Clinical Trial Protocol Iranian Registry of Clinical Trials

Clinical Trial Protocol Iranian Registry of Clinical Trials

Clinical Trial Protocol Iranian Registry of Clinical Trials 02 Oct 2021 Effect of educational intervention on health promotion and social protection in the prevention of elder abuse ( an explanatory model) in the elderly covers 22 districts of Tehran in 92 years Protocol summary Registration date 2014-01-29, 1392/11/09 Summary Objectives: Assessing the effect of factors related to Registrant information health promoting behaviors such as social support, self- Name efficacy on risk of elder abuse. This clinical trial study Fatemeh Estebsari was conducted on 464 elderly people over 60 years who Name of organization / entity were admitted at Health Houses for 12 months. Design: Tehran University of Medical Science Clinical Trial Study, no blinded, not used placebo, parallel Country assignment, purpose prevention, phase 2 and 3. Sitting Iran (Islamic Republic of) and conduct: Participants were selected through a two- Phone stage cluster sampling and were placed in the control +98 21 6637 2890 and intervention groups (232 participants in each group). Email address SCARED tool was used to determine degree of risk and [email protected] vulnerability to abuse in elders. The health promoting Recruitment status behaviors (Healthy lifestyle), social support and self- Recruitment complete efficacy questionnaires will be completed by the study Funding source participants. Inclusion criteria: Age over 60 years; 1- Tehran University of Medical Science,Vice chancellor speaking in Farsi and willingness to participate in the for research 2-Community Based Participatory Research study. Exclusion criteria: Elders who are not able to Center, Iranian Institute for Reduction of High-risk speak Farsi and Existence of psychological problems. Behaviors, Tehran University of Medical Science, Tehran, Intervention: An educational and empowerment program Iran based on health promoting behaviors such as nutrition, physical activity, social support and social relations, stress management conducted to prevention and dealing Expected recruitment start date with the elder abuse for three months. Main outcome 2013-06-21, 1392/03/31 measures /variables: Health promoting behaviors, social Expected recruitment end date support, self-efficacy and degree of elder abuse risk. 2013-10-22, 1392/07/30 Actual recruitment start date General information empty Actual recruitment end date Acronym empty IRCT registration information Trial completion date IRCT registration number: IRCT2013070813904N1 empty Registration date: 2014-01-29, 1392/11/09 Registration timing: retrospective Scientific title Effect of educational intervention on health promotion and social protection in the prevention of elder abuse ( Last update: an explanatory model) in the elderly covers 22 districts Update count: 0 of Tehran in 92 years 1 Public title 1 Elders Health Promotion and Social Suppor Description of health condition studied Purpose . Prevention ICD-10 code Inclusion/Exclusion criteria . Inclusion Criteria: Age over 60 years; willingness to ICD-10 code description participate in the study; speaking in Farsi; non existence . of mental health disorders; orientation to place and time. Exclusion Criteria: Withdrawing from the study, existence of disability or special disease, elders who are not able to Primary outcomes speak in Farsi; having trouble visiting the center; existence of psychological and mental disorders; lack of 1 orientation to place and time; seniors who are reluctant Description to participate in the study. social support Age Timepoint From 60 years old to 80 years old 6 month Gender Method of measurement Both Personal Resource Questionnaire 85- Part 2(PRQ85) Phase 2-3 2 Groups that have been masked Description No information general self efficacy Sample size Timepoint Target sample size: 464 6 month Randomization (investigator's opinion) Method of measurement Randomized Questionnaire general self efficacy(GSE) Randomization description Blinding (investigator's opinion) 3 Not blinded Blinding description Description Placebo lifestyle Timepoint Not used 6 month Assignment Method of measurement Parallel quastionnaire lifestyle: Health-Promoting Lifestyle Profile Other design features II (HPLP II ) Secondary Ids 4 empty Description Risk of Elder Abuse Ethics committees Timepoint 6 month Method of measurement 1 SCARED tool Ethics committee Name of ethics committee Secondary outcomes Ethics Committee of Tehran University of Medical Science Street address 1 Keshavarz Blvd, Ghods Av, Tehran Description City social support Tehran Timepoint Postal code before intervention and 3 month after intervention Approval date Method of measurement 2013-11-21, 1392/08/30 Personal Resource Questionnaire 85- Part 2(PRQ 85 Ethics committee reference number