The purpose of this study will be investigate the effect of home care of patients with multiple sclerosis on the burden of care and quality of life of their family caregivers.
Design
A randomized clinical trial with parallel group included control and intervention groups. The sample size for each group was calculated as 32 persons.
Settings and conduct
64 caregivers of patients with multiple sclerosis in Isfahan Welfare Organization at 2019 will be randomly divided into two groups: intervention (home care) and control (care received by family care givers).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages 18 to 65 years, no drug addiction and psychoactive drug and the home care plan has not been implemented for the patient and his or her family. Exclusion criteria: Not willing to cooperate at any stage of research and The patient's or family caregiver's death during studying..
Intervention groups
Intervention group: In the intervention group, the researcher will provide home care to patients and their family caregivers by going to home of multiple sclerosis patients for 8 two-hour sessions. It also provides caregivers with an instruction booklet about home care of patients with multiple sclerosis. Control group: The control group will receive only care by family caregivers, after the intervention, they will receive an Instruction booklet and the researcher will provide them with 3 home care sessions
Main outcome variables
Primary outcome of this study included: quality of life; family care givers burden
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190712044181N1
Registration date:2019-08-07, 1398/05/16
Registration timing:prospective
Last update:2019-08-07, 1398/05/16
Update count:0
Registration date
2019-08-07, 1398/05/16
Registrant information
Name
shahla Abolhassani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7548
Email address
abolhasani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2019-12-01, 1398/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of home care of people with multiple sclerosis on burden and quality of life of family caregivers at 2019.
Public title
The effect of home care of people with multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 65 years
No drug addiction and psychoactive drug
The home care plan has not been implemented for the patient and his or her family
Not be health care personnel
Ability to read and write
Exclusion criteria:
Unwillingness to cooperate at each stage of the research
The patient's or family caregiver's death during studying
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
First, 64 subjects will be selected by systematic random sampling and then divided into two groups of intervention and control through Even and Odd Numbers.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jereb Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.067
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Quality of life score of health-related quality of life in multiple sclerosis
Timepoint
At baseline, immediately after the intervention and one month after the intervention
Method of measurement
Health-related quality of life in multiple sclerosis questionnaire
2
Description
Burden score of Zarit burden scale
Timepoint
At baseline, immediately after the intervention and one month after the intervention
Method of measurement
Zarit burden scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The control group will receive only care by family caregivers, after the intervention, they will receive an Instruction booklet and the researcher will provide them with 3 home care sessions
Category
Lifestyle
2
Description
Intervention group: In the intervention group, the researcher will provide home care to patients and their family caregivers by going to home of multiple sclerosis patients for 8 two-hour sessions. It also provides caregivers with an instruction booklet about home care of patients with multiple sclerosis