Investigating the effect of online training based on the professional nursing care educational program on the quality of life and caregiver burden of stroke patients
Determining the effect of online training based on professional nursing care training program on the quality of life and care burden of stroke patients
Design
Experimental type with the design of before and after intervention
Settings and conduct
Selected hospitals of Shahid Beheshti University of Sciences include Ayatollah Taleghani, Tajrish Martyrs, Imam Hossein, Luqman Hakim hospitals in Tehran City
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Being 18 years old or older
2. Having a confirmed stroke diagnosis by a neurologist (patients)
3. Being the primary caregiver of a family member diagnosed with a stroke (caregivers)
3. Having a smart mobile phone
Exclusion criteria:
1. Deterioration of the patient's physical and mental condition during the study so that it is not possible to continue participating in the study (patients)
2. Disconnection and lack of access to the person during the study
3. Unwillingness to continue participating during the study
Intervention groups
Control group: Routine education
Intervention group: A WhatsApp group will be formed for the patients and their caregivers in the intervention group, and educational materials based on the professional nursing care training program will be provided in written, audio and visual form every week. The care information taught to the patients and their caregivers in the intervention group will include the principles of stroke prevention, management of stroke complications, educational tips about drugs, therapeutic interventions and aids used, and the principles of follow-up of the care and treatment process. During the study, patients and their caregivers will be contacted by phone once a week and their questions will be answered.
Main outcome variables
Quality of life, Caregivers' care burden
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240609062065N1
Registration date:2024-08-31, 1403/06/10
Registration timing:prospective
Last update:2024-08-31, 1403/06/10
Update count:0
Registration date
2024-08-31, 1403/06/10
Registrant information
Name
Amir mohamad Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 095 7427
Email address
nazari.amir7009@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of online training based on the professional nursing care educational program on the quality of life and caregiver burden of stroke patients
Public title
Effect of online training on the quality of life and caregiver burden of stroke patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old
Having a confirmed diagnosis of stroke by a neurologist (patients)
Being the primary caregiver of a family member diagnosed with a stroke (caregivers)
Having a smart mobile phone
Exclusion criteria:
Deterioration of the patient's physical and mental condition during the study so that it is not possible to continue participating in the study (patients)
Disconnection and lack of access to the person during the study
Unwillingness to continue cooperation during the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate the study subjects, an independent research assistant who will not be involved in data collection, will use the Research Randomizer software (http://www.randomizer.org) to prepare a list of random numbers according to the sample size (numbers 1 and 2 ) where 1 and 2 represent the intervention group and the control group, respectively. The numbers will be printed separately and each one will be sealed in an envelope, so that only the research assistant will know the information inside each envelope. Then the researcher will open the envelopes in order. Therefore, eligible participants will be randomly assigned to one of two intervention and control groups.
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
Faculties of pharmacy, Nursing and Midwifery-Shahid Beheshti University of Medical Sciences
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.178
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Quality of life
Timepoint
Immediately after the intervention
Method of measurement
Quality of life questionnaire for stroke patients
2
Description
Quality of life
Timepoint
Two months after the intervention
Method of measurement
Quality of life questionnaire for stroke patients
3
Description
Caregiver care burden
Timepoint
Immediately after the intervention
Method of measurement
Zarit Caregiver Burden questionnaire
4
Description
Caregiver care burden
Timepoint
Two months after the intervention
Method of measurement
Zarit Caregiver Burden questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients and caregivers in the control group will receive routine hospital training.
Category
Other
2
Description
Intervention group: In the intervention group, after installing and teaching how to use the WhatsApp messenger software, a WhatsApp group will be formed for patients and their caregivers, and educational materials will be provided to them in written, audio, and visual form every week. The care information taught to patients and their caregivers includes the definition of stroke and its epidemiology, risk factors and principles of stroke prevention (primary and secondary), symptoms and complications of stroke, ischemic and hemorrhagic stroke care measures, common and ongoing stroke drugs, supplies and equipment used in stroke rehabilitation, eye care, urinary catheter care, nutritional care, prevention of pressure ulcers, activity, physical therapy and range of motion exercises, controlling the stress and emotions in stroke patients and their caregivers, counseling and emotional support, education and follow-up after hospital discharge and supporting organizations, which will be taught to patients and their caregivers in 15 1-hour sessions. Also, during the study, the researcher will call the patients and their caregivers once a week and answer their questions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Amir Mohamad Nazari
Street address
Shahrdari St
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Amir Mohamad Nazari
Street address
Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
ehmc.sbmu.ac@gmail.com
3
Recruitment center
Name of recruitment center
Loghman-e Hakim Hospital
Full name of responsible person
Amir Mohamad Nazari
Street address
Kamali St
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Velenjak, Arabi Street
City
Tehran
Province
Tehran
Postal code
1434743397
Phone
+98 21 2243 9770
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohamad Nazari
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
8861793445
Phone
+98 916 095 7427
Email
nazari.amir7009@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohamad Nazari
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
8861793445
Phone
+98 916 095 7427
Email
nazari.amir7009@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohamad Nazari
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
8861793445
Phone
+98 916 095 7427
Email
nazari.amir7009@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
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
Title and more details about the data/document
Participants data file
When the data will become available and for how long
One year after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Data will be made available upon request for secondary studies.
From where data/document is obtainable
Responsible author of the article
What processes are involved for a request to access data/document