Determining the effect of self-care training based on motion graphics on the quality of life and life expectancy of patients with COVID-19 in Isfahan city in 2022
Design
The clinical trial has a control group with single blind and randomized parallel groups on 40 patients with COVID-19 and random numbers table is used for randomization.
Settings and conduct
The study was conducted in the office of Dr morteza Pourahmad(specializing in infectious diseases),during which 40 patients of COVID-19 who needed home quarantine were randomly divided into control and intervention groups,and then to the patients of the intervention group with motion graphics about nutrition.Patients during the recovery period,how to take drugs and drug and nutritional interactions,the principles of proper quarantine in a separate or shared room,use of common or separate sanitary facilities,principles of disposing of patient waste,duration of quarantine and issues related to after getting out of quarantine,tips related to the possibility of re-infection with the COVID-19 disease,time of corona vaccine injection,signs and symptoms of worsening of the disease,respiratory physiotherapy and psychological issues related to the quarantine period,were given and the patients of the control group were given PDF file.Data collection is done before and after the intervention.
Participants/Inclusion and exclusion criteria
Age between 20-65;Suffering from cancer diseases,history of using drugs that weaken the immune system
Intervention groups
The intervention group included patients with covid-19 who will benefit from self-care training at home using motion graphics, and the control group included patients with covid-19 who will benefit from self-care training at home in the form of a PDF file.
Main outcome variables
Improving the quality of life and life expectancy of patients with COVID-19 in home quarantine.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150715023216N13
Registration date:2022-11-20, 1401/08/29
Registration timing:prospective
Last update:2022-11-20, 1401/08/29
Update count:0
Registration date
2022-11-20, 1401/08/29
Registrant information
Name
Said Amini Rarani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3522 6158
Email address
ghadami@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motion-based self-care education on quality of life and life expectancy of patients with COVID-19
Public title
The effect of motion-based self-care education on quality of life and life expectancy of patients with COVID-19
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients have full consent to participate in the study.
Patients only need home quarantine.
The patients of the intervention group should have mobile phones with the ability to run motion graphics.
Control group patients should have mobile phones with the ability to run PDF.
Control group patients should have enough literacy to read and use PDF.
Intervention group patients should have good hearing.
Patients should be in the age range of 20-65 years.
No cancer diseases, no history of organ transplant surgeries and no use of drugs that weaken the immune system.
Exclusion criteria:
The people present in the study are not willing to continue cooperating with the research team at any stage of the research and for any reason.
Worsening of the disease and requiring hospitalization.
Failure to complete or incomplete completion of any of the quality of life and life expectancy questionnaires.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done using permutation block in such a way that intervention group patients will be given code A and control group patients will be given code B, and then the blocks will be determined by lottery and for example If the first block is AB, it means that the first patient who meets the study entry criteria will be in the intervention group and the second patient who meets the study entry criteria will be in the control group, and we will have twenty blocks in total.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this project, the data analyst will not be aware of which patients are in the intervention group and which are in the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.096
Health conditions studied
1
Description of health condition studied
COVID19
ICD-10 code
J98
ICD-10 code description
Other respiratory disorders
Primary outcomes
1
Description
The quality of life score from the standard quality of life questionnaire SF-36 in patients with COVID-19
Timepoint
The measurement of quality of life at the beginning of the study (before the intervention) and 14 days after receiving self-care training at home
Method of measurement
Standard questionnaire of quality of life SF-36
2
Description
Life expectancy score from Snyder's standard life expectancy questionnaire in patients with COVID-19
Timepoint
The measurement of Life expectancy at the beginning of the study (before the intervention) and 14 days after receiving self-care training at home
Method of measurement
Standard Snyder Life Expectancy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Receiving self-care education motion graphics (in the areas of feeding patients during the recovery period, how to take drugs and drug and nutritional interactions, principles of appropriate quarantine in a separate room or a shared room, using a shared toilet and bathroom with other family members or Separately, the principles of disposing of patient waste, the duration of quarantine and issues related to after leaving quarantine, points related to the possibility of re-infection with COVID-19, the time of corona vaccine injection, signs and symptoms of worsening of the disease, respiratory physiotherapy and psychological issues. Related to the quarantine period and topics related to fasting in the holy month of Ramadan in patients with COVID-19).
Category
Lifestyle
2
Description
Control group: Control group: receiving training in the areas of nutrition of patients during the recovery period, how to take drugs and drug and nutritional interactions, the principles of appropriate quarantine in a separate room or a shared room, using a shared toilet and bathroom with other family members or separately. , the principles of disposing of patient waste, the duration of quarantine and issues related to after leaving quarantine, points related to the possibility of re-infection with Covid-19, the time of corona vaccine injection, signs and symptoms of worsening of the disease, respiratory physiotherapy and related psychological issues To the quarantine period and topics related to fasting in the holy month of Ramadan in patients with covid-19 in PDF format
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Arman Medical Complex, Infectious Disease Specialist Office
Full name of responsible person
Morteza Pourahmad
Street address
Unit No.304, Second Floor, Arman Medical Complex, Alley No. 5, Tayeb Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3220 8571
Email
mortezapourahmad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Roya Kleishady
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7500
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadam
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7583
Email
ghadami@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Morteza Pourahmad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Unit No304, second floor, Arman Medical Complex, Alley number 5, Tayyab St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3220 8571
Email
mortezapourahmad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Khorammakan
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3028
Email
rezakhorammacan@gmail.com
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
disinclination
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