Determining the effect of virtual training on the quality of life and caregiving burden of stroke patients after discharge from Shahid Beheshti Hospital, Kashan.
Design
Clinical trial with control group, randomized, on 60 patients with quadruple block method
Settings and conduct
For the intervention group, a group will be formed in ETA and all caregivers will be added to this group simultaneously.
For 3 weeks and on even days of the week, the content of the educational care program, which has been approved by the competent professors, will be shared within the group, and each participant will be encouraged to use the materials at the same time through telephone follow-up.
The method of sending different files in the group will be the same on all days and at specific times, and the topics of the files sent each day will be appropriate for the discussion of that day. Each person will be reminded of the need to use the program files and follow up on the programs throughout the day through telephone calls and, if people are online, through messages in ETA.
Participants/Inclusion and exclusion criteria
Failure to respond to calls or messages sent at least twice by caregivers will result in exclusion from the study.
Intervention groups
In this study, educational messages about caring for stroke patients will be sent to caregivers of the intervention group in the form of pictures and educational videos through the social network Ita.
The control group only received routine hospital care.
Main outcome variables
Total Caregiver Burden Score for Stroke Patients,
Total Quality of Life Score for Stroke Patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042096N2
Registration date:2024-12-07, 1403/09/17
Registration timing:registered_while_recruiting
Last update:2024-12-07, 1403/09/17
Update count:0
Registration date
2024-12-07, 1403/09/17
Registrant information
Name
Maryam Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5520 5997
Email address
maryamheydari779@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-30, 1403/09/10
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual training on the quality of life and caregiver burden of stroke patients after discharge
Public title
The effect of virtual training on the quality of life and caregiving burden of stroke patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of stroke by doctor
Being discharged from the hospital
Family or informal caregiver
Age over 18 years
Having at least the ability to read, write and speak Persian
No hearing or vision impairment
Not taking neurotic drugs
Willingness to participate in research
Having written informed consent to participate in the research
Having a smartphone
Having skills in using social networks
No history of participating in an educational or research program similar to this study
Exclusion criteria:
Caregiver's unwillingness to continue participating in the research
Patient death during research
Failure to respond to calls or messages sent at least 2 times
Other serious disability concurrent with stroke in patients
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The study subjects will be randomly assigned to two intervention and control groups using a four-way block method. The randomization method will be as follows: first, the intervention group will be coded with the letter A and the control group with the letter B, and then, using the website www. sealedenvelope.com/simple-randomiser/v1/lists, a randomization list will be prepared by selecting a sample size of 60 (two groups of 30) and using a balanced four-way block method. Then, through the obtained randomization list, the subjects entering the study will be assigned to one of the two groups A or B. For example, suppose that in the first four-way block, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B, and so on until the last sample (the 60th person).
Blinding (investigator's opinion)
Single blinded
Blinding description
At the beginning of the study, caregivers were given the necessary explanations regarding how to perform the task, but no explanation was given about which group they would be placed in. At the end of the study, educational materials were provided to 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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8713783976
Approval date
2024-10-19, 1403/07/28
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1403.146
Health conditions studied
1
Description of health condition studied
Caregivers of stroke patients
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Zarit care burden score and World Health Organization short form quality of life score
Timepoint
Before, after and immediately 6 weeks after the intervention
Method of measurement
Zarit questionnaire is used to check caregiver burden. To check the quality of life questionnaire, the shortened form of the World Health Organization (WHOQOL-Brief) questionnaire is used due to the small number of questions and as a result of convenience.
Secondary outcomes
1
Description
Quality of life score
Timepoint
Before, after and 6 weeks after the intervention
Method of measurement
World Health Organization Quality of Life Short Form Questionnaire
Intervention groups
1
Description
Intervention group: For the intervention group, a group will be formed in ETA and all caregivers will be added to this group at the same time, and for 3 weeks and on even days of the week, the content of the educational care program, which has been approved by the relevant professors, will be shared within the group and from Through telephone follow-up, each participant will be encouraged to use the materials at the same time.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Maryam Heydari
Street address
Kilometer 5 of Ravand Road, Shahid Beheshti Hospital, Kashan
City
Kashan
Province
Isfehan
Postal code
8713783976
Phone
+98 31 5500 9999
Email
maryamheydari779@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
maryam heydari
Street address
Shahid Beheshti Hospital, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5500 9999
Email
beheshtihospital@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Maryam Heydari
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Hospital, Kashan
City
Kashan
Province
Isfehan
Postal code
8713783976
Phone
+98 31 5500 9999
Email
maryamheydari779@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Maryam Heydari
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Hospital, Kashan
City
Kashan
Province
Isfehan
Postal code
8713783976
Phone
+98 31 5500 9999
Email
maryamheydari779@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Maryam Heydari
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Hospital, Kashan
City
Kashan
Province
Isfehan
Postal code
8716896641
Phone
+98 31 5520 5997
Email
maryamheydari779@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available