the effect of self-care training by distance education on Functional Status and the quality of life of patients with rheumatoid arthritis referred to Honari clinic in Jahrom city in 2022
The effect of distance self-care education on performance and quality of life of patients with rheumatoid arthritis referred to Jahrom Honari Clinic in 2022
Design
This clinical trial study has an intervention and control group, randomized and double-blind. The sample size is 78 people, 39 people in the intervention group and 39 people in the control group.
Settings and conduct
The place of intervention is WhatsApp. However, completing the questionnaires in the pre-test and post-test is in person at the art clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
Rheumatoid arthritis with the diagnosis of the treating physician;
Age 60-18 years;
At least 6 months of history of the disease;
Be literate;
Have a smartphone that has at least WhatsApp software installed and can use it (can only work with WhatsApp software. No need to master the other software);
Aware of time and place, able to understand the Persian language, and no psychological illnesses according to the file;
Exclusion criteria include:
Advanced and malignant diseases such as cancer, chronic kidney disease, and advanced heart disease;
Taking psychotropic drugs;
Being employed in the treatment system;
Intervention groups
In this study, patients in the intervention group receive virtual training for five sessions (five weeks) and patients in the control group received only routine training provided by their physician.
Main outcome variables
The score of performance; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210114050037N1
Registration date:2022-07-03, 1401/04/12
Registration timing:prospective
Last update:2022-07-03, 1401/04/12
Update count:0
Registration date
2022-07-03, 1401/04/12
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
2022-08-01, 1401/05/10
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of self-care training by distance education on Functional Status and the quality of life of patients with rheumatoid arthritis referred to Honari clinic in Jahrom city in 2022
Public title
the effect of self-care training by distance education on Functional Status and the quality of life of patients with rheumatoid arthritis referred to Honari clinic in Jahrom city in 2022
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Rheumatoid arthritis with the diagnosis of the treating physician
Age 18-60 years
At least 6 months history of the disease
Be literate
Having a smartphone that has at least WhatsApp software installed and can use it (can only work with WhatsApp software. No need to master the other software)
Aware of time and place, able to understand Persian language, no psychological illnesses according to the file
Exclusion criteria:
Taking psychotropic drugs
Being employed in the treatment system
Having advanced and malignant diseases such as cancer, chronic kidney disease and advanced heart disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is simple random. In this way, the researcher registers their names in a list by number among the people who meet the inclusion criteria and are satisfied to participate in the research. Then these people will be assigned to the intervention and control groups of 39 people each group in every other sample manner.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the person who is responsible for completing the questionnaires is not aware of the allocation of patients in the intervention and control groups, and the person who is going to analyze the data is not aware of which patient is in the intervention or control group. In SPSS, the intervention and control groups will be named as groups 1 and 2, so that the analyst is not aware of the intervention and control groups.)
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
Ostad Motahhari Boulevard, Jahrom University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
74148-46199
Approval date
2022-06-19, 1401/03/29
Ethics committee reference number
IR.JUMS.REC.1401.025
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
Functional Status
Timepoint
Determining the average performance status before the intervention using a performance status questionnaire and one month after the intervention
Method of measurement
status functional questionnaire
2
Description
Quality of Life
Timepoint
Determining the average quality of life before the intervention by quality of life questionnaire for patients with rheumatoid arthritis and one month after the intervention
Method of measurement
Quality of life questionnaire for patients with rheumatoid arthritis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After completing the demographic questionnaires, performance status, and quality of life by this group, virtual training in WhatsApp for this group begins. On a certain day of the week for five weeks, an educational video is uploaded to WhatsApp so that patients in the intervention group can watch the video. Then, patients' feedback on the clip played in the WhatsApp group is examined. One month after the completion of the virtual training, the mentioned questionnaires will be completed by the patients again.
Category
Other
2
Description
Control group:After completing the demographic questionnaires, performance status and quality of life in this group, no intervention is performed for these patients and they are only subject to the routine training of the treating physician. One month after the completion of virtual training in the intervention group, the mentioned questionnaires are completed again by the patients in the control group. In addition, after that, all the broadcast clips for the intervention group will be provided to the patients of the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahrom city Honari clinic
Full name of responsible person
Ali asghar Rahmanian kushkaki
Street address
Ostad Motahhari Boulevard,Corner of Alley 25
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
Dr. Kavous Solhjoo
Street address
Jahrom, at the end of Ostad Motahhari Street
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
Jahrom, Madar Boulevard, 17th Alley
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 badiyepeyma
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahrom, at the end of Ostad Motahhari Boulevard
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
zbadiyepeyma@jums.ac.ir
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
Jahrom, Madar Boulevard, 17th Alley
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
Undecided - It is not yet known if there will be a plan to make this available
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