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Study of the effect of education based on self-efficacy theory on self-efficacy , health literacy and the quality of life of health volunteers in Mashhad health centers

Protocol summary

Study aim
The aim of this study was to assess the effect of a health literacy training intervention on the self-efficacy and quality of life of menopausal women.
Design
A randomized controlled trial method was used to enroll 165 menopausal women from healthcare clinics in the Mashhad, Iran. All participants received a code, then, they were randomly divided into two control and intervention groups.The Short Test of Functional Health Literacy` Assessment (S-TOFHLA), and Menopause-Specific Quality Of Life (MENQOL) questionnaires, were answered by each subject before, immediately after and 3 months post-training. Multiple statistical analysis were used to assess whether the educational intervention improved woment's health literacy, self-efficacy and quality of life after intervention.
Settings and conduct
The study population was women who referred to health centers in Mashhad, Iran. All participants were randomly divided into two control and training intervention groups. They filled all questionnaires before and 3 months after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: intention, age between 40-60 years , ability to read and write and living in Mashhad Exclusion criteria: Death, Unwillingness to participate in training sessions, Unable to give informed consent and they had suffered Refractory disease ‌
Intervention groups
All participants were allocated into an educational intervention group and control group. In intervention group, the educational intervention was conducted based on the potential gaps with focus on Health Literacy in Practice (HLP) strategies. The control group did not receive any intervention education.
Main outcome variables
health literacy, self-efficacy, quality of life of menopausal women

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160710028863N26
Registration date: 2018-05-04, 1397/02/14
Registration timing: retrospective

Last update: 2018-05-04, 1397/02/14
Update count: 0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Nooshin Peyman
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 502 6195
Email address
peymann@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical sciences
Expected recruitment start date
2016-08-28, 1395/06/07
Expected recruitment end date
2016-12-08, 1395/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of education based on self-efficacy theory on self-efficacy , health literacy and the quality of life of health volunteers in Mashhad health centers
Public title
Quality of Life، self efficacy and Health Literacy in menopause
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Person’s intention to participate in the study Iranian health volunteer Age between 40-60 years Ability to read and write Residing in Mashhad Iranian nationality
Exclusion criteria:
Death Unwillingness to participate in training sessions Refractory disease Unable to give informed consent They had suffered an acute-myocardial infarction and kidney disease had visual impairment, mental disturbance illiteracy, and upper limb disability
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 165
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling was used to select eligible women from the 2 health care center in Mashhad, Iran. Health secretaries provided different lists of women and all the women are assigned number. The researcher then used tables of random number to select each number of the women. in final, 60 menopausal women enrolled for the initial study were randomly assigned to intervention (n= 30) and control groups (n=30).
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 Mashhad University of Medical Sciences
Street address
School of Health, Daneshgah18 Street, Danshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2016-09-03, 1395/06/13
Ethics committee reference number
IR.MUMS.REC.1395.320

Health conditions studied

1

Description of health condition studied
menopause
ICD-10 code
N95.1
ICD-10 code description
N95 Symptomatic menopausal or female climacteric states

Primary outcomes

1

Description
improvement of self efficacy
Timepoint
Before The intervention, immediately and three months after interve
Method of measurement
general self-efficacy questionnaire (Sherer)

Secondary outcomes

1

Description
health literacy
Timepoint
Before The intervention, immediately and three months after intervention
Method of measurement
The Short Test of Functional Health Literacy` Assessment (S-TOFHLA)

2

Description
improvement of quality of life
Timepoint
Before The intervention, immediately and three months after intervention
Method of measurement
Menopause-Specific Quality Of Life (MENQOL) questionnaires

Intervention groups

1

Description
Intervention group: education training was conducted during 6 sessions (60 minutes) to address skills to health promotion based on Health Literacy in Practice (HLP) strategies and self efficacy theory among menopause women.
Category
Behavior

2

Description
Control group: this groups did not received any education training
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center of Mashhad University of Medical Sciences
Full name of responsible person
Nooshin Peyman
Street address
Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3180 1337
Email
peymann@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghod
Street address
Mashhad University of Medical Sciences International Office, Administration Center (Qoreishi Building), Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3180 1337
Email
tafaghodim@mums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nooshin Peyman
Position
Department of Health Education and Health Promotion, between 16th and 18th Daneshgah, Daneshgah Stre
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 4633
Fax
Email
peymann@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nooshin Peyman
Position
PhD in Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Daneshgah18 Street, Danshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 4633
Fax
Email
peymann@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
نوشین پیمان
Position
Professor Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion, Daneshgah Street, between Daneshgah 16 -18
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 4633
Fax
Email
Peymann@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Potential data is sharable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
Dr Nooshin Peyman Peymann@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email
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