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IRCT20200928048868N1 IRCT 2020-12-07 Tehran University of Medical Sciences Oral health promotion based on behavioral model among elderly Oral health promotion interventions based on Health Action Process Approach model among elderly in Tehran in 2021 2021-01-04 anticipated 300 Complete https://irct.ir/trial/51273 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: To sample this study, a controlled clinical trial is performed by randomized multistage cluster sampling. According to the geographical map of Tehran, it is divided into three regions: north, center, and south. Tehran has 22 municipal districts, of which the north of Tehran includes 6 districts (1, 2, 3, 4, 5, and 22), the center of Tehran includes 10 districts (6, 7, 8, 9, 10, 11, 12, 13, 14 and 21) and the south of Tehran includes 6 districts (15, 16, 17, 18, 19 and 20). Using the index and rand functions of Excel software, two regions and a total of 6 municipal regions are selected randomly from each of these three regions of north, south, and center (stratified randomization). The city of Tehran includes 354 active neighborhood houses, each of the 22 districts of Tehran includes a number of these neighborhood houses. After randomly selecting 6 regions, the number of subdirectories of each of these regions is determined separately and entered into Excel software. From among the neighborhoods of each region, 4 houses are randomly selected with Excel software. Eventually, we will have 24 neighborhood halls (clusters). From the 4 houses selected in each area, 2 houses by simple randomization are assigned to intervention A and 2 houses to intervention B (control). According to the sample size of 300 people in this study, about 15 elderly people from each of the 24 selected clusters (24 neighborhood halls) will participate. To select people in each neighborhood home, we act in such a way that we prepare a list of elderly people who are members of the neighborhood home and using Excel software, 15 people are randomly selected from them and they are contacted and asked for Participation in the study is invited. If several people do not attend the study, we randomly select alternative people from the same list, Blinding description: 1. The examiner will be different in the baseline and follow up stages. Calibration of the examiners (inter-examiner) and each examiner will be done with himself (intra-examiner). 2. Examiners in the baseline and follow up stage are unaware of the study groups and how to allocate. 3. The people who do the training in group A (dentist) and group B (in charge of the neighborhood health center) will be different and are not study researchers. These people are trained to intervene. 4. When entering SPSS, the data will be entered with special codes so that the analyzer is not informed about the clusters and groups. 5. The researcher conducting the analysis is unaware of the intervention and allocation groups. N/A oral health promotion in elderly. Intervention 1: Intervention group: Practical training of oral health based on Health Action Process Approach model structures by a dentist along with presentation of educational pamphlet containing model structures. Intervention 2: Control group: Practical oral health training based on Health Action Process Approach model structures by the head of the neighborhood health center with the presentation of an educational pamphlet containing model structures. 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 I haven't decided yet - the publish schedule is still unknown
public Fatemeh Moghaddam Ghaeini
Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences (TUMS), North Karegar Ave.
Tehran Iran (Islamic Republic of) ۱۴۳۹۹۵۵۹۹۱ +98 21 8801 5950 fatemeh.moghaddam@hotmail.com Tehran University of Medical Sciences scientific Katayoun Sargeran
Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences (TUMS), North Karegar Ave.
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5960 k-sargeran@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 60 or more than 60 years old Ability to communicate with researchers sign the informed consent and voluntary participation in the research 60 years no limit Both Debilitating disease Uncontrolled systemic disease Non-Iranian citizens Prevention Prevention Intervention group: Practical training of oral health based on Health Action Process Approach model structures by a dentist along with presentation of educational pamphlet containing model structures Control group: Practical oral health training based on Health Action Process Approach model structures by the head of the neighborhood health center with the presentation of an educational pamphlet containing model structures Oral Health behaviors. Timepoint: At the beginning of study, one and three month after intervention. Method of measurement: Health Action Process Approach questionnaire and World Health Organization (WHO) standard form in elderly oral health habits. Oral Hygiene index. Timepoint: At the beginning of study: one and three month after intervention. Method of measurement: Oral and dental examination form. Tehran University of Medical Sciences Approved 2020-09-27 Ethnics committee School of Dentistry_Tehran university of medical sciences Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences (TUMS), North Karegar Ave. Tehran Tehran Iran (Islamic Republic of)