Develop and assess an e-health intervention for preterm infant care using IPDAS standards
Design
The study is a randomized, double-blind, controlled trial. Parents of preterm infants will be randomly assigned using block randomization to either the intervention group (50) and the control group (50)
Settings and conduct
The study site is a hospital. blinding methods are used:
Clinical Caregiver
The identities of the infants and parents are concealed from the clinical caregiver, and the caregiver is unaware of their group assignments.
Participants
Both groups receive usual care, but the intervention group additionally benefits from an electronic health intervention. Neither group is aware of the other group's intervention. The aim is to investigate the effect of the intervention on the length of infant hospital stay, parental sense of parenting efficacy, and infant discharge readiness at three time points.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Preterm infants:
Gestational age less than 37 completed weeks of pregnancy
Absence of congenital anomalies, major physical illnesses, and neurological deficits
Parents of preterm infants:
Age over 18 years
Education level of high school or above
Having access to the internet
No history of previous babies being admitted to the NICU
Exit criteria:
Death of the infant during the study
Referral of the infant to other centers for treatment
Withdrawal of parents from participation in the study
Parents working in NICU
Intervention groups
The control group will consist of parents who receive standard education and care. The intervention group will receive, in addition to standard care, an e-health intervention
Main outcome variables
1: Length of stay of the preterm infant
2: Parenting competence of parents of these infants
3: Discharge preparedness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240604062001N1
Registration date:2024-06-11, 1403/03/22
Registration timing:prospective
Last update:2024-06-11, 1403/03/22
Update count:0
Registration date
2024-06-11, 1403/03/22
Registrant information
Name
sara Ghalane
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 148 5465
Email address
saraghalane@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation, and evaluation of a web based eHealth intervention to support parents in caring for premature infants
Public title
Investigating the effect of electronic health on the care of premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm infants admitted to the NICU with a gestational age of less than 37 completed weeks of pregnancy
Preterm infants admitted to the NICU without major congenital anomalies, physical illnesses, or neurological impairments
Parents of preterm infants admitted to the NICU who are older than 18 years of age
Parents of preterm infants admitted to the NICU who have a secondary education or higher
Parents of preterm infants admitted to the NICU who own a smartphone and have internet access
Parents of preterm infants admitted to the NICU with no prior NICU admissions for their previous infants
Exclusion criteria:
Death of the infant during the study
Referral of the infant to other centers for treatment
Withdrawal of parents from participation in the study
Parents working in NICU
Age
From 1 day old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The selected samples will be divided into two equal groups using the random block method of paired permutations. For this purpose, 50 blocks of the two combinations AB and BA will be randomly selected. Then the samples will be assigned to two groups A and B. This is done by first identifying all 4-block blocks that include two codes A and B (6 blocks), and then randomly selecting blocks with replacement using a random number table (15 blocks). The blocks are a 60-element sequence of codes A and B, each of which is randomly assigned to one of the control and intervention groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Since this research is conducted on human subjects, informed consent will be obtained from all participants to participate in the research. However, all research results will be reported in aggregate form without mentioning the identifying information of the participants. For blinding the clinical caregiver, the following procedure will be followed. The initial assessment, before assigning preterm infants and their parents to the control and intervention groups, will be performed by the attending physician and reported to the researcher. During the intervention, the names of all infants and their parents will be hidden and displayed to the clinical caregiver, and the attending physician will not have any information about their identities. During the three-month follow-up, the study-related assessment will also be performed and reported by the clinical caregiver. Since the names of the control and intervention groups are not available to the clinical caregiver, and they have no information about which group they belong to. The blinding procedure for participants is as follows: Both groups will receive the usual training and care (including educational pamphlets in the NICU and training by nurses), and the intervention group will additionally use an electronic health intervention. Neither group will have information about the nature of the training and care provided to the other group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of Kashan University of Medical Sciences
Street address
Department of Health Information Management, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2023-09-25, 1402/07/03
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1402.043
Health conditions studied
1
Description of health condition studied
Premature infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Length of stay of the preterm infant
Timepoint
from the time of entry into the study to discharge
Method of measurement
LOS is defined as the number of days a preterm infant is hospitalized in the NICU. It is extracted from the newborns' medical records.
2
Description
Parenting competence (self-efficacy and satisfaction) of parents of these infants
Timepoint
At three time points: entry into the study, one day before discharge, and three months after discharge
Method of measurement
Parenting Self-Efficacy Questionnaire
3
Description
Discharge preparedness
Timepoint
At three time points: entry into the study, one day before discharge, and three months after discharge
Method of measurement
Discharge preparedness checklist
Secondary outcomes
empty
Intervention groups
1
Description
The intervention includes the design and use of a website for preterm infant care, considering the "International Patient Decision Aid Standards (IPDAS)" and is used by parents of preterm infants for three months. Intervention group: Parents of preterm infants who use an electronic health intervention (website) in addition to usual care. The website includes various educational sections, including breastfeeding education, vaccination reminders, communication with the doctor, development, infant hygiene, and issues related to parents, including depression, etc
Category
Other
2
Description
Control group: The control group consists of parents who receive the usual training and care (including educational pamphlets in the NICU and training by nurses)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Sara Ghalane
Street address
Department of Health Information Management, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9006
Fax
+98 31 5558 9007
Email
saraghalane@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9006
Email
saraghalane@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Ehsan Nabovati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9006
Email
enabovati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ehsan Nabovati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9006
Email
enabovati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sara Ghalane
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Department of Health Information Management, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 937 148 5465
Fax
Email
saraghalane@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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