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 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 (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 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 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 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 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 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 18 Name of recruitment center Health House Recruitment center Full name of responsible person Name of recruitment center Aging Expert Daneshjo Health House Street address Full name of responsible person Nobonyad Sq, Sharak Shahid Chamran Aging Expert City Street address Enghelab Collage, Moaalem Sq Tehran City Tehran 24 Recruitment center 19 Name of recruitment center Recruitment center Satarkhan Health House Name of recruitment center Full name of responsible person Sardaran-E Shahid Health House Aging Expert Full name of responsible person Street address Aging Expert No 14, 6 Alley, Niro St, Satarkhan Street address City Sardaran Shahid Sport Bldg, Shokri St, End of Tehran Dolatkhah City 25 Tehran Recruitment center Name of recruitment center 20 Beheshteh Madaran Health House Recruitment center Full name of responsible person Name of recruitment center Aging Expert Hamzeh Abad Health House Street address Full name of responsible person Jolfa St, Behashteh Madaran Sq Aging Expert City Street address Tehran North East of Hamzeh Abad City 26 Tehran Recruitment center Name of recruitment center 21 Shemran no Health House Recruitment center Full name of responsible person Name of recruitment center Aging Expert Hamkar Health House Street address Full name of responsible person Hengam Ave, Sq, Alghadir Park Aging Expert City Street address Tehran Municipal Area 20, City 27 Tehran Recruitment center Name of recruitment center 22 Hesarak Health House Recruitment center Full name of responsible person

5 Aging Expert mahaleh Beryanak Street address City Tohid Ave, Simon Bolivar St, Shorayari Office Tehran City Tehran 33 Recruitment center 28 Name of recruitment center Recruitment center Monoriyeh Health House Name of recruitment center Full name of responsible person Jehan Ara Health House Aging Expert Full name of responsible person Street address Aging Expert No 95, Floor 4, Moayeri St, Monoriyeh Sq Street address City No 3, 59 Alley, End of Jehan Ara St Tehran City Tehran 34 Recruitment center 29 Name of recruitment center Recruitment center Golshan Health House Name of recruitment center Full name of responsible person Kaj Health house Aging Expert Full name of responsible person Street address Aging Expert Shahid Mosavi Kyani Alley, 15 khordad St Street address City Kaj St, Shariati Ave, In Front of Khanvadeh Hospital Tehran City Tehran 35 Recruitment center 30 Name of recruitment center Recruitment center Dehghan Health House Name of recruitment center Full name of responsible person Shaghayegh Health House Aging Expert Full name of responsible person Street address Aging Expert End of 21 Mertri Dehghan, pirozi Ave Street address City Baghery High way, Near Emam Bagher Mousq Tehran City Tehran 36 Recruitment center 31 Name of recruitment center Recruitment center Khavaran Health House Name of recruitment center Full name of responsible person Shamshiri Health House Aging Expert Full name of responsible person Street address Aging Expert Ajab Gol St, 17 Shahrivar Ave, Shohada Sq Street address City Maleki St, shamshiri Ave, Near Shamshiri Park Tehran City Tehran 37 Recruitment center 32 Name of recruitment center Recruitment center North Afsariyeh Health House Name of recruitment center Full name of responsible person Beryanak Health House Aging Expert Full name of responsible person Street address Aging Expert 35 St, Between Afsariyeh High Way and First 15 Metri Street address City Davati St, First of Khosh, Shahid Arab St, Saraye Tehran

6 38 Name of recruitment center Vila Shar Health House Recruitment center Full name of responsible person Name of recruitment center Aging Expert Besat Health House Street address Full name of responsible person Deghban Park, Vila Shahr Shahrak Aging Expert City Street address Tehran zanganeh St, After Zanganeh Day Market City Tehran 44 Recruitment center 39 Name of recruitment center Recruitment center Rihan Health House Name of recruitment center Full name of responsible person Jalili Health House Aging Expert Full name of responsible person Street address Aging Expert Alzahra Sport Salon, Hemat High Way, Shahid Bagheri Street address shahrak Agha Yari St, Jalili Sq City City Tehran Tehran Sponsors / Funding sources 40 Recruitment center 1 Name of recruitment center Sponsor Hamkar Health House Name of organization / entity Full name of responsible person Tehran University of Medical Science, Vice chancellor Aging Expert for research Street address Full name of responsible person Municipal Area 18 Dr. Masoud Yunesian City Street address Tehran Central Buildig of Tehran University of Medical Science, Intersection Ghods, Keshavarz Blvd 41 City Tehran Recruitment center Grant name Name of recruitment center Grant code / Reference number Resalat Health House Is the source of funding the same sponsor Full name of responsible person organization/entity? Aging Expert Yes Street address Title of funding source Shahid Davood St, Behashte Zahra High Way, saleh Abad Sharak Tehran University of Medical Science, Vice chancellor for City research Tehran Proportion provided by this source Public or private sector empty 42 Domestic or foreign origin Recruitment center empty Name of recruitment center Category of foreign source of funding Shahid Ghayori Health House empty Full name of responsible person Country of origin Aging Expert Type of organization providing the funding Street address empty salehi Alley, Ghayori St, Varamin Serah City 2 Tehran Sponsor Name of organization / entity 43 Community Based Participatory Research Center, Recruitment center Iranian Institute for Reduction of High-Risk Behavior

7 Full name of responsible person Mohaham Hossaine Taghdisi Dr. Rajabi Position Street address PhD Health Promotion, Proffesor/Advisore/Supervisor 7 Floor, Gol Bldg, North Kargar St, Intersection Other areas of specialty/work Keshavarz Blvd Street address City Public Health School Collage, Alvand Ave, Arghantin Tehran Sq, Tehran, Iran Grant name City Grant code / Reference number Iran Is the source of funding the same sponsor Postal code organization/entity? Phone Yes +98 21 8877 9118 Title of funding source Fax Community Based Participatory Research Center, Iranian Email Institute for Reduction of High-Risk Behavior [email protected] Proportion provided by this source Web page address Public or private sector empty Person responsible for updating data Domestic or foreign origin empty Contact Category of foreign source of funding Name of organization / entity empty Tehran University of Medical Science, School of Public Country of origin Health Type of organization providing the funding Full name of responsible person empty Fatemeh Estebsari Position Person responsible for general inquiries PhD candidate in Health Education and Health Promotion Contact Other areas of specialty/work Name of organization / entity Street address Tehran University of Medical Science Department of Health Education&Promotion , College Full name of responsible person of Public Health, Tehran University of Medical Fatemeh Estebsari Science(TUMS), Ghods Ave, Poor Sina St, Enghelab Position square, Tehran, Iran City PhD Candidate Tehran Other areas of specialty/work Postal code Street address Phone Department of Health Education&Promotion , College +98 21 6637 2890 of Public Health, Tehran University of Medical Fax Science(TUMS), Poor Sina St, Ghods Ave, Enghelab Email square,Tehran, Iran [email protected] City Web page address Tehran Postal code Phone Sharing plan +98 21 6637 0710 Fax Deidentified Individual Participant Data Set (IPD) Email empty fa-estebsari@ yahoo.com; [email protected] Study Protocol empty Web page address Statistical Analysis Plan empty Person responsible for scientific Informed Consent Form inquiries empty Clinical Study Report Contact empty Name of organization / entity Analytic Code Iran University of Medical Scince,Department of empty Health Education& promotio, School of Public Health Data Dictionary Full name of responsible person empty

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