Protocol summary

Summary
Objectives: Assessing the effect of factors related to health promoting behaviors such as social support, self-efficacy on risk of elder abuse. This clinical trial study was conducted on 464 elderly people over 60 years who were admitted at Health Houses for 12 months. Design: Clinical Trial Study, no blinded, not used placebo, parallel assignment, purpose prevention, phase 2 and 3. Sitting and conduct: Participants were selected through a two-stage cluster sampling and were placed in the control and intervention groups (232 participants in each group). SCARED tool was used to determine degree of risk and vulnerability to abuse in elders. The health promoting behaviors (Healthy lifestyle), social support and self-efficacy questionnaires will be completed by the study participants. Inclusion criteria: Age over 60 years; speaking in Farsi and willingness to participate in the study. Exclusion criteria: Elders who are not able to speak Farsi and Existence of psychological problems. Intervention: An educational and empowerment program based on health promoting behaviors such as nutrition, physical activity, social support and social relations, stress management conducted to prevention and dealing with the elder abuse for three months. Main outcome measures /variables: Health promoting behaviors, social support, self-efficacy and degree of elder abuse risk.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013070813904N1
Registration date: 2014-01-29, 1392/11/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-29, 1392/11/09
Registrant information
Name
Fatemeh Estebsari
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6637 2890
Email address
f-estebsari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Tehran University of Medical Science,Vice chancellor for research 2-Community Based Participatory Research Center, Iranian Institute for Reduction of High-risk Behaviors, Tehran University of Medical Science, Tehran, Iran
Expected recruitment start date
2013-06-21, 1392/03/31
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Elders Health Promotion and Social Suppor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Age over 60 years; willingness to 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 speak in Farsi; having trouble visiting the center; existence of psychological and mental disorders; lack of orientation to place and time; seniors who are reluctant to participate in the study.
Age
From 60 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 464
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
Keshavarz Blvd, Ghods Av, Tehran
City
Tehran
Postal code
Approval date
2013-11-21, 1392/08/30
Ethics committee reference number
19230.30/8/92

Health conditions studied

1

Description of health condition studied
.
ICD-10 code
.
ICD-10 code description
.

Primary outcomes

1

Description
social support
Timepoint
6 month
Method of measurement
Personal Resource Questionnaire 85- Part 2(PRQ85)

2

Description
general self efficacy
Timepoint
6 month
Method of measurement
Questionnaire general self efficacy(GSE)

3

Description
lifestyle
Timepoint
6 month
Method of measurement
quastionnaire lifestyle: Health-Promoting Lifestyle Profile II (HPLP II )

4

Description
Risk of Elder Abuse
Timepoint
6 month
Method of measurement
SCARED tool

Secondary outcomes

1

Description
social support
Timepoint
before intervention and 3 month after intervention
Method of measurement
Personal Resource Questionnaire 85- Part 2(PRQ 85 part2)

2

Description
Self Efficacy
Timepoint
before intervention and 3 month after intervention
Method of measurement
questionnairGeneral Self Efficacy(GSE)

3

Description
Life Style
Timepoint
before intervention and 3 month after intervention
Method of measurement
questionnair HPLP2

4

Description
Risk of Elder Abuse
Timepoint
before intervention and 3 month after intervention
Method of measurement
SCARED tool

Intervention groups

1

Description
Intervention will apply only to the intervention group. The intervention group of 22 home health selected from22 municipalities in 22 regions. Educational content includes knowledge of old age, familiarity threats and risk factors, age, physical activity in old age, healthy nutrition, social, physical, mental and spiritual - mental and leisure that will run only for the intervention group. Educations in ten 45-minute sessions based on adult learning strategies based on educational technology and methods such as lectures, questions and answers and problem-solving also will use. In addition to its educational content to CD, manuals and pamphlets will be distributed in.
Category
Lifestyle

2

Description
None of the interventions applied for the intervention group during the study will be applied to the control group. After completion of data collection, research and education designed to control will be implemented.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Welenjak Health House
Full name of responsible person
Aging Expert
Street address
Daneshjo Blvd, Golrizan Park
City
Tehran

2

Recruitment center
Name of recruitment center
Saadat Abad Health House
Full name of responsible person
Aging Expert
Street address
Pardis salamat, Hagh Talab Ave, Saadat Abad
City
Tehran

3

Recruitment center
Name of recruitment center
Dehe Vanak Health House
Full name of responsible person
Aging Expert
Street address
St Shahid Majidpoor, Sq Dehe Vanak
City
Tehran

4

Recruitment center
Name of recruitment center
Pasdaran Health House
Full name of responsible person
Aging Expert
Street address
No 106, 8th Negarstan, Pasdaran
City
Tehran

