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IRCT20090522001930N4 IRCT 2021-11-12 Boushehr University of Medical Sciences the effect of health-promoting behaviors training in both caregiver-centered and patient-centered methods on the care burden of informal caregivers and adherence the treatment of patients undergoing hemodialysis Comparison of the effect of health-promoting behaviors training in both caregiver-centered and patient-centered methods on the care burden of informal caregivers and adherence the treatment of patients undergoing hemodialysis 2021-11-22 anticipated 248 Complete https://irct.ir/trial/57773 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: the aim of this study was to determine and compare the effect of teaching health promoting behaviors in both caregiver centered and patient centered methods on the care burden of informal caregivers and adherence the treatment of hemodialysis patient referred to hemodialysis centers in bushehr and borazjan is planned in 2021. and samples are randomly assigned to four group(A,B,C,D). so that group A only patient participate in it and only patients receive patient centered education. in group B ,only caregivers participate and only caregiver receive caregiver centered education. group C include both the patient and primary caregiver couples, and participants in this group receive patient centered and caregiver centered training. and the control group D does not receive any training and only receives routine training of hemodialysis centers. this study is a randomized controlled trial with follow up. so that pre test will be taken from all 4 group and then immediately and 4 weeks(following) after the educational intervention , the questionnaires will be completed again by the samples participating in the study in all 4 group of interventional and control, Randomization description: the samples( sick and caring couple) will be selected based on the purpose and considering the inclusion criteria and then will be assigned to 4 groups to match the groups by random block allocation. 15 blocks of 8 and one block 4 will be used. N/A End stage renal disease. Intervention 1: Intervention group: Intervention A: only patients are included in this group, and initially by obtain a pre-test before the intervention and continue to holding training sessions using teach- back method for patients during 7 sessions and also create a whats app group to provide educational videos for patient and taking post- test immediately after intervention and one months later(following). Intervention 2: Intervention group: Intervention B: only caregivers are included in this group, and initially by obtain a pre-test before the intervention and continue to holding training sessions using teach- back method for primary caregiver during 7 sessions and also create a whats app group to provide educational videos for primary caregiver and taking post-test immediately after intervention and one months later(following). Intervention 3: Intervention group: Intervention C: in this group the patient and caregivers placed and initially by obtain a pre- test before the intervention and continue to holding training sessions using teach - back method for patient and their primary caregivers during 7 sessions and also create a common whats app group to provide educational videos for patient and their primary caregiver and taking post - test immediately after intervention and one months later(following). Intervention 4: Intervention group: Control group D: in the control group , no training is given to the patient and caregiver. It has a pre-test but not training sessions and whats app group formation and taking post-test immediately after intervention and one months later(following). 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 There is no program for its release
public Hakimeh Vahedparast
University of Medical Sciences, Faculty of Nursing and Midwifery, Bushehr.
Bushehr Iran (Islamic Republic of) 7518759577 +98 77 3345 0236 h.vahedparast@bpums.ac.ir Boushehr University of Medical Sciences scientific Hakimeh Vahedparast
University of Medical Sciences, Faculty of Nursing and Midwifery, Bushehr.
Bushehr Iran (Islamic Republic of) 7518759577 +98 77 3345 0236 h.vahedparast@bpums.ac.ir Boushehr University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) have been on hemodialysis for at least 6 months do not need temporary hemodialysis (poisoning- acute renal failure- guest) patients must be over 18 years old and up to 70 years old have the consent to participate in the study be at least literate have a smartphone the patient has access to the internet be responsible for the care of hemodialysis patients( based on self- declaration) be at least 18 years old. informal caregiver has access to the internet 18 years 70 years Both the patient dies during the intervention be known to have cognitive and mental disorder one of the couples should not participate in the study have serious physical problems while studying so that loses the ability to care for the patient. give the person a break from continuing to work with the research team while studying. have known neurological and mental disorder( based on the doctors diagnosis) introduced caregiver the patient does not attend two or more sessions. N18.6 Long-standing and persistent renal disease with glomerular filtration rate (gfr) less than 15 ml/min. N/A N/A N/A N/A Intervention group: Intervention A: only patients are included in this group, and initially by obtain a pre-test before the intervention and continue to holding training sessions using teach- back method for patients during 7 sessions and also create a whats app group to provide educational videos for patient and taking post- test immediately after intervention and one months later(following). Intervention group: Intervention B: only caregivers are included in this group, and initially by obtain a pre-test before the intervention and continue to holding training sessions using teach- back method for primary caregiver during 7 sessions and also create a whats app group to provide educational videos for primary caregiver and taking post-test immediately after intervention and one months later(following). Intervention group: Intervention C: in this group the patient and caregivers placed and initially by obtain a pre- test before the intervention and continue to holding training sessions using teach - back method for patient and their primary caregivers during 7 sessions and also create a common whats app group to provide educational videos for patient and their primary caregiver and taking post - test immediately after intervention and one months later(following). Intervention group: Control group D: in the control group , no training is given to the patient and caregiver. It has a pre-test but not training sessions and whats app group formation and taking post-test immediately after intervention and one months later(following). Treatment adherence. Timepoint: pre- test before the intervention and immediately after the test and 4 weeks(following) after the intervention. Method of measurement: the end stage renal disease- adherence questionnaire developed by Youngmee Kim will be used. Caregiver burden. Timepoint: pre-test before the intervention and immediately after the test and 4 weeks(following) after the intervention. Method of measurement: A care burden questionnaire Guest and Novak with a 5 point Likert scale will be used. Bushehr University of Medical Sciences Approved 2021-07-19 Ethics Committee of Bushehr University of Medical Sciences Pardis Site of Bushehr University of Medical of Science, Rishehr St, Bushehr, Iran. Bushehr Boushehr Iran (Islamic Republic of)