Protocol summary

Summary
Iranian society is facing with the phenomenon of aging and attention to mental health in well-being of this vulnerable group is important. Thus aim of this study was to determine the effect of education based on social cognitive theory on mental health among elderly people living in nursing homes. This study is a experimental research that will conduct the first on 203 (by Census) and the intervention-stage on 90 (by randomly selected) elderly people living in nursing homes. Educational intervention will do based on Social Cognitive Theory. Data will be collect by demographic information questionnaire and general health questionnaire and a questionnaire consistent with the structures of Social Cognitive theory, that complete by both groups in before and after intervention (12 weeks later).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101328529N3
Registration date: 2016-10-30, 1395/08/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Hadi Tehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3853 8530
Email address
tehranih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-11-20, 1394/08/29
Expected recruitment end date
2016-08-15, 1395/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education based on social cognitive theory on mental health among elderly people living in nursing homes.
Public title
Effect of education based on social cognitive theory on mental health among elderly people living in nursing homes.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- who agreed to participate; 2- Minimum age =60 years; 3- Do not have a cognitive disorder; 4- Minimum stay in nursing homes=3 months Exclusion criteria: They do not want to cooperate; absence of more than 1 in training sessions;For any reason during the study lost his mind and not be able to continue their cooperation; death
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Mashhad University of Medical Sciences
Street address
Administration Center(Qoreishi Building), Daneshgah St, Mashhad , Iran
City
Mashhad
Postal code
Approval date
2016-07-31, 1395/05/10
Ethics committee reference number
IR.MUMS.REC.1395.192

Health conditions studied

1

Description of health condition studied
Mental Health Disorder
ICD-10 code
F00-F09
ICD-10 code description
Organic, including symptomatic, mental disorders

Primary outcomes

1

Description
Mental health
Timepoint
Before intervention and 3 months after the intervention
Method of measurement
General health questionnaire

Secondary outcomes

1

Description
Construct of social cognitive theory
Timepoint
Before intervention and 3 months after the intervention
Method of measurement
questionnaire

Intervention groups

1

Description
The intervention group received educational content based on effective structures of social cognitive theory. Educational content based on predetermined objectives presented in 4 sessions(90 minutes)
Category
Behavior

2

Description
control group: No intervention was done for control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nursing Homes
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Mashhad ,Daneshgah St,Qoreishi Building-
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Other areas of specialty/work
Street address
School of Public Health
City
Mashhad
Postal code
Phone
+98 35 1853 8530
Fax
Email
tehranih@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences, Mashhad, Iran
Full name of responsible person
Dr.Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Other areas of specialty/work
Street address
School of Public Health
City
Mashhad
Postal code
Phone
+98 51 3853 8530
Fax
Email
tehranih@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Other areas of specialty/work
Street address
School of Public Health
City
Mashhad
Postal code
Phone
+98 35 1853 8530
Fax
Email
tehranih@mums.ac.ir
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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