Protocol summary
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Study aim
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Determining the Effect of the 5A Empowerment Model on Fall Self-efficacy, Self-Care and Quality of Life in Older Adults: A Parallel Randomized Clinical Trial
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Design
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A clinical trial with a control group with parallel groups, randomized by a block method with a volume of 4 is used to create a random allocation sequence because the elderly are gradually included in the study. The sample size is 110 people.
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Settings and conduct
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The research population includes all elderly people over 65 living in Gorgan city. The research environment is the health centers of Gorgan city. The elderly will be selected by sequential sampling. In this way, the city of Gorgan will be classified into three regions one, two and three in terms of municipal divisions and two centers will be randomly selected from each region and a sample will be taken according to the population of the elderly covered by the health centers of that region.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: being 65 years of age and over, understanding educational materials, independence in performing activities in daily life.
Exclusion criteria: physical or psychiatric disorder, participation in similar educational programs at the same time, unwillingness to participate in the study
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Intervention groups
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In the intervention group, the individual program will be conducted based on the 5A self-management model. Each person will receive the intervention within 3 months (12 weeks). 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: Assessment, Advice, Agreement, Assistance, and Arrangement. The control group will receive routine care and counseling.
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Main outcome variables
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Fall self-efficacy, Self-care, Quality of life
General information
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Reason for update
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editing the english translation of title and the fall self-efficacy In the primary outcome variable field. In these parts, fall self-efficacy was translated as falls self-efficacy, which is correct fall self-efficacy.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221231057000N2
Registration date:
2023-12-11, 1402/09/20
Registration timing:
prospective
Last update:
2024-08-23, 1403/06/02
Update count:
1
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Registration date
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2023-12-11, 1402/09/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-01-21, 1402/11/01
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Expected recruitment end date
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2024-09-21, 1403/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The Effect of Empowerment Based on 5A Model on Fall Self-Efficacy, Self-Care and Quality of Life in Older Adults
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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.
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Age
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From 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-28, 1402/09/07
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Ethics committee reference number
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IR.SHMU.REC.1402.137
Health conditions studied
1
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Description of health condition studied
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Fall self-efficacy
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Self-care
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ICD-10 code
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ICD-10 code description
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3
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Description of health condition studied
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Quality of life
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Fall self-efficacy score in Activities-specific Balance Confidence Scale
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Timepoint
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Measuring fall self-efficacy before the start of the intervention and random allocation and after the twelfth week and completion of the intervention
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Method of measurement
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Activities-specific Balance Confidence Scale questionnaire
2
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Description
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Self-care score in the Self-Care Questionnaire for the Elderly
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Timepoint
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Measuring self-care before the start of the intervention and random allocation and after the twelfth week and completion of the intervention
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Method of measurement
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Self-Care Questionnaire for the Elderly
3
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Description
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Quality of life score in WHO-5 Well-being questionnaire
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Timepoint
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Measuring Quality of life before the start of the intervention and random allocation and after the twelfth week and completion of the intervention
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Method of measurement
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WHO-5 Well-being questionnaire
Intervention groups
1
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Description
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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.
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Category
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N/A
2
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Description
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Control group: The control group received routine care and counseling.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahroud University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Still undecided - no release schedule yet
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When the data will become available and for how long
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Still undecided - no release schedule yet
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To whom data/document is available
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Researchers and students of academic and scientific institutions
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Under which criteria data/document could be used
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Still undecided - no release schedule yet
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From where data/document is obtainable
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ermiamaghsoodloo@gmail.com
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What processes are involved for a request to access data/document
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A clear explanation of why data access is needed
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Comments
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