NCT03750500

Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People

Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People - a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sword Health, SA · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, prospective, non-blind, parallel-group, randomized controlled trial with an experimental and a control group with the aim of evaluating the clinical impact of a home-based falls prevention program using a new biofeedback system on community-dwellers older adults with fall risk in comparison with standard of care. The experimental group will perform a 12-week exercise program at home, under remote monitoring from a clinical team, whereas the control group will benefit from standard medical care currently in place at the participating primary care facility. The hypothesis is that the home-based falls prevention program will lead to a lower risk of falling than standard medical care.

Conditions

• Fall

Interventions

Type	Name	Description
DEVICE	Biofeedback device	12-week exercise program performed through the device
BEHAVIORAL	Education on falls risk	Education on falls risk factors and how to minimize them
OTHER	Medication review	Medication will be reviewed to reduce sedative drugs and minimize interactions
DIAGNOSTIC_TEST	Visual and auditory screening	Patients will go through visual and auditory screening as part of their regular care

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2018-11-23
• Last updated: 2024-12-06

Locations

1 site across 1 country: Portugal