Determining the effect of self-care virtual education on the severity of symptoms and the level of daily activities of patients with Covid 19
Design
The present study is a parallel randomized two-group clinical trial study that will be performed with the participation of 100 patients with Covid 19.
Settings and conduct
The present study is a parallel randomized two-group clinical trial study that will be performed with the participation of 100 patients with Covid 19 in Shahid Beheshti Hospital in Hamadan. Training materials will be provided to members through the training channel four days after discharge. The intervention will include training self-care behaviors in patients in the field of strategies to reduce pain and pulmonary and functional rehabilitation in these patients. Information is sent to patients at the beginning of each week through the software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Conscious consent to participate in the study, Access to mobile phones and the ability to use the program for virtual education, Be literate.
Exclusion criteria: The patient's unwillingness to continue cooperating, Death of the patient
Intervention groups
Intervention group: Training will be held in three sessions per week on a daily basis for three weeks, and training materials will be provided to members through the channel. In each session, the content will be placed in a short and understandable form in the form of text with Word software, image, audio, or video clip in the channel. In order to train the self-care group of the intervention group, it is tried to communicate with patients through mobile phone programs and using virtual networks in accordance with the laws of the Islamic Republic of Iran.
Control group: In patients in the control group, only routine training will be given to patients at discharge.
Main outcome variables
Level of daily activities
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N38
Registration date:2022-01-25, 1400/11/05
Registration timing:registered_while_recruiting
Last update:2022-01-25, 1400/11/05
Update count:0
Registration date
2022-01-25, 1400/11/05
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care virtual education on the severity of symptoms and the level of daily activities of patients with Covid 19
Public title
effect of self-care virtual education on the severity of symptoms and the level of daily activities
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious consent to participate in the study
Mobile access and the ability to use for virtual learning
Be literate
Having Covid disease 19 with the approval of a specialist
Exclusion criteria:
Re-hospitalization of the patient during the self-care training course
Death of the patient
Absence of the patient in more than two training sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be performed using the permutation blocks method. First, the four blocks of ABBA, AABB, and ABAB, BBAA, BAAB, BABA will be produced in a number that covers the study sample and will be placed in envelopes. Then, when patients enter the study, one of the envelopes is selected at random and the first four patients will be assigned to two groups according to the desired block. This process will continue until the total number of samples is completed.
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2021-11-27, 1400/09/06
Ethics committee reference number
IR.UMSHA.REC.1400.693
Health conditions studied
1
Description of health condition studied
Covid -19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Level of daily activities
Timepoint
Before and immediately after the end of self-care education
Method of measurement
Activities of Daily Living scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-care training will be held every other day for three weeks. Training in the first week will be about aerobic and strength training, the second week will be about stretching and balance exercises, and the third week will be about breathing exercises. The topic of each session is stated at the beginning of the session.
Category
Rehabilitation
2
Description
Control group: In patients in the control group, only routine training will be given to patients at discharge.