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IRCT20230208057363N1 IRCT 2023-03-05 Shahid Beheshti University of Medical Sciences Effect of Self Care Empowerment Program on Quality of Life and Functional Independence of the Older Adult Undergoing Hemodialysis Effect of Self Care Empowerment Program on Quality of Life and Functional Independence of the Older Adult Undergoing Hemodialysis 2023-04-04 anticipated 70 Complete https://irct.ir/trial/68737 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance. N/A End–Stage Renal Disease; ESRD. Intervention 1: Intervention group:First, quality of life questionnaire, Barthel index and Lawton index will be provided to the patients, then people with low scores will be selected as samples. The program is supposed to be presented in groups of 3-4 people. The grouping of the participants will be adjusted based on their opinion to participate in empowerment missions (from Saturday to Wednesday every week). Self-care empowerment program by holding 6-8 sessions for the intervention group, each session will be around 60-70 minutes. In this study, the content of the program will be compiled from a combination of two components, for the empowerment component, the BASNEF model will be used, and for the self-care component, the self-care questionnaire of patients with chronic kidney failure will be used for needs assessment. The empowerment program for these patients will include diet training, exercise, ways to prevent and control hemodialysis complications, anxiety control, stress management, and self-care.The training will be held face-to-face, discussion and exchange of ideas and using educational media such as video projector and PowerPoint.In the first to third sessions, the importance of changing wrong behaviors and its effects on health and improving the quality of life (belief structures, attitudes, mental norms) will be mentioned.The second session will be held with the presence of a doctor and nurse, and in the third session, a member of the patient's family who lives with him and plays an essential role in the patient's care will also participate.In addition, for the better effectiveness of the empowerment program, a booklet will be given to the family members of the patients. At the end of each session, homework is given to the patients, which includes the materials taught in the sessions, recording the patient's daily problems, complications of hemodialysis.At the beginning of the next session, homework will be reviewed and feedback will be given. In addition to following up the patient during the sessions, the researcher calls the patient during the week to ensure the correct implementation of the trained behaviors and also to answer the patient's questions. Finally, the questionnaires are completed again by the participants one month after the end of the intervention and the data are reviewed and compared. Intervention 2: Control group: First, quality of life questionnaire, Barthel index and Lawton index will be provided to the patients, then people with low scores will be selected as samples. During the implementation of the research, the control group will not participate in any kind of educational program and will only receive the usual treatment and follow-ups of the center. Finally, the questionnaires are completed again by the participants one month after the end of the intervention and the data are reviewed and compared. 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 Its release schedule is not yet known
public Marzieh Sotoudeh
Vali Asr Ave., Niayesh Cross Road, Niayesh Complex,
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5368 msotoudeh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Roghayeh Esmaeili
Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5368 r.esmaieli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Be 60 years old or older Six months have passed since the start of hemodialysis Not suffering from cognitive disorders (based on the AMTS criteria and scoring at least 7 out of 10) To have the ability to communicate and to be able to complete questionnaires Have the ability to participate in the self-care empowerment program 60 years no limit Both The elderly do not want to continue participating in the research for any reason Do not participate in 2 sessions of the self-care empowerment program Any disturbance in the mental state or consciousness of the elderly I12.0 Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease Behavior Behavior Intervention group:First, quality of life questionnaire, Barthel index and Lawton index will be provided to the patients, then people with low scores will be selected as samples. The program is supposed to be presented in groups of 3-4 people. The grouping of the participants will be adjusted based on their opinion to participate in empowerment missions (from Saturday to Wednesday every week). Self-care empowerment program by holding 6-8 sessions for the intervention group, each session will be around 60-70 minutes. In this study, the content of the program will be compiled from a combination of two components, for the empowerment component, the BASNEF model will be used, and for the self-care component, the self-care questionnaire of patients with chronic kidney failure will be used for needs assessment. The empowerment program for these patients will include diet training, exercise, ways to prevent and control hemodialysis complications, anxiety control, stress management, and self-care.The training will be held face-to-face, discussion and exchange of ideas and using educational media such as video projector and PowerPoint.In the first to third sessions, the importance of changing wrong behaviors and its effects on health and improving the quality of life (belief structures, attitudes, mental norms) will be mentioned.The second session will be held with the presence of a doctor and nurse, and in the third session, a member of the patient's family who lives with him and plays an essential role in the patient's care will also participate.In addition, for the better effectiveness of the empowerment program, a booklet will be given to the family members of the patients. At the end of each session, homework is given to the patients, which includes the materials taught in the sessions, recording the patient's daily problems, complications of hemodialysis.At the beginning of the next session, homework will be reviewed and feedback will be given. In addition to following up the patient during the sessions, the researcher calls the patient during the week to ensure the correct implementation of the trained behaviors and also to answer the patient's questions. Finally, the questionnaires are completed again by the participants one month after the end of the intervention and the data are reviewed and compared. Control group: First, quality of life questionnaire, Barthel index and Lawton index will be provided to the patients, then people with low scores will be selected as samples. During the implementation of the research, the control group will not participate in any kind of educational program and will only receive the usual treatment and follow-ups of the center. Finally, the questionnaires are completed again by the participants one month after the end of the intervention and the data are reviewed and compared. Quality of life score in SF-36 questionnaire. Timepoint: Completing the SF-36 quality of life questionnaire at the beginning of the study (before the start of the intervention) and one month after the end of the intervention. Method of measurement: Quality of life questionnaire SF-36 (36 Item Health Survey SF-36). Functional Independence score in Barthel index (Basic Activities Daily of Living) and Lawton index (Instrumental Activities Daily of Living). Timepoint: Completing the Barthel index and the Lawton index at the beginning of the study (before the start of the intervention) and one month after the end of the intervention. Method of measurement: Barthel index (Basic Activities Daily of Living) and Lawton index (Instrumental Activities Daily of Living). Shahid Beheshti University of Medical Sciences Approved 2022-05-24 Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran. Tehran Tehran Iran (Islamic Republic of)