NCT05406323

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2023

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

June 2, 2022

Last Update Submit

May 6, 2025

Conditions

Keywords

fall preventionweb-based interventionelderlyFallingFear of Falling

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Change in The Falls Behavioral (FaB) Scale

    Pre, post (6 weeks), 3 months, 6 months

Study Arms (2)

Web-Based Fall Prevention Program Intervention

EXPERIMENTAL

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)

Behavioral: Web-Based Fall Prevention Program

Control Group

NO INTERVENTION

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.

Interventions

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.

Web-Based Fall Prevention Program Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Willing to participate in the study,
  • 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),

You may not qualify if:

  • 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..)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

Location

Study Officials

  • Nur Sema KAYNAR, MSc

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 6, 2022

Study Start

June 1, 2022

Primary Completion

December 30, 2022

Study Completion

July 14, 2023

Last Updated

May 7, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations