Protocol summary

Summary
The purpose of this study is to survey empowerment program based on Health Belief Model on self-efficacy in the prevention of osteoporosis in the elderly population in Kashan.Method: The current study was a clinical trial design. Key criteria for the study of the elderly over 60 years old referred to Kashan health centers in 2017. 60 older will selected and placed in experimental (30 samples) and control groups (30 samples) .In the intervention group, empowerment program will do for one month and 8 sessions . In the control group, empowerment program will not be implemented.Both two groups will complete Osteoporosis Self-efficacy Scale before, immediately and one month after intervention. The two groups are compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201707248348N36
Registration date: 2017-10-12, 1396/07/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-12, 1396/07/20
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kashan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of empowerment program based on Health Belief Model on self-efficacy in the prevention of osteoporosis in the elderly population in Kashan
Public title
Effects of empowerment program on self-efficacy in the prevention of osteoporosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Older up 60 years؛ Having reading and writing skills. Exclusion criteria: Unwillingness to participate in the study ؛ the absence of more than one session.
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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 Kashan University of Medical Sciences
Street address
Kashan, Ravand Street, Kashan University of Medical Sciences
City
Kashan
Postal code
8715981151
Approval date
2017-09-04, 1396/06/13
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.14

Health conditions studied

1

Description of health condition studied
Osteoporosis
ICD-10 code
M81
ICD-10 code description
Osteoporosis without pathological fracture

Primary outcomes

1

Description
selfefficacy
Timepoint
Before, immediately and one month after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Health Belief
Timepoint
Before, immediately and one month after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: doing empowerment program, 8 sessions in one months.
Category
Prevention

2

Description
Control group: Empowerment program will not be implemented
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Street address
Ravand,Parastar Street,Kashan university of medical sciences
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahdi Vatankhah
Street address
Ravand,Parastar Street , Kashan University of Medical sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
PHD
Other areas of specialty/work
Street address
Ravand,Parastar Street , Kashan University of Medical sciences
City
Kashan
Postal code
8715981151
Phone
+98 31554021
Fax
+98 315556633
Email
mirbagher_n@kaums.ac.irsalam_20012003@yahoo.co.uk
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
PHD
Other areas of specialty/work
Street address
Ravand,Parastar Street , Kashan University of Medical sciences
City
Kashan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 315556633
Email
mirbagher_n@kaums.ac.ir salam_20012003@yahoo.co.uk
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
PHD
Other areas of specialty/work
Street address
Ravand,Parastar Street , Kashan University of Medical sciences
City
Kashan
Postal code
8715981151
Phone
+98 31 5555 0021
Fax
+98 315556633
Email
mirbagher_n@kaums.ac.ir salam_20012003@yahoo.co.uk
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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