5

Recruitment center
Name of recruitment center
Ekbatan Health House
Full name of responsible person
Aging Expert
Street address
Between Phase 1&2, Basij Sq, Behind the Municipal District 6, Ebatan Saraye Mohaleh, Ekbatan
City
Tehran

6

Recruitment center
Name of recruitment center
Enghelab Health House
Full name of responsible person
Aging Expert
Street address
Groun Floor, Municipal District 6 Bldg, Fallahpoor Alley, Sepahbod Gharani Ave
City
Tehran

7

Recruitment center
Name of recruitment center
Bahar Health House
Full name of responsible person
Aging Expert
Street address
Bahar Ave, Khodaparast St, Joharchi, Oatad Lorzadeh Bostan, Saraye Mahaleh
City
Tehran

8

Recruitment center
Name of recruitment center
Haft House Health House
Full name of responsible person
Aging Expert
Street address
Narmak Sq, Post Office Near, Narmak
City
Tehran

9

Recruitment center
Name of recruitment center
Ostad Moeen Health House
Full name of responsible person
Aging Expert
Street address
Near Shahre Ketab, Almahdi Park, Azadi Sq
City
Tehran

10

Recruitment center
Name of recruitment center
Haft Chenar Health House
Full name of responsible person
Aging Expert
Street address
Shahid Arabi St, HaftChenar Saraye Mahaleh
City
Tehran

11

Recruitment center
Name of recruitment center
Heala Ahmar Health House
Full name of responsible person
Aging Expert
Street address
No 106, Rah paima St, Helal Ahmar Ave
City
Tehran

12

Recruitment center
Name of recruitment center
Shahrdari Ferdosi Health House
Full name of responsible person
Aging Expert
Street address
Bank Alley, Ferdosi Ave, Emam Khomaini Sq
City
Tehran

13

Recruitment center
Name of recruitment center
Mosafer Health House
Full name of responsible person
Aging Expert
Street address
Damavand Ave, East Terminal
City
Tehran

14

Recruitment center
Name of recruitment center
Dolab Health House
Full name of responsible person
Aging Expert
Street address
Amir Solymanieh St, Khavaran Ave, Khorasan Sq
City
Tehran

15

Recruitment center
Name of recruitment center
Khavaran Health House
Full name of responsible person
Aging Expert
Street address
Kavaran ّFarhangsara, Kavaran Ave
City
Tehran

16

Recruitment center
Name of recruitment center
Khazaneh Health House
Full name of responsible person
Aging Expert
Street address
Parastoie St, kazaneh Saraye Mahaleh
City
Tehran

17

Recruitment center
Name of recruitment center
Sajjad Health House
Full name of responsible person
Aging Expert
Street address
Abozar St, Behbodi Ave
City
Tehran

18

Recruitment center
Name of recruitment center
Daneshjo Health House
Full name of responsible person
Aging Expert
Street address
Enghelab Collage, Moaalem Sq
City
Tehran

19

Recruitment center
Name of recruitment center
Sardaran-E Shahid Health House
Full name of responsible person
Aging Expert
Street address
Sardaran Shahid Sport Bldg, Shokri St, End of Dolatkhah
City
Tehran

20

Recruitment center
Name of recruitment center
Hamzeh Abad Health House
Full name of responsible person
Aging Expert
Street address
North East of Hamzeh Abad
City
Tehran

21

Recruitment center
Name of recruitment center
Hamkar Health House
Full name of responsible person
Aging Expert
Street address
Municipal Area 20, Tehransar
City
Tehran

22

Recruitment center
Name of recruitment center
Ziba Dasht Health House
Full name of responsible person
Aging Expert
Street address
In Front of 17 St, Sahel Ave, Dehkadeh Blv, Afra Park
City
Tehran

23

Recruitment center
Name of recruitment center
Farmanieh Health House
Full name of responsible person
Aging Expert
Street address
Nobonyad Sq, Sharak Shahid Chamran
City
Tehran

24

Recruitment center
Name of recruitment center
Satarkhan Health House
Full name of responsible person
Aging Expert
Street address
No 14, 6 Alley, Niro St, Satarkhan
City
Tehran

25

Recruitment center
Name of recruitment center
Beheshteh Madaran Health House
Full name of responsible person
Aging Expert
Street address
Jolfa St, Behashteh Madaran Sq
City
Tehran

26

Recruitment center
Name of recruitment center
Shemran no Health House
Full name of responsible person
Aging Expert
Street address
Hengam Ave, Resalat Sq, Alghadir Park
City
Tehran

27

Recruitment center
Name of recruitment center
Hesarak Health House
Full name of responsible person
Aging Expert
Street address
Tohid Ave, Simon Bolivar St, Shorayari Office
City
Tehran

28

Recruitment center
Name of recruitment center
Jehan Ara Health House
Full name of responsible person
Aging Expert
Street address
No 3, 59 Alley, End of Jehan Ara St
City
Tehran

