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IRCT20211103052955N1 IRCT 2021-11-19 Ahvaz University of Medical Sciences Evaluation of the effect of self-management program based on 5 A's model on the quality of life on hemodialysis patients Evaluation of the effect of self-management program based on 5 A's model (Assess, Advise, Agree, Assist, Arrange) on the quality of life on hemodialysis patients 2021-11-22 anticipated 60 Complete https://irct.ir/trial/59799 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Samples by random blocking method with 4 blocks in the form of 6 different modes and using It will be determined from the table of random numbers of the software. Blocking and allocation sequence, It will be done by a statistician in such a way that 6 different modes will be created for 4 blocks. Then, based on the obtained blocks and the sequence of random allocation, patients will be placed in two experimental and control groups. Blinding will not occur in this study. N/A Hemodialysis. Intervention 1: Intervention group: Intervention group: The first step of the evaluation stage: In this stage, the patient is examined for risk factors, disease history, kidney problems, adherence to medication, sleep status, nutrition, activity and information in the file through face-to-face interview. The second step of the guidance stage: In this stage, according to the results of the previous stage, the identified health risks will be informed to the patient and the benefits of behavior change will be emphasized. Step 3: Agree with the patient in realistically setting goals: An agreement is reached between the patient and the researcher about the patient's performance. According to the identified problems, appropriate and agreed behavioral goals with the patient will be determined and for each goal, a practical plan will be designed. For each behavioral goal, a standard requirement of zero to 10 is identified. These items will be recorded on the Behavioral Goals Form and patients will be asked to record their performance status for each Behavioral Goal on a weekly basis for 12 weeks. The fourth step in helping to develop a practical plan: training such as how to control fluid intake, how to care for vascular access, the importance of exercise and physical activity, skin care, diet and medication, etc. face to face Patients will be asked to perform these exercises daily and record their performance. In addition, according to the needs of patients, an individual training session will be arranged according to the patient's wishes in person or by phone in order to repeat and emphasize the items taught to patients. Step 5 Performance follow-up: At this stage, patients' performance will be followed for three months. In fact, to ensure the implementation of practical programs by patients in the first four weeks by phone or text message 3 times a week and from the fifth to the twelfth week, once a week until the end of the intervention, follow-up is done, to do Remind the practical plan and solve possible problems of patients. In addition, the patient's progress will be monitored in a face-to-face session every four weeks. In this meeting, the agreed action plan and behavioral goals will be reviewed, so that if there is a need to change the goals or action plan, the necessary changes will be made by re-agreeing, strengthening and encouraging the continuation of the intervention. Intervention 2: Control group: In the control group other than routine Unit interventions; They will not receive any further intervention. Yes - There is a plan to make this available What will be shared: Some similar information related to the main message or the like can be shared When: Immediately after the final publication of the article, it is possible to access the protocol and findings of the article To whom: Access is available to everyone Conditions: The use of methodology and tools is unrestricted Where to obtain: Refer to the Co-Responsive author of the article for Received any information How to obtain: Email the responsive author to receive any information Comments:
public Sahar Keivan
Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology،Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 6314748679 +98 61 3336 2414 Keivan.s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Sahar Keivan
Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology،Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 1474867963 +98 61 3336 2414 Keivan.s@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Literacy of reading and writing Willingness to participate in the study No history of mental health problems Age range 18 to 65 years 18 years 65 years Both Existence of other underlying diseases such as diabetes, heart disease, cancer Cognitive impairment such as Alzheimer's and amnesia Lifestyle Lifestyle Intervention group: Intervention group: The first step of the evaluation stage: In this stage, the patient is examined for risk factors, disease history, kidney problems, adherence to medication, sleep status, nutrition, activity and information in the file through face-to-face interview. The second step of the guidance stage: In this stage, according to the results of the previous stage, the identified health risks will be informed to the patient and the benefits of behavior change will be emphasized. Step 3: Agree with the patient in realistically setting goals: An agreement is reached between the patient and the researcher about the patient's performance. According to the identified problems, appropriate and agreed behavioral goals with the patient will be determined and for each goal, a practical plan will be designed. For each behavioral goal, a standard requirement of zero to 10 is identified. These items will be recorded on the Behavioral Goals Form and patients will be asked to record their performance status for each Behavioral Goal on a weekly basis for 12 weeks. The fourth step in helping to develop a practical plan: training such as how to control fluid intake, how to care for vascular access, the importance of exercise and physical activity, skin care, diet and medication, etc. face to face Patients will be asked to perform these exercises daily and record their performance. In addition, according to the needs of patients, an individual training session will be arranged according to the patient's wishes in person or by phone in order to repeat and emphasize the items taught to patients. Step 5 Performance follow-up: At this stage, patients' performance will be followed for three months. In fact, to ensure the implementation of practical programs by patients in the first four weeks by phone or text message 3 times a week and from the fifth to the twelfth week, once a week until the end of the intervention, follow-up is done, to do Remind the practical plan and solve possible problems of patients. In addition, the patient's progress will be monitored in a face-to-face session every four weeks. In this meeting, the agreed action plan and behavioral goals will be reviewed, so that if there is a need to change the goals or action plan, the necessary changes will be made by re-agreeing, strengthening and encouraging the continuation of the intervention. Control group: In the control group other than routine Unit interventions; They will not receive any further intervention Quality of life dimension scores before and after the implementation of Model 5A between the intervention and control groups in patients. Timepoint: Before the intervention and three months after the start of the intervention in both groups. Method of measurement: Using Kidney Patients Quality of Life Questionnaire (KDQOL-SF). Ahvaz University of Medical Sciences Approved 2021-10-31 Ethics committee of Ahwaz Jundishapur University of Medical Sciences Ahwaz Jundishapur University of Medical Sciences; Golestan Street., Golestan Blvd., Ahvaz Town Ahvaz Khouzestan Iran (Islamic Republic of)