 (+98)-31-3793239 eeslami@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients receiving Hemodialysis twice a Week or more Patients who have been on Dialysis for at least three Months 18 years no limit Both Patients who are hospitalized due to acute Illness Patients with Mental Illness Patients on the Kidney Transplant list for the next six Months Other Other Intervention group: Intervention group: Hemodialysis patients enter the study after describing the study objectives and obtaining consent. In addition to receiving routine hemodialysis care, the intervention team will receive the "Training Program for Chronic Renal Failure and Hemodialysis" application. The researchers then explain to the intervention group how to receive training programs through the application. Also, how to use the application in the form of text and videos will be included in the application. Then the application will be installed on the mobile phone or tablet of the intervention group and how to use it will be explained. The duration of sending training programs is one month and the programs are in 4 sessions (one session every 7 days). ) Is sent to the intervention group through the application. The training programs of each session are divided and sent to the intervention group within seven days (one or more programs per day). Necessary trainings are given to the intervention group before the start of the program and at the beginning of each session through the application. At the end of each session, a simple and short test will be sent to users to measure their learning. Also, reminders for taking medicine and participating in dialysis sessions are embedded in this software that will help patients in managing the disease. Control group: Hemodialysis patients enter the study after describing the study objectives and obtaining consent. The control group will receive routine hospital training on chronic renal failure and hemodialysis, and no educational intervention will be performed for the control group by the researchers. The control group will receive the application "Educational program related to chronic kidney failure and hemodialysis" after the end of the educational intervention Adherence to diet. Timepoint: Outcome variable is measured in three stages: before the intervention, one month and three months after the end of the educational intervention. Method of measurement: End-Stage Renal Disease - Adherence Questionnaire (ESRD-AQ). Compliance with fluid restrictions. Timepoint: Outcome variable is measured in three stages: before the intervention, one month and three months after the end of the educational intervention. Method of measurement: End-Stage Renal Disease - Adherence Questionnaire (ESRD-AQ). Adherence to prescription drugs. Timepoint: Outcome variable is measured in three stages: before the intervention, one month and three months after the end of the educational intervention. Method of measurement: End-Stage Renal Disease - Adherence Questionnaire (ESRD-AQ). Regular attendance at hemodialysis sessions. Timepoint: Outcome variable is measured in three stages: before the intervention, one month and three months after the end of the educational intervention. Method of measurement: End-Stage Renal Disease - Adherence Questionnaire (ESRD-AQ). Esfahan University of Medical Sciences Approved 2022-04-30 Research Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St., Shiraz Gate, Isfahan Isfahan Isfehan Iran (Islamic Republic of)