Designing, applying, and evaluating the effectiveness of using a self-care application in children with cystic fibrosis
Design
Two arm parallel group randomized trial, on 88 patients, simple randomization using coins
Settings and conduct
Design phase:
In the first step, the researcher will determine the validity of its scientific content.
Implementation phase:
In the intervention group, the desired application is installed on the smartphone of children with CF. Before the installation, the self-care questionnaire for patients with Baker's cystic fibrosis and the demographic characteristics questionnaire are completed by the participants.
Evaluation phase:
After one month, the self-care questionnaire for patients with Baker's cystic fibrosis is completed by the control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Children aged 11 to 20 willing to participate in the study
- Membership in CF Iran Foundation
- Access to a mobile phone and ability to use the Android operating system
- Ability to read and write
Exclusion criteria:
- Having hearing, touch, and vision disorders
- Simultaneous participation in another similar training program
Intervention groups
The research was conducted on 88 people with cystic fibrosis between the ages of 11 and 20 who were assigned to two age-matched intervention and control groups of 44 people, and the trial intervention, the use of a mobile application designed for self-care training, in the intervention group for one month will be done. The control group was age-matched with the intervention group.
Main outcome variables
improve self-care; increased life expectancy; increase life expectancy; Increase the quality of life
General information
Reason for update
Acronym
CFA
IRCT registration information
IRCT registration number:IRCT20230717058812N1
Registration date:2023-09-11, 1402/06/20
Registration timing:prospective
Last update:2023-09-11, 1402/06/20
Update count:0
Registration date
2023-09-11, 1402/06/20
Registrant information
Name
Mahtab Yousefian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 5565
Email address
mahtabusefian95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Mobile Application Effectiveness on Self-care of Children with Cystic Fibrosis
Public title
Effect of Using Mobile Application on Improving Self-care of Children with Cystic Fibrosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 11 to 20 who want to participate in the study
Membership in Iran CF Foundation
Access to a mobile phone and the ability to use the Android or IOS operating system
Ability to read and write
Exclusion criteria:
Having hearing, touch and vision disorders that make it impossible to gather information
Simultaneous participation in another similar training program
Age
From 11 years old to 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The research units were patients who were matched in pairs in terms of age. Then, each pair was assigned to two intervention and control groups by a simple random allocation method with a coin.
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 children's medical center-Tehran university of medical sciences
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-10-19, 1401/07/27
Ethics committee reference number
IR.TUMS.CHMC.REC.1401.136
Health conditions studied
1
Description of health condition studied
Cystic fibrosis
ICD-10 code
E84.9
ICD-10 code description
Cystic fibrosis, unspecified
Primary outcomes
1
Description
Baker's Cystic Fibrosis Self-care Practice Instrument score
Timepoint
Before intervention and one month after intervention
Method of measurement
Baker's Cystic Fibrosis Self-care Practice Instrument
Secondary outcomes
1
Description
Baker's Cystic Fibrosis Self-care Practice Instrument score
Timepoint
Before intervention and one month after intervention
Method of measurement
Baker cystic fibrosis self-care practice questionnaire
Intervention groups
1
Description
Intervention group: using the self-care application for cystic fibrosis children, after the entry of people who meet the entry criteria and obtaining written informed consent, with the help of a random number table, these people are divided into two intervention and control groups. In the intervention group, the desired application is installed on the smartphone of children with CF. Before the installation, the self-care questionnaire for patients with Baker's cystic fibrosis and the demographic characteristics questionnaire are completed by the participants. Then this application is used by this group for one month. Before the test of the written informed consent form, the demographic information questionnaire will be provided to the control and intervention groups. After one month, a self-care questionnaire for patients with Baker's Cystic Fibrosis is completed by the control and intervention groups, and the data collected in the pre-test and post-test stages are entered into the SPSS version 22 software and using descriptive and inferential statistics of the case The analysis will be placed.
Category
Treatment - Devices
2
Description
Control group: not using the self-care application of cystic fibrosis children, the control group will also receive the usual training. It should be noted for to prevent the contamination of the control group samples, the desired application will be installed by the researcher and specifically with the help of each person's code on the phones of the intervention group. In order to comply with the ethical principles, after the end of the study, the application will be given to the people of the control group.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran CF foundation
Full name of responsible person
Mohamadreza Modaresi
Street address
Iran cf foundation, Forsate-Shirazi St.,Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
modaresipul@gmail.com
Web page address
http://cfiran.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrazad Ghiathundian
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 5565
Fax
+98 21 6690 4252
Email
fnm@tums.ac.ir
Web page address
http://fnm.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran CF Foundation
Proportion provided by this source
80
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Batool Pouraboli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4411
Fax
+98 21 6690 4252
Email
b.pouraboli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Batol Pouraboli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4411
Fax
+98 21 6690 4252
Email
b.pouraboli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Batol Pouraboli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4411
Fax
+98 21 6690 4252
Email
b.pouraboli@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
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
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
Year 1402-1403
To whom data/document is available
Doctors, nurses and specialists in the field of cystic fibrosis
Under which criteria data/document could be used
For more comprehensive studies, obtain permission from the responsible person
From where data/document is obtainable
Tehran University of Medical Sciences Faculty of Nursing and Midwifery Library
What processes are involved for a request to access data/document
Membership in the library of the Faculty of Nursing and Midwifery of Tehran University of Medical Sciences