29

Recruitment center
Name of recruitment center
Kaj Health house
Full name of responsible person
Aging Expert
Street address
Kaj St, Shariati Ave, In Front of Khanvadeh Hospital
City
Tehran

30

Recruitment center
Name of recruitment center
Shaghayegh Health House
Full name of responsible person
Aging Expert
Street address
Baghery High way, Near Emam Bagher Mousq
City
Tehran

31

Recruitment center
Name of recruitment center
Shamshiri Health House
Full name of responsible person
Aging Expert
Street address
Maleki St, shamshiri Ave, Near Shamshiri Park
City
Tehran

32

Recruitment center
Name of recruitment center
Beryanak Health House
Full name of responsible person
Aging Expert
Street address
Davati St, First of Khosh, Shahid Arab St, Saraye mahaleh Beryanak
City
Tehran

33

Recruitment center
Name of recruitment center
Monoriyeh Health House
Full name of responsible person
Aging Expert
Street address
No 95, Floor 4, Moayeri St, Monoriyeh Sq
City
Tehran

34

Recruitment center
Name of recruitment center
Golshan Health House
Full name of responsible person
Aging Expert
Street address
Shahid Mosavi Kyani Alley, 15 khordad St
City
Tehran

35

Recruitment center
Name of recruitment center
Dehghan Health House
Full name of responsible person
Aging Expert
Street address
End of 21 Mertri Dehghan, pirozi Ave
City
Tehran

36

Recruitment center
Name of recruitment center
Khavaran Health House
Full name of responsible person
Aging Expert
Street address
Ajab Gol St, 17 Shahrivar Ave, Shohada Sq
City
Tehran

37

Recruitment center
Name of recruitment center
North Afsariyeh Health House
Full name of responsible person
Aging Expert
Street address
35 St, Between Afsariyeh High Way and First 15 Metri
City
Tehran

38

Recruitment center
Name of recruitment center
Besat Health House
Full name of responsible person
Aging Expert
Street address
zanganeh St, After Zanganeh Day Market
City
Tehran

39

Recruitment center
Name of recruitment center
Jalili Health House
Full name of responsible person
Aging Expert
Street address
Agha Yari St, Jalili Sq
City
Tehran

40

Recruitment center
Name of recruitment center
Hamkar Health House
Full name of responsible person
Aging Expert
Street address
Municipal Area 18
City
Tehran

41

Recruitment center
Name of recruitment center
Resalat Health House
Full name of responsible person
Aging Expert
Street address
Shahid Davood St, Behashte Zahra High Way, saleh Abad Sharak
City
Tehran

42

Recruitment center
Name of recruitment center
Shahid Ghayori Health House
Full name of responsible person
Aging Expert
Street address
salehi Alley, Ghayori St, Varamin Serah
City
Tehran

43

Recruitment center
Name of recruitment center
Vila Shar Health House
Full name of responsible person
Aging Expert
Street address
Deghban Park, Vila Shahr Shahrak
City
Tehran

44

Recruitment center
Name of recruitment center
Rihan Health House
Full name of responsible person
Aging Expert
Street address
Alzahra Sport Salon, Hemat High Way, Shahid Bagheri shahrak
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science, Vice chancellor for research
Full name of responsible person
Dr. Masoud Yunesian
Street address
Central Buildig of Tehran University of Medical Science, Intersection Ghods, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science, Vice chancellor for research
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Community Based Participatory Research Center, Iranian Institute for Reduction of High-Risk Behavior
Full name of responsible person
Dr. Rajabi
Street address
7 Floor, Gol Bldg, North Kargar St, Intersection Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Community Based Participatory Research Center, Iranian Institute for Reduction of High-Risk Behavior
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Fatemeh Estebsari
Position
PhD Candidate
Other areas of specialty/work
Street address
Department of Health Education&Promotion , College of Public Health, Tehran University of Medical Science(TUMS), Poor Sina St, Ghods Ave, Enghelab square,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6637 0710
Fax
Email
fa-estebsari@ yahoo.com; f-estebsari@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Scince,Department of Health Education& promotio, School of Public Health
Full name of responsible person
Mohaham Hossaine Taghdisi
Position
PhD Health Promotion, Proffesor/Advisore/Supervisor
Other areas of specialty/work
Street address
Public Health School Collage, Alvand Ave, Arghantin Sq, Tehran, Iran
City
Iran
Postal code
Phone
+98 21 8877 9118
Fax
Email
taghdisi.mh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Science, School of Public Health
Full name of responsible person
Fatemeh Estebsari
Position
PhD candidate in Health Education and Health Promotion
Other areas of specialty/work
Street address
Department of Health Education&Promotion , College of Public Health, Tehran University of Medical Science(TUMS), Ghods Ave, Poor Sina St, Enghelab square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6637 2890
Fax
Email
fa_estebsari@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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