- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05406323
Web-Based Fall Prevention Program for Elderly
The Effect of Web - Based Fall Prevention Program on Fall, Fall Risk and Fall Fear Among Elderly
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research was planned as a experimental design with a pretest- posttest control group design. It will be with individuals over the age of 65. The sample size of the research is consists of 72 people who agreed to participate in the research. Participant will be randomly assigned to the experimental and control groups via computer programı (random.org).
The research will be conduct on a web-based basis.The six-week web-based program includes health education, exercise and safe home environment initiatives.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nur Sema KAYNAR, MSc
- Phone Number: 27357 +90 (212) 404 03 00
- Email: nursemakaynar1@gmail.com
Study Contact Backup
- Name: Selda SECGINLI, PhD
- Email: secginli@iuc.edu.tr
Study Locations
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-
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Istanbul, Turkey, 34000
- Istanbul University- Cerrahpasa
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Contact:
- Nur Sema KAYNAR, MSc
- Phone Number: 27357 +90 (212) 404 03 00
- Email: nursemakaynar1@gmail.com
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Contact:
- Selda SECGINLI, PhD
- Email: secginli@iuc.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Willing to participate in the study,
- 65 years or older,
- Completing the Timed Up and Go (TUG) test for 12 seconds or more,
- Having internet access and the ability to use communication tools such as computers, tablets or smartphones,
- Not dependent on bed,
- Without moderate and severe cognitive impairment (Mini Mental State Test-MMD ≥24),
Exclusion Criteria:
- Illiterate,
- Visually impaired,
- Physical condition or disease that may prevent exercise (Multiple Sclerosis, Parkinson, with a fracture, artificial knee- hip-joint in the last six months etc..)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Web-Based Fall Prevention Program Intervention
Participants in this group will receive a 6-week Web-Based Fall Prevention Program intervention, comprising of health education, exercise and safe home environment.
Web-Based Fall Prevention Program will be conducted on web based (Web - Based Fall Prevention Program website)
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Health education: This intervention consisted of seven health issues which are "Fall among elderly", "fall risk factors", " fall prevention interventions-exercise", " fall prevention interventions-healthy diet", " fall prevention interventions- drug use", "fall prevention interventions- vision", "fear of falling". Exercise: This intervention is the exercise that is a combination of balance and strengthening exercises (8 exercise). Participants will do the exercises at least three days a week (along 6 week). Safe home environment: This intervention is aimed at providing a fall-safe home environment for the participants. In this context, the participants will watch the video on creating a safe home environment for falling. Participants will also be asked to answer the "Home Safety Check Form for Falls" to make their home more fall-proof. In this form, according to the answers given by the participants, suggestions will be given to prevent the risks of falling in the home environment. |
No Intervention: Control Group
The control group will not receive any intervention during the study.
Participants in the control group will take the same program after the study is complete.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of falls
Time Frame: Pre, post (6 weeks), 3 months, 6 months
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Participants will be asked about the number of falls in the past 12 months
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Pre, post (6 weeks), 3 months, 6 months
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Change in Fall Risk
Time Frame: Pre, post (6 weeks), 3 months, 6 months
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Simple screening test that is a sensitive and specific measure of probability for falls among older adults.
An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
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Pre, post (6 weeks), 3 months, 6 months
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Change in Falls Efficacy Scale (FES)
Time Frame: Pre, post (6 weeks), 3 months, 6 months
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Falls Efficacy Scale (FES) was developed to assess individuals' fear of falling.
It consists of 10 items.
The items are answered with yes or no.
An increase in the individual's fear of falling mean score means that the fear of falling increases.
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Pre, post (6 weeks), 3 months, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in The Falls Behavioral (FaB) Scale
Time Frame: Pre, post (6 weeks), 3 months, 6 months
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It has 30 items and 10 dimensions, and it is designed to identify an older person's awareness of-and practice of-behaviors that could potentially protect the individual from falling.
The 10 behavioral dimensions were cognitive adaptations, protective mobility, avoidance, awareness, pace, practical strategies, displacing activities, being observant, changes in level, and getting to the phone.
Items of the scale are based on self-reporting and were scored from 1 (never) to 4 (always), with 0 for does not apply.
Increases in subscales' mean scores indicate the individual is making safe behavioral changes or not taking risky behaviors.
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Pre, post (6 weeks), 3 months, 6 months
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Collaborators and Investigators
Investigators
- Study Chair: Nur Sema KAYNAR, MSc, Istanbul University - Cerrahpasa (IUC)
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IUC-YYU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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