Determining of the effect of family-centered education on the level of performance and family burden at home
Design
Clinical trial, intervention and control group, randomized, single center, Sampling type: available eligibles, Segmentation: Random blocks with quadruple blocks
Settings and conduct
Place of study:Tehran University of Medical Sciences and Health Services
Participants/Inclusion and exclusion criteria
Inclusion criteria: Desire for participating in the study The patient is under invasive home mechanical ventilation The primary caregiver is the person who has the most involvement in the treatment The caregiver should be able to read and write at least Exclusion criteria: In case of participation in a study that interferes with the current study
Intervention groups
Intervention group: After obtaining informed consent and the completion of the researcher-made checklists, Home care training (routine and emergency) is given to the family in 5 sessions of 1 hour in 4 weeks.. Control group: After obtaining informed consent and the completion of the researcher-made checklists, They will receive routine intensive care training.
Main outcome variables
Family performance level, Family burden
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210205050252N1
Registration date:2021-03-04, 1399/12/14
Registration timing:prospective
Last update:2021-03-04, 1399/12/14
Update count:0
Registration date
2021-03-04, 1399/12/14
Registrant information
Name
پروانه Asgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6524 8931
Email address
p-asgari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family centered education in invasive home mechanical ventilation patients
Public title
Effect of family education at home
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Desire for participating in the study The patient is under invasive home mechanical ventilation The primary caregiver is the person who has the most involvement in the treatment The caregiver should be able to read and write at least
Exclusion criteria:
In case of participation in a study that interferes with the current study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sequence of random allocation and the list of blocks will be obtained by the statistical consultant with the help of software. The website http://www.sealedenvelipe.com is a useful site for generating random sequences for block type randomization. This site is designed in such a way that there is no limit on the number of groups for random allocation. Volume block method four is used to create random allocation sequences. Blocks consisting of two groups A and B randomly selected using the software such as (BAAB) ، (ABBA) ، (AABB) ، (BBAB). Then 60 pockets (30 pockets containing paper A and 30 pockets containing paper B) will be prepared based on sample size. According to a list of blocks, a trained person outside of the research team will be set the row of pockets. In the first stage, each patient will be randomly assigned to the A group (intervention) or B group (control). The sample process will be performed sequentially until the end of completion of sample size. Code of each patient will also be allocated to his family member. Patients are assigned to the study group in order of their entry into the study and randomly through randomized blocks. For example, according to the block (ABAB), each patient enters the intervention, control, intervention and control groups, respectively, after entering the study. This process continues until the last block is selected.
Blinding (investigator's opinion)
Double blinded
Blinding description
The assignment of the groups will be done by someone out of the study and the investigator won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Nursing and Midwifery and School of Rehabilitation, Tehran University
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.TUMS.FNM.REC.1398.114
Health conditions studied
1
Description of health condition studied
Performance skills and family burden
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Performance skills score in researcher-made checklists
Timepoint
Before and one week after education
Method of measurement
Researcher-made functional skills checklist
Secondary outcomes
1
Description
Family burden score
Timepoint
Three month after the intervention
Method of measurement
ZARIT burden questionnaire
Intervention groups
1
Description
After getting informed consent, the main family caregiver will receive routine and emergency care training including suction, gavage, skin care, and cardiopulmonary resuscitation via face to face and on a replica before the patient is discharged home. The duration of the training will be five one-hour training sessions. The mentioned training booklet will also be provided to the family.
Category
N/A
2
Description
In the control group, the main family member will receive routine intensive care unit training including suction, gavage and skin care in a brief training session during discharge.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Parvaneh Asgari
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
p-asgari@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Deputy of research and technology, Sixth floor, Central organization of university, Corner of Quds St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 3685 8163
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Asgari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
p-asgari@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Asgari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
p-asgari@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Asgari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
p-asgari@razi.tums.ac.ir
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