The effect of Implementation of Multidisciplinary Program via Telecare on The Level of Quality of Life on of Children in School-age Involved with Cystic Fibrosis and Their Parents
Determining the effect of Implementation of Multidisciplinary Program via Telecare on The Level of Quality of Life on of Children in School-age Involved with Cystic Fibrosis and Their Parents
Design
A clinical trial with a control group, with parallel-group design, without blindness, randomized through a throw Coins
Settings and conduct
This study was conducted in the respiratory ward of mofid Hospitals and Children's Medical Center in Tehran. Samples randomly assigned to intervention and control groups. The samples of both groups completed the Revised Quality of Life cystic fibrosis questionnaire for parents and children. For the intervention group, the educational program was implemented through the application. The post-test was taken immediately and one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: consent to participate in research and having cooperation; children must be at least 12 and up to 18 years of age; ability to read and write; ability to work with smartphones and applications; access to android with mobile phones; no other child with cystic fibrosis and other diseases; parental physical and mental health.
Exclusion criteria: participation in previous same care program in Last three months; not wanting to continue treatment in the middle of it.
Intervention groups
Intervention group: in the intervention group, the educational program include:1. Understanding cystic fibrosis: defining the disease, the cause and how to diagnose the disease 2. Treatment and care: Including two parts lung and nutrition 3. Daycare focused care training Respiratory (respiratory physiotherapy, daily exercise, medications) and gastrointestinal care (diet, supplemental enzymes, and antibiotics) 4. How to communicate with the social worker (counseling) will be implemented. control group receives routine care.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190805044443N1
Registration date:2019-09-28, 1398/07/06
Registration timing:retrospective
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Maryam Alibakhshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6640 6886
Email address
m_alibakhshi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-09-19, 1398/06/28
Trial completion date
2019-09-19, 1398/06/28
Scientific title
The effect of Implementation of Multidisciplinary Program via Telecare on The Level of Quality of Life on of Children in School-age Involved with Cystic Fibrosis and Their Parents
Public title
The effect of Implementation of Multidisciplinary Program via Telecare on The Level of Quality of Life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children and parent with school-age children (6-12 years) with cystic fibrosis
Parent with ability to read and write
At least 6 months have passed since the definitive diagnosis of the disease
Mobile phone access with Android OS
Ability to work with smartphones and app
Parents should have physical and mental health based on self-expression
Exclusion criteria:
Unwillingness to continue caring in the middle
Participation in previous same care program in Last three months
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Actual sample size reached:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method was used for randomization. Firstly, all eligible patients were selected based on the criteria of entry and assigned a special code. Then, according to the sample size and the same number, the coin was thrown, and the heads subjects in the intervention group and the tails subjects in the 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
in front of Shahid Rajaee Heart Hospital, Intersection of Niayesh, Valiasr S
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-13, 1398/02/23
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.052
Health conditions studied
1
Description of health condition studied
Cystic Fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis
Primary outcomes
1
Description
Quality of Life
Timepoint
Before, immediately after and one month after intervention
Method of measurement
Revised Quality of Life cystic fibrosis questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the intervention group, the educational program include: 1. Understanding cystic fibrosis: defining the disease, the cause and how to diagnose the disease 2. Treatment and care: Including two parts lung and nutrition 3. Daycare focused care training Respiratory (respiratory physiotherapy, daily exercise, medications) and gastrointestinal care (diet, supplemental enzymes, and antibiotics) 4. How to communicate with the social worker (counseling) will be implemented
Category
Rehabilitation
2
Description
Control group: the control group will receive routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children's Hospital
Full name of responsible person
Maryam Alibakhshi
Street address
Shariati Street, Mofid children's Hospital
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir
Web page address
http://www.mch.sbmu.ac.ir/
2
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Maryam Alibakhshi
Street address
Dr. mohammad gharib Street, Children's Medical Center