Study the effect of discharge plan training on adherence to treatment in mothers of children with nephrotic syndrome
Design
This is a randomized clinical trial with a parallel design and a control group. This non-blinded study will be performed on mothers of children with nephrotic syndrome. This randomized study will be performed on 50 eligible mothers. For randomization, a simple randomization method is used and participants are assigned to two groups of intervention and control.
Settings and conduct
This study, which will be performed at Namazi Hospital in Shiraz, is a non-blinded one. First, after providing oral explanations about the objectives of the study and the method of study, the demographic information questionnaire and the researcher-made questionnaire of adherence to treatment of mothers of children with nephrotic syndrome will be provided as a pre-test to participants in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The child does not have any other known physical disorder or illness; Motivation and desire of the mother to participate in the intervention; No other children and parents have nephrotic syndrome; Do not have a degree in medical sciences
Exclusion criteria: Mothers with severe physical illness or known psychological problems; Inability to access the Internet
Intervention groups
The intervention group will receive three virtual training sessions related to the discharge plan, each session lasting 20 minutes with an interval of 1 week.
The control group will not receive training and will only receive care, including routine nursing practices and training.
Main outcome variables
Adhere to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211214053408N1
Registration date:2022-01-03, 1400/10/13
Registration timing:prospective
Last update:2022-01-03, 1400/10/13
Update count:0
Registration date
2022-01-03, 1400/10/13
Registrant information
Name
Samira Montazeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3723 3234
Email address
smontazeri0@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of discharge plan training on adherence to treatment in mothers of children with nephrotic syndrome
Public title
Study the effect of discharge plan training on adherence to treatment in mothers of children with nephrotic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The child does not have any other known physical disorder or illness
Motivation and desire of the mother to participate in the intervention
No other children and parents have nephrotic syndrome
Do not have a degree in medical sciences
Exclusion criteria:
Mothers with severe physical illness or known psychological problems
Inability to access the Internet
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple random method, after identifying eligible persons, they will be randomly assigned a three-digit dedicated code. The last digit on the right determines the intervention or control group. If this number is 0, 1, 2, 3, 4, it will be assigned in the intervention group, and if this number is 5, 6, 7, 8, 9, it will be assigned 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 Shiraz University of Medical Sciences
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Namazi Square
City
Shiraz
Province
Fars
Postal code
91317 1198
Approval date
2021-05-08, 1400/02/18
Ethics committee reference number
IR.SUMS.REC.1400.171
Health conditions studied
1
Description of health condition studied
Pediatric Nephrotic Syndrome
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome
Primary outcomes
1
Description
Adhere to treatment
Timepoint
At the beginning of the study, immediately after the intervention and 1 month after the intervention
Method of measurement
Using a treatment adherence questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive three virtual training sessions related to the discharge plan, each session lasting 20 minutes with an interval of 1 week.
Category
Behavior
2
Description
The control group will not receive training and will only receive care, including routine nursing practices and training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Samira Montazeri
Street address
Zand St., Namazi Square, Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
smontazeri0@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Namazi Medical Center, Namazi Square, Zand St.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3235 7282
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
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
Samira Montazeri
Position
Nursing student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Namazi Square
City
Shiraz
Province
Fars
Postal code
913171198
Phone
+98 71 3647 4258
Email
smontazeri0@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Azita Jaberi
Position
Faculty member of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursing education
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Namazi Square
City
Shiraz
Province
Fars
Postal code
913171198
Phone
+98 71 3647 4258
Email
azita635@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samira Montazeri
Position
Nursing student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Namazi Square
City
Shiraz
Province
Fars
Postal code
913171198
Phone
+98 71 3647 4258
Email
smontazeri0@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD