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IRCT20221231057000N2 IRCT 2023-12-11 Shahroud University of Medical Sciences The Effect of Empowerment Based on 5A Model on Fall Self-Efficacy, Self-Care and Quality of Life in Older Adults The Effect of Empowerment Based on 5A Model on Fall Self-Efficacy, Self-Care and Quality of Life in Older Adults: A Parallel Randomized Clinical Trial 2024-01-21 anticipated 110 Complete https://irct.ir/trial/73685 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: A block method with a volume of 4 will be used to create a random allocation sequence because the elderly will gradually enter the study and also to ensure that the number of people assigned to each group is equal. By referring to any health center and finding eligible people and according to the order of their entry into the study, the individual will be assigned to the intervention or control group using the allocation sequence hidden in opaque envelopes. The way to hide the sequence is to use opaque envelopes, which will be prepared in 110 pieces and each sequence is placed inside an opaque envelope and numbered on the envelopes. The random allocation sequence was obtained with the cooperation of the methodological consultant. Example: 1,4,1 group A and 1,4,2 group B. N/A Condition 1: Fall self-efficacy. Condition 2: Self-care. Condition 3: Quality of life. Intervention 1: Intervention group: in this group individual empowerment will be done based on the 5A self-management model. The intervention will be done within 3 months (12 weeks) for each person. The content of the sessions is about falls and self-care. Face-to-face meetings will be in a classroom and non-face-to-face meetings will be through phone calls. Individual empowerment based on the 5A model has 5 steps as follows: 1- The first step is assessment. At this stage, the patient's records and history, including having a history of falls, family history, medications, nutrition, rest and sleep status, co-morbidity, activity, symptoms, risk factors and causes of problems with the help of questionnaires, history forms and evaluation methods, will be assess. 2- The second step is advice. In this step, abnormal cases, problems and risks of health deviation identified from the first step are individually informed to the patients. The risks of not performing self-care, having low self-efficacy of falling and the consequences of not taking the necessary measures to prevent falling and the benefits of changing behavior in preventing complications of falling and fear of falling are informed to the patient. At this stage, the patient is informed about the factors influencing the creation or exacerbation of the fear of falling, its consequences, complications, its nature, and the benefits of performing behaviors to prevent falls and reduce the fear of falling, and the benefits of performing self-care behaviors and improving the quality of life. 3- The third step is agreement, according to the identified problems of the elderly, goals are determined based on the patient's interest and satisfaction, and an operational plan (action) is designed for each of the goals. In order to ensure that the agreed program is carried out by the elderly, he is asked to record his functional status at the end of the study in a self-report form for each of the goals. 4- The fourth step is assist education about falling and fear of falling will be done based on the prepared booklet. During the meeting, the elderly are provided with training such as methods of preventing the risk of falling, the nature, causes, complications and factors affecting falling and fear of falling, and balance maintenance activities. Also, trainings on self-care such as physical self-care (adherence to medication and food regimens, personal hygiene, etc.) are provided to the elderly. Training will be carried out by individual method, questions and answers, presentation of booklets, pamphlets and telephone consultations. 5- The fifth step is arrange. In this step, the previous four steps and the plan agreed with the elderly are reviewed and modified if there are any changes. The follow-up for 3 months will be done in absentia through a phone call or in person if necessary. Intervention 2: Control group: The control group received routine care and counseling. Yes - There is a plan to make this available What will be shared: Still undecided - no release schedule yet When: Still undecided - no release schedule yet To whom: Researchers and students of academic and scientific institutions Conditions: Still undecided - no release schedule yet Where to obtain: ermiamaghsoodloo@gmail.com How to obtain: A clear explanation of why data access is needed Comments:
public Ermia Maghsoodloo
No. 18_ 12 alley _Imam Township _ Gorgan
Gorgan Iran (Islamic Republic of) 4915733589 +98 939 885 8896 ermiamaghsoodloo@gmail.com Shahroud University of Medical Sciences scientific DR. Ali Dadgari
Shahrood University of Medical Sciences and Health Care Services, Haftam Tir Square, Shahroud
Shahroud Iran (Islamic Republic of) ۳۶۱۴۷۷۳۹۴۳ +98 23 3239 5054 Adadgari@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Being 65 years old and above All seniors should be aware of the time, place and person and have the ability to understand educational materials. Having independence in activities of daily living 65 years no limit Both The participant suffering from an known physical or psychiatric disorder. The participant suffering participated in similar educational programs at the same time. The participant is not willing to participate in the study. N/A N/A Intervention group: in this group individual empowerment will be done based on the 5A self-management model. The intervention will be done within 3 months (12 weeks) for each person. The content of the sessions is about falls and self-care. Face-to-face meetings will be in a classroom and non-face-to-face meetings will be through phone calls. Individual empowerment based on the 5A model has 5 steps as follows: 1- The first step is assessment. At this stage, the patient's records and history, including having a history of falls, family history, medications, nutrition, rest and sleep status, co-morbidity, activity, symptoms, risk factors and causes of problems with the help of questionnaires, history forms and evaluation methods, will be assess. 2- The second step is advice. In this step, abnormal cases, problems and risks of health deviation identified from the first step are individually informed to the patients. The risks of not performing self-care, having low self-efficacy of falling and the consequences of not taking the necessary measures to prevent falling and the benefits of changing behavior in preventing complications of falling and fear of falling are informed to the patient. At this stage, the patient is informed about the factors influencing the creation or exacerbation of the fear of falling, its consequences, complications, its nature, and the benefits of performing behaviors to prevent falls and reduce the fear of falling, and the benefits of performing self-care behaviors and improving the quality of life. 3- The third step is agreement, according to the identified problems of the elderly, goals are determined based on the patient's interest and satisfaction, and an operational plan (action) is designed for each of the goals. In order to ensure that the agreed program is carried out by the elderly, he is asked to record his functional status at the end of the study in a self-report form for each of the goals. 4- The fourth step is assist education about falling and fear of falling will be done based on the prepared booklet. During the meeting, the elderly are provided with training such as methods of preventing the risk of falling, the nature, causes, complications and factors affecting falling and fear of falling, and balance maintenance activities. Also, trainings on self-care such as physical self-care (adherence to medication and food regimens, personal hygiene, etc.) are provided to the elderly. Training will be carried out by individual method, questions and answers, presentation of booklets, pamphlets and telephone consultations. 5- The fifth step is arrange. In this step, the previous four steps and the plan agreed with the elderly are reviewed and modified if there are any changes. The follow-up for 3 months will be done in absentia through a phone call or in person if necessary. Control group: The control group received routine care and counseling. Fall self-efficacy score in Activities-specific Balance Confidence Scale. Timepoint: Measuring fall self-efficacy before the start of the intervention and random allocation and after the twelfth week and completion of the intervention. Method of measurement: Activities-specific Balance Confidence Scale questionnaire. Self-care score in the Self-Care Questionnaire for the Elderly. Timepoint: Measuring self-care before the start of the intervention and random allocation and after the twelfth week and completion of the intervention. Method of measurement: Self-Care Questionnaire for the Elderly. Quality of life score in WHO-5 Well-being questionnaire. Timepoint: Measuring Quality of life before the start of the intervention and random allocation and after the twelfth week and completion of the intervention. Method of measurement: WHO-5 Well-being questionnaire. Shahroud University of Medical Sciences Approved 2023-11-28 Ethics committee of Shahroud University of Medical Sciences Shahroud University of Medical Sciences and Health Care Services, Haftam Tir Square, Shahroud Shahroud Semnan Iran (Islamic Republic of)