The aim of this study was to determine the effect of fall prevention education video on the occurrence of fall and fear of it (fall) in the elderly hospitalized
Design
A clinical trial with a control group with parallel, randomized groups on 132 patients that will be used for randomization from https://www.Randomization.com
Settings and conduct
This study will be performed in Shahid Beheshti Hospital in Qom on the elderly who meet the inclusion criteria. The fall prevention education video will be shown to the experimental group using the researcher's phone and the fall incident and fear of falling questionnaires will be used to assess the impact of the intervention. Blinding will be provided to researchers, outcome evaluators, and data analysts
Participants/Inclusion and exclusion criteria
Inclusion criteria including age over 60 years, functional dependence, ability to walk and move in the ward, no psychological memory impairment, ability to communicate and speak in Persian, no history of participation in fall prevention education programs, length of hospital stay From a week and at least once a history of falls before hospitalization
Exclusion criteria also include death, exacerbation of the disease, or transfer from the ward
Intervention groups
For the experimental group, the intervention in the form of two short training videos is less than 15 minutes in total about the fall. There is no intervention for the control group and it receives the usual training of the department. In order to observe the ethics in the research and if the intervention is effective, the educational video will be provided to the control group via WhatsApp
Main outcome variables
fall occurrence and fear of it
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210910052427N1
Registration date:2021-09-17, 1400/06/26
Registration timing:prospective
Last update:2021-09-17, 1400/06/26
Update count:0
Registration date
2021-09-17, 1400/06/26
Registrant information
Name
Nasrin Valieiny
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3776 8937
Email address
nasrin.valieiny1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-02-18, 1400/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Fall Prevention Education with Video on Fall Occurrence and Fear of it (Fall) among Older Hospital Inpatients
Public title
The Effect of Fall Prevention Education with Video on the Occurrence of Fall and Fear of it (Fall) in Hospitalized Elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 60 years of age
Patients who have the ability to walk and move in the ward
Patients who have the ability to communicate and speak in Persian
Patients who have at least one history of falls before hospitalization
Patients who have been hospitalized for more than a week
Exclusion criteria:
Patients with functional dependence
Patients with psychological memory impairment
Patients who have a history of participating in fall prevention education programs
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
the samples are allocated by the block random allocation method in two groups of control and intervention. Depending on the sample size, 33 blocks of 4 are required for random allocation. The intervention group will be displayed with A and the control group with B. The website https://www.Randomization.com will be used to randomly determine the blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to hide the random allocation from the researcher, a dark envelope sample size is prepared and each of the random sequences created is recorded on a card and placed inside the envelope. At the beginning of the registration of individuals, according to the order of arrival of the samples, one of the envelopes is opened in order and the assigned group of that sample is specified
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working Group / Research Ethics Committee School of Nursing and Midwifery and School of Rehabilitati
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid Square, East Nosrat St., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-08-04, 1400/05/13
Ethics committee reference number
IR.TUMS.FNM.REC.1400.095
Health conditions studied
1
Description of health condition studied
fall occurrence and fear of it
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of Falling in the International Scale of Fall Efficiency
Timepoint
Before the start of the study, at the time of discharge, one and three months after discharge will be completed by the two control and test groups
Method of measurement
Questionnaire International Fall Efficiency Scale
Secondary outcomes
1
Description
Percentage of people who have fallen
Timepoint
Before the start of the study, at the time of discharge, one and three months after discharge will be completed by the two control and test groups
Method of measurement
Fall Questionnaire
Intervention groups
1
Description
Intervention group: The intervention in the form of two short educational videos is less than 15 minutes in total. In these videos, the patient gets acquainted with the importance of the fall and its prevalence, the consequences of the fall, the risk factors for the fall, and how to use these mobility devices, as well as how to adjust the risk factors. The film is provided to the intervention group with the help of the researcher's mobile phone
Category
Prevention
2
Description
Control group: The control group will not receive any intervention and will benefit from the usual training in the ward. But at the end of the study, in order to observe the ethics in the research and if the educational video is effective on the fall occurrence and the fear of it, this video will be provided to the control group via WhatsApp.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Nasrin Valieiny
Street address
Shahid Beheshti Blvd, Shahid Dr. Beheshti Educational Research and Treatment Center
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2855
Email
bmc@muq.ac.ir
Web page address
https://bmc.muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Geranmayeh
Street address
Tehran, Tohid Square, Nosrat Sharghi St, School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6691 4368
Fax
Email
nursing_intl@tums.ac.ir
Web page address
https://www.fnm.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
Shahzad Pashaeypoor
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Tohid Square, Nosrat Sharghi St, School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4207
Email
sh-pashaeipour@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahzad Pashaeypoor
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Tohid Square, Nosrat Sharghi St, School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4207
Email
sh-pashaeipour@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahzad Pashaeypoor
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Tohid Square, Nosrat Sharghi St, School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4207
Email
sh-pashaeipour@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, all the information obtained after completing the fall and fear of falling questionnaire and after not identifying people can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
All researchers working in academic and scientific institutes can use the results of this study without any preconditions
From where data/document is obtainable
Shahzad Pashaeipour, Associate Professor of Nursing, Department of Community Health Nursing and Elderly Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences 00989124913843
sh-pashaeipour@tums.ac.ir Postal code: 1419733171
What processes are involved for a request to access data/document
Without providing any specific documentation, the information will be available to them as soon as possible in the form of set instructions