part2) 19230.30/8/92 2 Health conditions studied Description 2 Self Efficacy Full name of responsible person Timepoint Aging Expert before intervention and 3 month after intervention Street address Method of measurement Daneshjo Blvd, Golrizan Park questionnairGeneral Self Efficacy(GSE) City Tehran 3 2 Description Life Style Recruitment center Timepoint Name of recruitment center before intervention and 3 month after intervention Saadat Abad Health House Method of measurement Full name of responsible person questionnair HPLP2 Aging Expert Street address 4 Pardis salamat, Hagh Talab Ave, Saadat Abad City Description Tehran Risk of Elder Abuse Timepoint 3 before intervention and 3 month after intervention Method of measurement Recruitment center SCARED tool Name of recruitment center Dehe Vanak Health House Intervention groups Full name of responsible person Aging Expert Street address 1 St Shahid Majidpoor, Sq Dehe Vanak Description City Intervention will apply only to the intervention group. Tehran The intervention group of 22 home health selected from22 municipalities in 22 regions. Educational content 4 includes knowledge of old age, familiarity threats and Recruitment center risk factors, age, physical activity in old age, healthy Name of recruitment center nutrition, social, physical, mental and spiritual - mental Pasdaran Health House and leisure that will run only for the intervention group. Full name of responsible person Educations in ten 45-minute sessions based on adult Aging Expert learning strategies based on educational technology and Street address methods such as lectures, questions and answers and No 106, 8th Negarstan, Pasdaran problem-solving also will use. In addition to its City educational content to CD, manuals and pamphlets will Tehran be distributed in. Category Lifestyle 5 Recruitment center 2 Name of recruitment center Ekbatan Health House Description Full name of responsible person None of the interventions applied for the intervention Aging Expert group during the study will be applied to the control Street address group. After completion of data collection, research and Between Phase 1&2, Basij Sq, Behind the Municipal education designed to control will be implemented. District 6, Ebatan Saraye Mohaleh, Ekbatan Category City N/A Tehran Recruitment centers 6 Recruitment center 1 Name of recruitment center Recruitment center Enghelab Health House Name of recruitment center Full name of responsible person Welenjak Health House Aging Expert 3 Street address No 106, Rah paima St, Helal Ahmar Ave Groun Floor, Municipal District 6 Bldg, Fallahpoor City Alley, Sepahbod Gharani Ave Tehran City Tehran 12 Recruitment center 7 Name of recruitment center Recruitment center Shahrdari Ferdosi Health House Name of recruitment center Full name of responsible person Bahar Health House Aging Expert Full name of responsible person Street address Aging Expert Bank Alley, Ferdosi Ave, Emam Khomaini Sq Street address City Bahar Ave, Khodaparast St, Joharchi, Oatad Lorzadeh Tehran Bostan, Saraye Mahaleh City 13 Tehran Recruitment center Name of recruitment center 8 Mosafer Health House Recruitment center Full name of responsible person Name of recruitment center Aging Expert Haft House Health House Street address Full name of responsible person Damavand Ave, East Terminal Aging Expert City Street address Tehran Narmak Sq, Post Office Near, Narmak City 14 Tehran Recruitment center Name of recruitment center 9 Dolab Health House Recruitment center Full name of responsible person Name of recruitment center Aging Expert Ostad Moeen Health House Street address Full name of responsible person Amir Solymanieh St, Khavaran Ave, Khorasan Sq Aging Expert City Street address Tehran Near Shahre Ketab, Almahdi Park, Azadi Sq City 15 Tehran Recruitment center Name of recruitment center 10 Khavaran Health House Recruitment center Full name of responsible person Name of recruitment center Aging Expert Haft Chenar Health House Street address Full name of responsible person Kavaran ّFarhangsara, Kavaran Ave Aging Expert City Street address Tehran Shahid Arabi St, HaftChenar Saraye Mahaleh City 16 Tehran Recruitment center Name of recruitment center 11 Khazaneh Health House Recruitment center Full name of responsible person Name of recruitment center Aging Expert Heala Ahmar Health House Street address Full name of responsible person Parastoie St, kazaneh Saraye Mahaleh Aging Expert City Street address Tehran 4 17 Name of recruitment center Ziba Dasht Health House Recruitment center Full name of responsible person Name of recruitment center Aging Expert Sajjad Health House Street address Full name of responsible person In Front of 17 St, Sahel Ave, Dehkadeh Blv, Afra Park Aging Expert City Street address Tehran Abozar St, Behbodi Ave City Tehran 23 Recruitment center

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