Determining the Effect of telenursing-based family empowerment program on self-efficacy and treatment adherence in children with cystic fibrosis
Design
A RCT with an intervention and control group & sample size of 50 people.
Settings and conduct
Sampling will be done based on the inclusion criteria after obtaining the relevant permits from Shahid Beheshti University of Medical Sciences and coordinating with the relevant officials in the hospital.participants will be randomly assigned to the intervention and control groups based on the case number (Even numbers in intervention group/odd numbers in control group). The objectives and method of the research will be explained to participants and the consent form will be completed by them.For the intervention group, content presentation and follow-up have been planned twice a week for a period of 12 weeks. In the control group, there will be no intervention.The research environment is the lung department and Cystic fibrosis clinic of Mofid Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Access of a child or teenager to a smartphone.The child should be literate.The caregiver must be at least 18 years old.The caregiver is not part of the medical staff.
Exit criteria: Reluctance and refusal to continue participating study.
Intervention groups
For the intervention group, providing content and remote follow-up have been planned twice a week on the Skype platform for a period of 12 weeks in the form of sending an audio-video file or a training text (5-10 minutes) through the content link (Send Big website) to the mobile number of the teenager or home caregiver of children with Cystic fibrosis.Patients in the control group will have routine treatment and follow-up (monthly visits to the cystic fibrosis clinic, taking prescribed medications).
Main outcome variables
Self-efficacy, Treatment adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230717058822N1
Registration date:2023-07-19, 1402/04/28
Registration timing:registered_while_recruiting
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Fatemeh Rameh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
fatemerame1999@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-20, 1402/02/30
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of telenursing-based family empowerment program on self-efficacy and treatment adherence in children with cystic fibrosis
Public title
the effect of telenursing-based family empowerment program on self-efficacy and treatment adherence in children with cystic fibrosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The child or teenager has access to a smartphone.
The child does not suffer from mental, cognitive or any other chronic diseases.
The child should be able to speak Persian and be literate in reading and writing.
The child should live with both parents.
The home caregiver must be at least 18 years old.
The home caregiver should have at least a bachelor's degree, be fluent in the Persian language, and can answer questionnaires.
The mother is not part of the medical staff
The child's caregiver does not participate in a training course or class related to the child's illness before.
Exclusion criteria:
Reluctance and refusal to continue participating in the study
Inability to communicate due to reasons such as internet disconnection during at least two sessions
Failure to follow up on educational materials and lack of feedback in virtual question-and-answer sessions at least twice
Adverse complications during research for the child
Age
From 9 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In the current study, sampling will be done based on the inclusion criteria, and then the random allocation of the samples will be done using the simple randomization method to intervention and control group.
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 Shahid Beheshti University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Niayesh Intersection, Valiasr St., Tehran
Before the intervention, immediately after and one month after the intervention
Method of measurement
Pediatric Rating of Chronic Illness Self-efficacy (PRCISE)
2
Description
Treatment Adherence
Timepoint
Before the intervention, immediately after and one month after the intervention
Method of measurement
Measurement of adherence to treatment in chronic patients questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: interventional content with educational-practical and care-support model is in the form of an audio-visual file or an educational text (5-10 minutes) within a period of three months and through the content link (Send Big website) to the email address or number. It will be sent to teenager or caregiver of children with Cystic fibrosis, and after observation, remote follow-up will be done twice a week on the Skype platform, and the researcher will answer All of the questions that relate to contents.The content includes items related to the definition of chronic respiratory diseases and cystic fibrosis in children, the impact of the disease on the development of the child and family, the importance of receiving and implementing a therapeutic regimen, the importance of physical activity, types of respiratory exercises, management of respiratory symptoms, and training to clean the airways. performing creative games, performing drugs and oxygen therapy, exacerbation management and prevention, nutritional support, sleep challenges, stress and anxiety management, frequently asked questions session and create motivation in the implementation of the treatment regimen.
Category
Other
2
Description
Control group: Control group:No intervention will take place and the patients will receive their routine treatment plan.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children Hospital
Full name of responsible person
Fatemeh Rameh
Street address
Shariati St., above Hosseinieh Irshad, before Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1551415468
Phone
+98 21 2222 7021
Email
fateme.rame@yahoo.com
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
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niyayesh Cross-Section, ValiAsr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Fatemeh Rameh
Position
MSc Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niyayesh Cross-Section, ValiAsr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
fateme.rame@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Azam Shirinabadi Farahani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niyayesh Cross-Section, ValiAsr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
farahani1381@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Rameh
Position
MSc Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niyayesh Cross-Section, ValiAsr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
fateme.rame@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
There is no further information.
When the data will become available and for how long
The access is possible 6 months after the results are published.
To whom data/document is available
Researchers, students, hospital staff
Under which criteria data/document could be used
For the purpose of study and research by referring to this study
From where data/document is obtainable
Contacting with: fateme.rame@yahoo.com
What processes are involved for a request to access data/document
After sending an e-mail to the above-mentioned address, the maximum period of 1 month