Evaluating the Effect of family-centered empowerment on self-care of MS Jahrom patients in 2024-2025
Design
The clinical trial was designed as a randomized, triple-blind, parallel-group study with a control group. Participants were MS patients selected randomly using Random Number Generator software. The selected participants were then allocated to either the intervention or control group through random assignment facilitated by Random Allocation Software. Each group consisted of 31 participants, resulting in a total sample size of 62 individuals.
Settings and conduct
With ethics approval and IRCT code, MS patients from Jahrom MS Association were randomly chosen using Random Number Generator software and assigned to intervention or control groups via Random Allocation Software. All signed informed consent. A research assistant administered self-care questionnaires pre- and post-intervention. The control group received family-centered empowerment education post-study. The triple-blind trial kept group assignments hidden from the statistical consultant and data collector.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Confirmed diagnosis of multiple sclerosis by a neurologist.
Age between 18 and 50 years.
Not in an acute disease phase, with at least 6 weeks since the last relapse.
Sufficient ability for self-care.
At least 2 years since initial diagnosis.
No history of psychiatric disorders or drug addiction.
Exclusion Criteria:
Acute worsening of condition requiring hospitalization.
Death or migration.
Intervention groups
Intervention Group: MS patients from the Jahrom MS Association underwent a family-centered empowerment program with four steps:
Perceived threat
Enhancing self-efficacy
Increasing self-esteem via educational participation
Evaluation
Control Group: Received standard interventions from the MS Association
Main outcome variables
self-care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250313065061N1
Registration date:2025-05-03, 1404/02/13
Registration timing:prospective
Last update:2025-05-03, 1404/02/13
Update count:0
Registration date
2025-05-03, 1404/02/13
Registrant information
Name
MOHAMMAD GHAEDNIAY
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5426 1971
Email address
aminghaednia1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-05, 1404/02/15
Expected recruitment end date
2025-06-21, 1404/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating family-centered empowerment on self-care of MS Jahrom patients in 2024-2025
Public title
nvestigating family-centered empowerment on self-care of MS patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining informed consent for study participation.
Definitive diagnosis of MS by a neurologist.
Being aged between 18 and 50 years.
Not being in the acute phase of the disease and at least 6 weeks having passed since the last disease relapse.
Possessing sufficient ability for self-care.
At least 2 years having passed since the initial diagnosis of the disease.
Having no history of psychiatric disorders or drug addiction.
Family members not being among healthcare providers.
Having no underlying diseases in the family.
Exclusion criteria:
Acute worsening of the patient's condition and hospitalization.
Death or migration of the patient and their family.
Failure of the caregiver to attend more than two empowerment sessions.
Lack of consent to continue the study for any reason.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
First, a list of MS patients will be obtained from the MS Society of Jahrom. Using the Random Number Generator software, random sampling will be performed, and random allocation into intervention and control groups will be carried out using the Random Allocation Software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was double-blinded, meaning that the statistical consultant and the data collector (research assistant) were unaware of the group assignments (intervention or control) at all stages.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jahrom University of Medical Sciences
Street address
Motahari Boulevard, Jahrom University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
74157-13945
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.JUMS.REC.1403.116
Health conditions studied
1
Description of health condition studied
thalassemia
ICD-10 code
D56
ICD-10 code description
Thalassemia
Primary outcomes
1
Description
self-care
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Demographic characteristics questionnaire (patient and family caregiver) and self-care questionnaire of Momeni et al.
Secondary outcomes
1
Description
Timepoint
Method of measurement
2
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: MS patients from the Jahrom MS Association underwent a family-centered empowerment program with four steps:Perceived threatEnhancing self-efficacyIncreasing self-esteem via educational participation Evaluation
Category
Lifestyle
2
Description
Control group:Received standard interventions from the MS Association
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Society
Full name of responsible person
Dr Rasool Eslami Akbar
Street address
Motahari Boulevard, Jahrom University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0409
Email
eslamiakbarrasool@ gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr Rasool Eslami Akbar
Street address
Motahari Boulevard, Jahrom University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0409
Email
eslamiakbarrasool@ gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
dr rasool Eslami Akbar
Position
Member of the university faculty, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Motahari Boulevard, Jahrom University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0409
Email
eslamiakbarrasool@ gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
dr rasool Eslami Akbar
Position
Member of the university faculty, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Motahari Boulevard, Jahrom University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0409
Email
eslamiakbarrasool@ gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
MOHAMMAD GHAEDNIAY
Position
Senior student
Latest degree
Bachelor
Other areas of specialty/work
Internal Medicine
Street address
ALLEY3,FAJR STREET,SHARAK ENGHELAB,JAHROM,FARS
City
JAHROM
Province
Fars
Postal code
7414846199
Phone
+98 71 5426 1971
Fax
Email
Aminghaednia1995@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
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