Investigating the effect of mobile phone based training on the care burden and resilience of family caregivers of patients with implantable cardioverter defibrillator
Investigating the effect of mobile phone based training on the care burden and resilience of family caregivers of patients with implantable cardioverter defibrillator referring to medical centers in Shiraz 2024-2025
Design
A randomized controlled clinical trial, randomized trial
Settings and conduct
The place where the study was carried out was in Martyr Dr. Faqihi Educational and Medical Hospital and Abu Ali Sina Organ Transplantation Hospital in Shiraz . In this study, participants, the person who collects the results of the study and the statistician will be blinded to the groups until the end of the study and the completion of data analysis and reporting.
Participants/Inclusion and exclusion criteria
Conditions for entering the study:
1) Family caregiver of a patient with an implantable heart defibrillator
2) Age above 18 years
3) Understanding the Persian language and speaking it
4) Internet access and available virtual platform
5) Willingness to participate in the study
6) Not facing an emotional crisis such as the death of relatives and divorce during the last 6 months
7) Failure to participate in any other intervention or educational program
8) Absence of significant cognitive disorders such as dementia based on self-report
9) 6 months have passed since ICD implantation
Exclusion criteria:
1) Facing an emotional crisis during the study
2) Reluctance to continue cooperation
3) Non-participation in the intervention program for more than 3 consecutive days in full
Intervention groups
People in the intervention group receive materials with aspects of spiritual, psychological and informational support. People in the control group do not receive educational intervention through social networks.
Main outcome variables
Care burden and Resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191021045178N7
Registration date:2024-12-11, 1403/09/21
Registration timing:prospective
Last update:2024-12-11, 1403/09/21
Update count:0
Registration date
2024-12-11, 1403/09/21
Registrant information
Name
nilofar pasyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3623 6293
Email address
pasyarn@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-20, 1403/09/30
Expected recruitment end date
2025-04-19, 1404/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of mobile phone based training on the care burden and resilience of family caregivers of patients with implantable cardioverter defibrillator
Public title
Investigating the effect of mobile phone based training on the care burden and resilience of family caregivers of patients with implantable cardioverter defibrillator
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Family caregiver of a patient with an implantable heart defibrillator
Age above 18 years
Understanding the Persian language and speaking it
Internet access and available virtual platform
Willingness to participate in the study
Not facing an emotional crisis such as the death of relatives and divorce during the last 6 months
Non-participation in another intervention or educational program
Not suffering from a previously known mental illness (such as psychosis, major depression, anxiety) and taking psychotropic drugs based on self-report
Absence of significant cognitive disorders such as dementia based on self-report
6 months have passed since ICD implantation.
Exclusion criteria:
Facing an emotional crisis during the study
Reluctance to continue cooperation
Non-participation in the intervention program for more than 3 consecutive days in full
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, first, according to the list of patients in the clinic, a list of patients who meet the inclusion criteria is determined. Then sampling will be done by systematic random method. Select the appropriate distance (k) and select the names at equal intervals along the list. The distance or k is obtained by dividing the number of members of the study population by the number of members in the sample. It should be noted that the starting point for this regular selection process is random and is done from a table of random numbers. Finally, 72 people are included in the study as a sample.
Then, using blocking software, 72 people will be randomly placed in blocks A and B. Using this method, the number of people assigned to each block will be equal to 36 people. Finally, by tossing coins, each block will be placed in two groups of control and intervention
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the study, participants are given full explanations on how to perform the intervention before the intervention, but participants are unaware of the allocation of study groups. Also, in collecting data and completing questionnaires, the help of a researcher who is not aware of the division of groups will be used. Also, the statistician who analyzes the data will not know about the assignment of groups
Placebo
Not used
Assignment
Parallel
Other design features
The study participants are grouped as follows:Both the experimental and control groups in the study receive routine care. The experimental group receives an intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Schools of Nursing and Midwifery, Management and Medical Information s
Street address
Zand St., central building of Shiraz University of Medical Sciences, 7th floor, Research Vice-Chancellor
City
shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-10-12, 1403/07/21
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1403.072
Health conditions studied
1
Description of health condition studied
Presence of electronic cardiac devices
ICD-10 code
Z95.0
ICD-10 code description
Presence of electronic cardiac devices
2
Description of health condition studied
Counselling, unspecified
ICD-10 code
Z55.9
ICD-10 code description
Problem related to education and literacy, unspecified
Primary outcomes
1
Description
care burden score of Zarit et al.'s Care Burden Measurement Questionnaire
Timepoint
Before the intervention, immediately after the intervention and 4 weeks later
Method of measurement
Zarit et al.'s Care Burden Measurement Questionnaire
2
Description
resilience score of Connor and Davidson Resilience Questionnaire
Timepoint
Before the intervention, immediately after the intervention and 4 weeks later
Method of measurement
Connor and Davidson Resilience Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the researcher randomly selects the participants of the intervention group according to the conditions of entering the study and after introducing herself and recounting the objectives of the research, she provides them with the necessary and sufficient information regarding the nature and method of conducting the research. The voluntary aspect of their participation in this research is noted and written informed consent will be obtained from the participants. Then the questionnaires will be distributed and collected in the test group before the educational intervention. Intervention with educational will be approved by several faculty members. And it will be available to the participants of the test group in the form of an electronic file through social messengers and virtual space. It will be available to the test group and the questionnaires will be distributed and collected in the test group immediately after the educational intervention. Again, one month after the educational intervention, the questionnaires will be distributed and collected in the test group. The collected data will be entered into spss software version 25 and analyzed by a statistician.
Category
Other
2
Description
Control group: After obtaining written informed consent, questionnaires will be distributed and collected in three time periods before, immediately and one month after the intervention, and the educational intervention will not be available to the control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Ali Sina Organ Transplant Research Training Center
Full name of responsible person
Mahboobeh Bahrami
Street address
Shiraz, New Sadra City, Bostan Blvd., Pasdaran Blvd., No. 958, Abu Ali Sina Charitable Educational Research Center
City
Shiraz
Province
Fars
Postal code
7199467985
Phone
+98 71 3344 0000
Fax
+98 71 3344 9998
Email
abualisinacharity@gmail.com
Web page address
https://abooalisina.org/
2
Recruitment center
Name of recruitment center
Shahid Dr. Faqihi Medical Training Center
Full name of responsible person
Mahboobeh Bahrami
Street address
Shiraz - Karim Khan Zand Blvd. - Next to Medical School
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۶۱۱۴
Phone
+98 71 3235 1099
Fax
+98 71 3233 1634
Email
FaghihiHsp@Sums.ac.ir
Web page address
https://faghihi.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Deputy of Research and Technology, 7th Floor, Central building of Shiraz University of Medical Science, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
29224
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nilofar Pasyar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing education
Street address
Shiraz, Namazi Square, the beginning of the entrance of Namazi Hospital, College of Nursing and Midwifery of Hazrat Fateme.
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
npasyar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nilofar Pasyar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing education
Street address
Shiraz, Namazi Square, the beginning of the entrance of Namazi Hospital, College of Nursing and Midwifery of Hazrat Fateme
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
Npasyar@sums.ac.ir
Web page address
https://nurs-midwif.sums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nilofar Pasyar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing education
Street address
Shiraz, Namazi Square, the beginning of the entrance of Namazi Hospital, College of Nursing and Midwifery of Hazrat Fateme
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
Npasyar@sums.ac.ir
Web page address
https://nurs-midwif.sums.ac.ir/
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