Determining the Effect of Self-care Training Based on a Conceptual map on the Quality of life of Patients with Rheumatoid arthritis
Design
A non-randomized clinical trial with an intervention and control group, not blinded, the number of samples in each of the intervention and control groups is 35 people.
Settings and conduct
Rheumatoid arthritis patients who refer to Imam Hospital in Tehran during the study will be included in the study if they are eligible. First, the sample units of the control group and then the intervention group will be selected as convenience and continuously. Self-care training is conducted in the hospital classroom in person and using CDs in two sessions. The training time is coordinated with the patient and is maximum in two weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria are the age of the patient between 18 and 60 years, being literate, informed consent, definitive diagnosis of rheumatoid arthritis by a rheumatologist and the ability to use a CD. Exclusion criteria are having chronic diseases and other mental illnesses.
Intervention groups
First, the control group will be pre-tested and a month later, the post-test will be taken. Then self-care educational content is given to research units using CD. After reaching the desired sample size of the research in the control group, sampling is done for the intervention group. In this way, a pre-test will be done for the research units in the intervention group. Then the educational content is taught to the research units face-to-face and using CD in two sessions. At the end of the training, the educational content is also given to the research units in the form of a CD. Then, one month after the last training session, the post-test will be conducted.
Main outcome variables
Quality of life in rheumatoid arthritis patients; Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230405057828N1
Registration date:2023-06-23, 1402/04/02
Registration timing:registered_while_recruiting
Last update:2023-06-23, 1402/04/02
Update count:0
Registration date
2023-06-23, 1402/04/02
Registrant information
Name
Navid Dadashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3313 2054
Email address
ndadashi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-30, 1402/03/09
Expected recruitment end date
2023-09-10, 1402/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Self-care Training Based on Concept mapping on the Quality of Life of Rheumatoid Arthritis Patients
Public title
Investigation of self-care training on rheumatoid arthritis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age Between 18 and 60 Years
Being Literate in Reading and Writing
Informed Consent
Definitive Diagnosis of Rheumatoid Arthritis By a Rheumatologist
Ability to Use CD
Exclusion criteria:
Suffering From Other Chronic Diseases
Suffering From Mental Diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
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 in Research Faculty of Nursing and Midwifery and Faculty of Rehabilitation - Tehran
Street address
Room 604, Sixth floor, Central building of Tehran University of Medical Sciences, Intersection of Qods St, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1981656183
Approval date
2023-02-23, 1401/12/04
Ethics committee reference number
IR.TUMS.FNM.REC.1401.187
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
Quality of Life Score in the Quality of Life Questionnaire of Rheumatoid Arthritis Patients
Timepoint
Measuring the Quality of Life at the Beginning of the Study (Before the Start of the Intervention) and one Month After the Last Session of Self-care Training
Method of measurement
Questionnaire of Rheumatoid Arthritis Quality of Life
Secondary outcomes
1
Description
Pain Score of Rheumatoid Arthritis Patients
Timepoint
At the Beginning of the Study (Before the Start of the Intervention) and One Month After the Last Training Session
Method of measurement
Rheumatoid Arthritis Pain Scale Questionnaire
Intervention groups
1
Description
Control Group: First, a Pre-test will be Taken from the Control group, and a Post-test will be taken a month later, Then Self-care Educational content will be taught Face-to-face Using a CD. The training is done in two sessions, the time of training will be coordinated with the patient and it is maximum in two weeks. Educational content is about disease Recognition, complications, drugs and treatments, physical self-care, sports activities, pain management, performance self-care, health promotion methods, sleep and rest, diet and joint protection principles.
Category
Lifestyle
2
Description
Intervention group: A pre-test will be conducted for the research units in the intervention group, then self-care educational content will be taught face-to-face using CDs and laptops. The training is in the form of a concept map, which shows in the form of a visual diagram. The training is done in two sessions and in the classroom located in the hospital. The training time is coordinated with the patient and is maximum in two weeks. The time of each session is 45 minutes. The educational content is about disease recognition, complications, drugs and treatments, physical self-care, sports activities, pain management, performance self-care, health promotion methods, sleep and rest, diet and joint protection principles. Then, one month after the last training session, the post-test will be conducted. In this research, information will be collected using a three-part questionnaire including a demographic questionnaire, a quality of life questionnaire for rheumatoid arthritis patients, and a pain questionnaire for rheumatoid arthritis patients, which will take 10 minutes to fill out. The validity of the questionnaires will be checked by the relevant professors.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Navid Dadashi
Street address
Dr. Gharib Street, At the end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 936 741 6647
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Fotuhi
Street address
Research and Technology Vice-Chancellor, 6th floor, Central Organization of the University, corner of Quds St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Navid Dadashi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, No. 7, Mitsagh End, Kohistan Blvd, Kitab Square, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1981656183
Phone
+98 936 741 6647
Email
Naviddadashi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Navid Dadashi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, No. 7, Mitsagh End, Kohistan Blvd, Kitab Square, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1981656183
Phone
+98 936 741 6647
Email
Naviddadashi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Navid Dadashi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, No. 7, Mitsagh End, Kohistan Blvd, Kitab Square, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1981656183
Phone
+98 936 741 6647
Email
Naviddadashi@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
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