Protocol summary

Study aim
Determining the effect of teach back education on disease perception, fatigue severity and quality of life in patients with multiple sclerosis
Design
A two-group, randomized, controlled clinical trial with 60 patients.
Settings and conduct
This study is a randomized controlled clinical trial involving 60 patients with multiple sclerosis, which will be conducted in 1404 (2025-2026) at Besat Hospital in Hamadan. Thirty patients in the intervention group will receive four days of teach back education on the disease process, follow-up, and treatment, while the control group will only receive routine care and standard education.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Not having any mental disorders under treatment, ability to speak Persian, having a score between 2 and 6 on the expanded disability status scale, having multiple sclerosis for at least one year as diagnosed by a neurologist. Exclusion criteria:The occurrence of any severe physical or mental disorder during the study,patient's reluctance to continue cooperating to participate in the study
Intervention groups
Intervention Group: Patients will receive individual, teach back-based training over 4 sessions (every other day, each session lasting at least 30 minutes) on the disease process, treatment follow-up, fatigue reduction, and improvement of physical function. After each session, patients will restate the content in their own words. One month later, fatigue and illness perception questionnaires will be completed, and two months later, after a phone call and coordination, the quality of life questionnaire will be completed during an in-person visit to the MS association. Control Group: Only routine care will be provided, and no specific intervention will be conducted.
Main outcome variables
Quality of life, fatigue severity, perception of illness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160110025929N44
Registration date: 2025-03-27, 1404/01/07
Registration timing: prospective

Last update: 2025-03-27, 1404/01/07
Update count: 0
Registration date
2025-03-27, 1404/01/07
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-21, 1404/02/31
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of teach-back education on the understanding of disease, severity of fatigue, and quality of life in patients with multiple sclerosis referred to the MS
Public title
Impact of teach-back education on the understanding of disease, severity of fatigue, and quality of life
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Having multiple sclerosis for at least one year as diagnosed by a neurologist Having a score between 2 and 6 on the expanded disability status scale. Ability to speak Persian Not having any mental disorders under treatment
Exclusion criteria:
Patient's reluctance to continue cooperating to participate in the study The occurrence of any severe physical or mental disorder during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, four random blocks method is used. For this purpose, four sheets of paper are prepared. The letter A (intervention) is written on two sheets and the letter B (witness) is written on the other two sheets. The sheets are mixed together and removed by the researcher consecutively without placing them. This process is repeated for the number of qualified patients and whether each patient is group A or B is recorded.
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2024-10-26, 1403/08/05
Ethics committee reference number
IR.UMSHA.REC.1403.525

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
Timepoint
Two months after the intervention.
Method of measurement
Quality of life questionnaire for multiple sclerosis patients

2

Description
Fatigue severity
Timepoint
One month after the intervention.
Method of measurement
Fatigue severity questionnaire for multiple sclerosis patients

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in the intervention group will be educated in 4 sessions of thirty minutes, every other day, regarding the process of developing multiple sclerosis, the importance of the disease, adherence to treatment, and methods of reducing fatigue and improving quality of life using teach back education. Education will be provided face-to-face and through an educational booklet. At the end of each session, patients will be asked to express the information in their own language and as they have understood it. Patients' problems and ambiguities will be resolved at the end of each session.
Category
N/A

2

Description
Control group: In the control group, no special measures will be taken except for routine hospital measures and training.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital in Hamadan
Full name of responsible person
Masoud Khodaveisi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khodaveisi@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Reza Soltanian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
arsoltanian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Mobina Rangchian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3835 0535
Email
mobina.rangchian2020@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Masoud Khodaveisi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khodaveisi@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@umsha.ac.ir

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
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