The Effect of Occupation-Based Interventions on Adaptive Response in Caregivers of People with Multiple Sclerosis Based on the Model of Occupational Adaptation
Investigating Impact of Occupation-based Interventions on the Adaptive Response in Caregivers of people with MS Based on the Model of Occupational Adaptation
Design
In a single blind randomized controlled clinical trial, 24 caregivers of MS patients will be randomly allocated into intervention (12 caregivers) and control (12 caregivers) groups.
Settings and conduct
The location of the evaluations and interventions is Shafa Yahyayan Hospital and assessor has been blinded before and after the interventions in two groups.
Participants/Inclusion and exclusion criteria
Caregivers: A caregiver can be one of family members of the patient that does not receive wages for caring. The ability to speak in Persian and reading and writing, should be between the ages of 18-60, engaging in caring for at least 6 months and 4 hours every day. Have the enough ability and time to participate in an intervention program independently. No serious psychological disturbances. People with MS: According to McDonald's diagnostic criteria, the patient has a definitive MS diagnosis. The MMSE cognitive test be higher than 22 . Have an EDSS score of 5-8 and finally ages of 18-60.
Intervention groups
Intervention will be conducted by a trained occupational therapist in 6 sessions of two hours over a period of 6 weeks. The intervention group will receive a treatment based of occupational adaptation model, and the control group will receive routine occupational therapy treatments in a format of pamphlet or a booklet
Main outcome variables
1- Level of occupational performance
2- Satisfaction of occupational performance
3- Occupational adaptation
4- Adaptive response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029260N3
Registration date:2019-04-02, 1398/01/13
Registration timing:registered_while_recruiting
Last update:2019-04-02, 1398/01/13
Update count:0
Registration date
2019-04-02, 1398/01/13
Registrant information
Name
Afsson Hassani Mehraban
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22227124
Email address
mehraban.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-16, 1397/12/25
Expected recruitment end date
2019-09-16, 1398/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Occupation-Based Interventions on Adaptive Response in Caregivers of People with Multiple Sclerosis Based on the Model of Occupational Adaptation
Public title
The Effect of Occupation-Based Interventions in Caregivers of People with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
caregivers: Caregivers: A caregiver can be one of family members of the patient, including the spouse, father, mother and children that does not receive wages for caring. If the patient has more than a caregiver, depending on the amount of hours of patient caring, the main caregiver is selected.
The ability to speak in Persian and reading and writing,
should be between the ages of 18-60,
engaging in caring for at least 6 months and 4 hours every day.
Have the enough ability and time to participate in an intervention program independently.
People with MS: According to McDonald's diagnostic criteria, the patient has a definitive MS diagnosis.
People with MS: The MMSE cognitive test be higher than 22 .
People with MS:Have an EDSS score of 5-8
People with MS: Ages of 18-60.
Exclusion criteria:
Having serious psychological disturbances
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Block: In this method, the number of participants are assigned to each group are the same and the size of all blocks is equal (for example, in a double-blind trial, 8 blocks are containing 4 participants in the intervention group and 4 participants in the control group)
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome evaluator: The person or people who evaluate the outcome or non-outcome of the outcome in the participants or collect data on the outcome variables.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
-
Approval date
2018-12-26, 1397/10/05
Ethics committee reference number
IR.IUMS.REC.1397.742
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
level of occupational performance
Timepoint
first, final, one month and three month after intervention
Method of measurement
Canadian Occupational Performance Measure(COPM)
2
Description
satisfaction of occupational performance
Timepoint
first, final, one month and three month after intervention
Method of measurement
Canadian Occupational Performance Measure(COPM)
3
Description
occupational adaptation
Timepoint
first, final, one month and three month after intervention
Method of measurement
Relative Mastery Measurement Scale(RMMS)
4
Description
adaptive response
Timepoint
first, final, one month and three month after intervention
Method of measurement
The coping with multiple sclerosis caregiving inventory(CMSCI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention will be conducted by a trained occupational therapist in 6 sessions of two hours over a period of 6 weeks. The intervention group will receive a treatment based of occupational adaptation model. This intervention program is based on two phase studies, a detailed review of resources and a qualitative phase of content analysis. In this intervention program, caregivers' occupational problems are treated.
Category
Rehabilitation
2
Description
Control group: the control group will receive routine occupational therapy treatments, Includes training and essential counseling, in a format of pamphlet or a booklet
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyayean Hospital
Full name of responsible person
Fatemeh Motaharinezhad
Street address
Mojahedin Eslam Street
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 3354 2001
Email
fatemeh_m20@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakoti
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8670 2503
Email
fatemeh_m20@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Motaharinezhad
Position
phD candidate
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation faculty, Maadar square
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 23 3332 8357
Email
fatemeh_m20@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsoon Hassani Mehraban
Position
phD
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation faculty, Maadar square
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2222 7124
Email
mehraban.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Motaharinezhad
Position
ph D candidate
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation faculty, Maadar square
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2222 7124
Email
fatemeh_m20@yahoo.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document