The effect of education and telephone follow up on Family Caregivers burden of Patients with multiple scelorsis referred to the Hamadans MS association in 2019
The purpose of this study is to empower caregivers to access health goals. And determination of the effect of education and follow up on the caring burden of the family of MS patients in Hamedan in 1398.
Design
Clinical trial with control and intermediate group, with parallel group, blind, randomized
Settings and conduct
Hamadans MS association،The participants were blind.
Participants/Inclusion and exclusion criteria
The criteria for entry for caregivers include: having satisfaction for participation in the study, at least elementary education, age from 18 to 55 years, direct responsibility for patient care and lack of mental illness diagnosed and treated, with a score of 21-88 in the patient's care.
Intervention groups
Before intervention, demographic and zarit questionnaires will be completed by the family carers of MS patients, and the EDSS scale will be determined in both groups.After completing the control group sampling, in the intervention group, caregivers of MS patients are trained at the center of the Hamadan MS Society during three sessions of one hour during the two weeks. Tutorials will be delivered as lectures, consultations, questions and answers, and group discussions. In the control group, they will receive the routine training of the MS Society and two months after the start of the study, again, the questionnaires Will be completed from both groups.
Main outcome variables
Caregivers burden
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20170130032303N6
Registration date:2019-12-28, 1398/10/07
Registration timing:registered_while_recruiting
Last update:2019-12-28, 1398/10/07
Update count:0
Registration date
2019-12-28, 1398/10/07
Registrant information
Name
Morteza Shamsizadeh
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0535
Email address
shamsizadeh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-22, 1398/04/31
Expected recruitment end date
2020-03-14, 1398/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education and telephone follow up on Family Caregivers burden of Patients with multiple scelorsis referred to the Hamadans MS association in 2019
Public title
The effect of education and telephone follow up on Family Caregivers burden of Patients with multiple scelorsis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having satisfaction for participating in the study in caregivers
Caregivers have at least elementary education
Caregiver take direct care of the patient
Has a caregiver burden rating of 21 to 88
Age between 18 and 55 years old
Satisfaction of patients to participate in the study
Exclusion criteria:
Hospitalization
Death of the patient
Lack of family cooperation
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
More than 1 sample in each individual
Number of samples in each individual:
47
Minimum required sample size with 5% error and 90% power, 47 persons per group (intervention or control).
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
does not have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
G35,G37. Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
care giver burden score21to88
Timepoint
Measure the care burden before and after training
Method of measurement
Zarit's Cargiven burden Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" They will be trained by a nurse who is aware of the patients medical condition. Patients will then be followed up by telephone two months after discharge.
Category
Lifestyle
2
Description
Control group: In the control group, routine care has been taken and there is no intervention. Before and after the study, patients with caregiver burden questionnaire will be examined.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Issues of Hazrat Ghaem - Association for the Protection of Patients MS Mehr.
Full name of responsible person
Mehrdokht Mazdeh
Street address
Special Issues of Hazrat Ghaem - Association for the Protection of Patients MS Mehr., Boujay Al Zaman Blvd., Hamedan Town
City
Hamadan
Province
Hamadan
Postal code
6513674438
Phone
+98 81 1267 6185
Email
hamedan_ms_society@yahoo.com
Web page address
http://hamedan.isna.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmida Street., Paguhesh Squre
City
Hamedan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0717
Email
m_research@umsha.ac.ir
Web page address
http://www.umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?