An interventional study of Vision Care in Falls and Ulcer, Pressure, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Prevention
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.
526 studies on the registry are indexed under Pressure Ulcer; 120 are open to participants now.
This study's planned enrollment of 530 is above the median of 70 across 401 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 342 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
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.
Device: Vision Care
Participants will receive usual clinical care and standard fall prevention measures according to the hospital's usual practice.
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.
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.
Time frame: 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.
Incidence of pressure ulcers
Occurrence of pressure ulcers of any stage during hospitalization, according to the classification system used by the hospital.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
Of 181 non-industry interventional studies with no phase under Pressure Ulcer, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 6 months is below that.
Counting every sponsor, half of 211 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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