Determining the effect of stepping on fall prevention program o quality of life, Fear of fall, and fall related behaviors in the elderly people referred to Selected health care centers in Shiraz
Design
This is a clinical trial study with a parallel control group, uses single blinding. The study population has been consisted of all elderly people referring to selected health centers in Shiraz. The sample size with considering 14% attrition rate, are 50 in each group. Samples are divided into two intervention and control groups with randomized block assignment with 4-block permutations.
Settings and conduct
After approving the plan at Shiraz University of Medical Sciences and receiving the relevant codes, all seniors who are referred to the relevant clinics are invited to participate in the research. The training content of the crash prevention program consists of 7 training sessions of 60-90 minutes. Meetings are held in groups in the conference room of selected clinics. Each session covers different aspects to reduce the risk of falling. After the intervention and two months after the intervention, the questionnaires were again filled in two groups.
Participants/Inclusion and exclusion criteria
Participants are the elderly who refer to selected health care centers, are aware of the time, place, and person, have not known mental illness, and are able to walk and not miss more than two training sessions.
Intervention groups
The intervention group participates in the 7 sessions of fall stepping on program, and the control group receives only routine care.
Main outcome variables
The independent variable is the stepping on fall prevention program and dependent variables are includes of quality of life, fear of fall and fall related behaviors.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190506043498N1
Registration date:2019-12-08, 1398/09/17
Registration timing:retrospective
Last update:2019-12-08, 1398/09/17
Update count:0
Registration date
2019-12-08, 1398/09/17
Registrant information
Name
Mrayam Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3620 1328
Email address
maryameb1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of stepping on fall prevention program, on quality of life, fear of fall, and fall related behaviors of the elderly people
Public title
the effect of stepping on fall prevention program, on quality of life, fear of fall, and fall related behaviors of the elderly people
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Older people who came to the health care centers because of a disease or follow up
willing to participate in the study
be aware of time and place and person
Able to walk independently
Exclusion criteria:
attending in similar previous studies
a known case of mental illness
Those who die during the study or do not continue the study process
Those who fill the questionnaire incompletely
Absence of more than 2 sessions at training sessions
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the subjects were randomly assigned to intervention and control groups by blocked randomization. At first, the permutations of the four blocks are numbered.Then, randomly, the number of permutations is selected and the ordering of individuals in groups is recorded in a table.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the participants in the study are unaware of which group they are located.
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
7th Floor, Central Building of Shiraz University of Medical Sciences, Zand Blvd, Shiraz,Iran
City
shiraz
Province
Fars
Postal code
713451978
Approval date
2019-01-23, 1397/11/03
Ethics committee reference number
IR.SUMS.REC.1398.038
Health conditions studied
1
Description of health condition studied
fall
ICD-10 code
Z91.81
ICD-10 code description
History of falling
2
Description of health condition studied
fear of fall
ICD-10 code
F40.233
ICD-10 code description
Fear of injury
3
Description of health condition studied
quality of life
ICD-10 code
Z73
ICD-10 code description
Problems related to life management difficulty
4
Description of health condition studied
fall related behaviors in elderly people
ICD-10 code
W19
ICD-10 code description
Unspecified fall
Primary outcomes
1
Description
Fear of fall
Timepoint
Before the intervention, immediately after the intervention and two months later.
Method of measurement
Falls Efficacy Scale
2
Description
Quality of life
Timepoint
Before the intervention, immediately after the intervention and two months later.
Method of measurement
Lipad Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group will participate in 7 training sessions of the stepping-on fall training program. Sessions are held in groups in the conference room of selected clinics for 90-60 minutes. Each session covers various aspects of risk factors for falls and ways to prevent them such as home modification, medication management, exercise and other related factors.
Category
Prevention
2
Description
Control group: receive routine care. However, at the end of the study, the educational content of the stepping-on educational program was provided to the control group in the format of the DVD
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza clinic
Full name of responsible person
Maryam Ebrahimi
Street address
Namazi Square, Zand Blvd. Shiraz
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7000
Email
emamreza@sums.ac.ir
2
Recruitment center
Name of recruitment center
Motahari polyclinic
Full name of responsible person
Maryam Ebrahimi
Street address
Motahari polyclinic,Namazi Sq, Shiraz, Fars Province
City
Shiraz
Province
Fars
Postal code
225549842655
Phone
+98 71 3612 1000
Email
motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
7th Floor، Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 7594
Email
vcrdep@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
Maryam Ebrahimi
Position
Student in geriatric nursing at master level
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Fatemeh(PBUH) Nursing and Midwifery School، Namazee Square، Shiraz، Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3620 1328
Fax
Email
maryameb1374@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sakineh Gholamzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Fatemeh Nursing and Midwifery School، Namazee Square، Shiraz، Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3234 6417
Email
sakinghsir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ebrahimi
Position
Student in geriatric nursing at master level
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Fatemeh Nursing and Midwifery School، Namazee Square
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3620 1328
Email
maryameb1374@gmail.com
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
A portion of the information, such as data on the main outcome can be shared.
When the data will become available and for how long
Access to data is available 6 months after the publication of the results
To whom data/document is available
Researchers working in academia and scientific institution
Under which criteria data/document could be used
Data will be used for similar study scientifically and with reference.
To access the data, they can email the respondent
From where data/document is obtainable
You can contact: maryameb1374@gmail.com
What processes are involved for a request to access data/document
Applicants can email the respondent and receive an answer within a week.
Comments
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