FallsNCT07890688
Evaluation of the Effectiveness of Vision Care in Preventing Falls in Hospitalized Patients
A study testing Vision Care in people with Falls and Ulcer, Pressure, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
The purpose of this randomized controlled trial is to evaluate the effectiveness of the Vision Care system in preventing falls among hospitalized patients. The study will compare the incidence of falls among patients receiving usual care with that among patients monitored using the Vision Care system during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Falls, Ulcer, Pressure
- What is being tested?
- Vision Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Hospitalization in the C0 inpatient unit of Hospital de la Santa Creu i Sant Pau for any medical reason during the 6-month study recruitment period.
Who cannot join
- Patients who, due to their clinical, functional, or cognitive condition, do not have a risk of falling because they are unable to move around the hospital room or transfer from the bed to a chair.
- Patients who do not provide informed consent
About this study
Official title: Randomized Controlled Trial to Evaluate the Effectiveness of the Vision Care System in Preventing Falls in Hospitalized Patients
The purpose of this randomized controlled trial is to evaluate the effectiveness of the Vision Care system in preventing falls among hospitalized patients. The study will compare the incidence of falls among patients receiving usual care with that among patients monitored using the Vision Care system during hospitalization.
- Conditions
- Falls, Ulcer, Pressure
- Being tested
- Vision Care
- Keywords
- Hospital falls, Fall prevention, Patient safety
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision CareDevice
Vision Care is an automated patient monitoring system designed to support the prevention of falls in hospitalized patients. The system uses an optical sensor installed in the patient's hospital room to continuously monitor patient movements and posture. When predefined movements or postures associated with a potential risk of falling are detected, the system generates an alert that is transmitted to the nursing staff through a mobile device (PDA), allowing them to assess the patient and take appropriate preventive measures. The system is used in addition to usual clinical care and standard fall prevention measures.
| Study group | Role | What they receive |
|---|---|---|
| Vision Care | Experimental | Participants will receive usual clinical care and monitoring using the Vision Care system during hospitalization. The system continuously monitors patient movements and posture and generates alerts for healthcare staff when predefined movements or postures associated with a potential risk of falling are detected. Receives: Device: Vision Care |
| Usual Care | No intervention | Participants will receive usual clinical care and standard fall prevention measures according to the hospital's usual practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of falls during hospitalization
Number of falls occurring during hospitalization, according to the study definition of a fall. A fall is defined as an event resulting from an incident that causes a person to unintentionally come to rest on the ground or another lower level, including slips, trips, and loss of balance.
Measured: Through all the length of stay in the inpatient unit for each participant. From admission until discharge from the inpatient unit. Unit stay average of 11 days.
Secondary outcomes (6)
Incidence of pressure ulcers
Occurrence of pressure ulcers of any stage during hospitalization, according to the classification system used by the hospital.
Measured: Through all the length of stay in the inpatient unit for each participant. From admission until discharge from the inpatient unit. Unit stay average of 11 days.
Length of hospital stay
Number of days from hospital admission to discharge from the inpatient unit.
Measured: From admission until discharge from the inpatient unit. Unit stay average of 11 days.
Healthcare professionals' satisfaction with the Vision Care device
Healthcare professionals' perceived usability, acceptability, and satisfaction with the use of the Vision Care device, assessed using an ad hoc brief questionnaire with 8 questions and a likert scale from 1 to 5 where higher scores mean better.
Measured: At study completion, estimated at 6 months after recruitment initiation
Time to first fall
Time in days from hospital admission to the first fall during hospitalization.
Measured: Through all the length of stay in the inpatient unit for each participant. From admission until discharge from the inpatient unit. Unit stay average of 11 days.
Performance of the Vision Care device
Assessment of the performance of the Vision Care device, including the number and type of alerts generated by the system, and response time to alerts.
Measured: Through all the length of stay in the inpatient unit for each participant. From admission until discharge from the inpatient unit. Unit stay average of 11 days.
Safety of the Vision Care device
Assessment of the safety of the Vision Care device, including true positive alerts, false positive alerts and false negative alerts.
Measured: Through all the length of stay in the inpatient unit for each participant. From admission until discharge from the inpatient unit. Unit stay average of 11 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890688
- Sponsor's protocol ID
- IIBSP-KEP-2025-145
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No