Investigating the effect of implementing self-care training through smartphones on physical symptoms and quality of life of patients with systemic lupus erythematosus
Determining the effect of implementing self-care training through smartphones on physical symptoms and quality of life of patients with systemic lupus erythematosus.
Design
A clinical trial with a control group, with parallel groups without blinding, randomized on 50 patients, which will be used for randomization by computer software.
Settings and conduct
In this research, researchers first go to Honry's Clinic, located in Jahrom City, and add patients who meet the inclusion criteria to the study with the help of a rheumatology subspecialist. After completing the samples and performing randomization, a group will be formed for the patients of the intervention group in Eitta, and the training sessions, which include four sessions, will be sent to them on a weekly basis.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Confirmation of lupus disease (based on the diagnosis of a rheumatologist)
Be infected for at least 6 months
Willingness to participate in research
Minimum literacy
Having smartphones and internal software such as Soroush or Eitta
Age 18 to 65 years
exclusion criteria:
Unwillingness to continue cooperation during the research
Having advanced diseases such as cancer or chronic Renal failure
Having mental disorders
Intervention groups
In the intervention group, patients who meet the conditions for entering the study will be formed into a group in the Eitta messenger, and all patients will be added to that group, Then self-care training will be given to the group on a weekly basis, but the control group will only undergo routine training provided by the attending physician.
Main outcome variables
Education via smartphone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210114050037N3
Registration date:2023-09-04, 1402/06/13
Registration timing:prospective
Last update:2023-09-04, 1402/06/13
Update count:0
Registration date
2023-09-04, 1402/06/13
Registrant information
Name
َAli asghar Rahmanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 3628
Email address
lynurse8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of implementing self-care training through smartphones on physical symptoms and quality of life of patients with systemic lupus erythematosus
Public title
Investigating the effect of implementing self-care training through smartphones on physical symptoms and quality of life of patients with systemic lupus erythematosus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of lupus disease (based on the diagnosis of a rheumatologist)
Be infected for at least 6 months
Willingness to participate in research
Minimum literacy
Having smartphones and internal software such as Soroush or Eitta
Age 18 to 65 years
Exclusion criteria:
Unwillingness to continue cooperation during the research
Having advanced diseases such as cancer or chronic Renal failure
Having mental disorders
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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of samples is done using the block method and through statistical software.
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 Jahrom University of Medical Sciences
Street address
At the end of Ostad Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2023-08-21, 1402/05/30
Ethics committee reference number
IR.JUMS.REC.1402.045
Health conditions studied
1
Description of health condition studied
systemic lupus erythematosus
ICD-10 code
G73.7
ICD-10 code description
Myopathy in diseases classified elsewhere
Primary outcomes
1
Description
physical symptoms
Timepoint
Measurement of physical symptoms before the beginning of the educational intervention and one month after the end of the intervention
Method of measurement
Lupus Physical Symptoms Questionnaire
2
Description
Quality of Life
Timepoint
before the beginning of the educational intervention and one month after the end of the intervention
Method of measurement
Lupus quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After all the patients have completed the questionnaire, virtual training in the Eitta software for the intervention group will begin. In this way, a group will be formed in the Eitta software and all patients of the intervention group will be added to it, Then the audio files and related videos are uploaded to the group on a weekly basis.
Category
Other
2
Description
Control group: During the implementation of the educational intervention for the intervention group, the control group will not receive any training except routine training by the attending physician.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Honari Specialty and sub specialty clinic
Full name of responsible person
Ali asghar Rahmanian kushkaki
Street address
Ostad Motahari Boulevard, above Ostad Motahari Hospital, corner of the alley25
City
Jahrom
Province
Fars
Postal code
7415713945
Phone
+98 71 5434 2006
Email
honariclinic@jums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
kavoos solhjoo
Street address
At the end of Ostad Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5444 0821
Email
Solhjoo@JUMS.ac.ir
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
Ali asghar Rahmanian kushkaki
Position
Non Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mother Boulevard, 17th Street
City
Jahrom
Province
Fars
Postal code
7415854139
Phone
+98 71 5433 3628
Email
Lynurse8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
zohreh Badiyepeymaie Jahromi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ostad Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 917 392 4707
Email
z.badiyehpeyma@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Ali asghar Rahmanian kushkaki
Position
Non faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mother Boulevard, 17th Street
City
Jahrom
Province
Fars
Postal code
7415854139
Phone
+98 71 5433 3628
Email
lynurse8@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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