The determining the effect of family-centered empowerment model on the health literacy of care givers and behavior of patients with multiple sclerosis in Bojnord
Design
70 caregivers of MS patients were randomly assigned to parallel intervention and control groups and participants are given a code. The intervention is conducted in 5 sessions of 90 minutes for the intervention group.
Settings and conduct
Place of intervention is the North Khorasan MS Society. The intervention group is trained based on a family-centered empowerment model and the control group does not receive any training and they are evaluated with a questionnaire after three months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: living with the patient; and day-care responsibilities of the patient
Exclusion criteria: having a history of diseases (such as mental disorders; cognitive impairment; history of drug addiction and other neurological disorders), refusal to continue participating in the study.
Intervention groups
70 patients and carers were randomly divided into two groups (n = 35). The intervention group is empowered and the control group does not receive any training.
Main outcome variables
Health Literacy, Behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160917029843N4
Registration date:2018-03-09, 1396/12/18
Registration timing:retrospective
Last update:2018-03-09, 1396/12/18
Update count:0
Registration date
2018-03-09, 1396/12/18
Registrant information
Name
Mohammad Vahedian-Shahroodi
Name of organization / entity
Social Determinants of Health Research Center, Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3189 2202
Email address
vahedianm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model on the health literacy of care givers and behavior of patients with multiple sclerosis
Public title
Empowering people with MS family-based approach - central
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Living with the patient
Have desire and cooperation to participate in the research
Responsibility for daily care of the patient
Exclusion criteria:
Unwillingness to continue cooperation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random number table
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
University 18 Ave., School of Public Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.MUMS.REC.1396.107
Health conditions studied
1
Description of health condition studied
MS patient behavior
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Health Literacy of care givers
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Health Literacy Questionnaire TOFHLA
2
Description
MS patient behavior
Timepoint
self made questionnaire on the behavior of a patient with MS
Method of measurement
Before intervention, immediately after intervention, 2 months after intervention
Secondary outcomes
1
Description
Self Efficacy
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
2
Description
Self Esteem
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
3
Description
Knowledge about MS
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
The intervention group, which includes 35 caregivers of MS patients, receives educational intervention. Training intervention consists of 5 sessions of 90 minutes and training is based on the dimensions of the family-centered empowerment model (knowledge, self-esteem and self-esteem).
Category
Behavior
2
Description
Control group: included 35 caregivers of MS patients and there is no intervention on the control group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
North Khorasan MS Society
Full name of responsible person
یاسمن جعفری
Street address
Plaque 131,Before the City Park, East Taleghani Avenue
City
Bojnourd
Province
North Khorasan
Postal code
9415645745
Phone
+98 58 3241 8507
Email
vahedianm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah St18– Mashhad – Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 3007
Email
vahedianm@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
Dr Mohammad Vahedian Shahroodi
Position
Assistant Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University 18 Ave., School of Public Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3854 4833
Fax
+98 51 3852 2775
Email
vahedianm@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
Dr Mohammad Vahedian Shahroodi
Position
Assistant Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University 18 Ave., School of Public Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3854 4833
Fax
Email
vahedianm@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 Mohammad Vahedian Shahroodi
Position
Assistant Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University 18 Ave., School of Public Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+385 44633
Fax
Email
vahedianm@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Potential data can be shared only after identification.
When the data will become available and for how long
Get started one month after the results are published.
To whom data/document is available
Researchers working in academia and academic
Under which criteria data/document could be used
The data are sent by official request through academic or organizational emails of the researchers after confirmation and identification of the sender.
From where data/document is obtainable
Dr. Mohammad Vahedian-Shahroodi vahedianm@mums.ac.ir
What processes are involved for a request to access data/document
The data are sent by official request through academic or organizational emails of the researchers after confirmation and identification of the sender.