Determining the effect of the self-management training program on the self-efficacy of disease management and the quality of life of patients with scleroderma
Design
The clinical trial with a control group and without blinding and using a randomized block sampling method will be conducted on a total of 64 patients with scleroderma, and a table of random numbers will be used for randomization.
Settings and conduct
The implementation of the intervention will be a combination of lectures, group discussions and question and answer method. The place of the intervention will be done according to the presence of a suitable space (rooms with suitable dimensions and normal conditions in terms of temperature and light and free from environmental stimuli) in the rheumatologist's office.
Participants/Inclusion and exclusion criteria
inclusion criteria
1- Diagnosis of scleroderma disease based on the classification indices of the American University of Rheumatology and its evaluation and confirmation by a rheumatologist.
2- Age equal to or more than 18 years
exclusion criteria
1- Scleroderma patients hospitalized in wards
2- Simultaneously suffering from other musculoskeletal diseases such as lupus, rheumatoid arthritis, Behcet's syndrome, etc
Intervention groups
32 patients with scleroderma will be divided into 4 groups of eight people. The intervention is in 6 sessions of 60-75 minutes (self-management) and each session includes three parts reviewing the educational content presented in the previous session, including patients' questions and sharing their experiences, and giving assignments for the next meeting (5-10 minutes), which will be held once a week. The control group will receive routine care and treatments.
Main outcome variables
self-efficacy of disease management؛ Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230715058789N1
Registration date:2023-09-30, 1402/07/08
Registration timing:registered_while_recruiting
Last update:2023-09-30, 1402/07/08
Update count:0
Registration date
2023-09-30, 1402/07/08
Registrant information
Name
Mohammad Sadegh Hallaj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3571 4576
Email address
hallaj.ms@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-16, 1402/06/25
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management training program on self-efficacy of disease management and quality of life of patients with scleroderma
Public title
The effect of self-management training program on self-efficacy of disease management and quality of life of patients with scleroderma
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of scleroderma disease based on classification indices of the American University of Rheumatology and its evaluation and confirmation by a rheumatologist
Age equal to or greater than 18 years
Ability to communicate in Farsi
Non-diagnosis of mental disorders based on the statement of the patient and family
No use of psychoactive drugs in the last three months
Ability to answer questions
Failure to participate in any self-management or rehabilitation program within the past three months
More than one year has passed since the disease
Exclusion criteria:
Scleroderma patients hospitalized in wards
Simultaneously suffering from other musculoskeletal diseases such as lupus, rheumatoid arthritis, Behcet's syndrome, etc.
Age
From 18 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
The sampling method will be random and 16 blocks of 4. The randomization unit is individual and randomization will be done using a table of random 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 Jundi Shapur Ahvaz University of Medical Sciences
Street address
Ahvaz, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6183847897
Approval date
2023-08-19, 1402/05/28
Ethics committee reference number
IR.AJUMS.REC.1402.295
Health conditions studied
1
Description of health condition studied
Scleroderma
ICD-10 code
M00-M99
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
The self-efficacy of disease management score in the Self-Efficacy for Managing Chronic Disease questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention and three months after the end of the intervention
Method of measurement
Self-Efficacy for Managing Chronic Disease Questionnaire
2
Description
the quality of life score in the Systemic Sclerosis Quality of Life Questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention and three months after the end of the intervention
Method of measurement
Systemic Sclerosis Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is in 6 sessions of 60-75 minutes (self-management) and each session includes three parts reviewing the educational content presented in the previous session, including patients' questions and sharing their experiences, as well as presenting a new topic (40-45 minutes), drawing goals. Training and discussion will be about achieving the goal and progress towards the goals related to the sessions (20-25 minutes) and giving assignments for the next session (5-10 minutes), which will be held once a week.
Category
Rehabilitation
2
Description
Control group: This group will receive routine care and treatments, and before the intervention, after the intervention and three months after the intervention of the experimental group, the research questionnaires will be filled by the researcher's interview and questions and answers from the samples of the control group. According to the ethical standards of the research, the self-management program implemented in the intervention group will be given to the control group in the form of a booklet and after the questionnaires are filled by the control group in three months after the intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Mohammad Sadegh Hallaj
Street address
Ahvaz, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6183847897
Phone
+98 61 3374 3001
Email
hallaj.ms@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Hallaj
Street address
Ahvaz, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3314 0000
Email
hallaj.ms@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Hallaj
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3314 0000
Email
hallaj.ms@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Hallaj
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
۳۳۱۴۰۰۰۰ - 06133140000
Email
hallaj.ms@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Hallaj
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3314 0000
Email
hallaj.ms@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD