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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05406323
Other study ID # IUC-YYU
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2023
Est. completion date July 2023

Study information

Verified date February 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact Nur Sema KAYNAR, MSc
Phone +90 (212) 404 03 00
Email nursemakaynar1@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Fall is one of the most common problems experienced by the elderly, is an important public health problem in many societies. Falls are one of the leading causes of fatal and non-fatal injuries in the elderly. An average of one-third of individuals aged 65 and over have a fall at least once each year. The research will be carried out on the web page that on fall prevention prepared within the scope of this project. The aim of this project is to assess the effect of Web-Based Fall Prevention Program on falling, fall risk and fear of fall.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date July 2023
Est. primary completion date May 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Web-Based Fall Prevention Program
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.

Locations

Country Name City State
Turkey Istanbul University- Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in number of falls Participants will be asked about the number of falls in the past 12 months Pre, post (6 weeks), 3 months, 6 months
Primary Change in Fall Risk 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. Pre, post (6 weeks), 3 months, 6 months
Primary Change in Falls Efficacy Scale (FES) 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. Pre, post (6 weeks), 3 months, 6 months
Secondary Change in The Falls Behavioral (FaB) Scale 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. Pre, post (6 weeks), 3 months, 6 months
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