Fall prevention in acute geriatrics, AI-based assistance system for monitoring mobility and fall events in geriatric patients
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients must be at least 70 years old at the time of inclusion. They must have an increased fall risk, as determined by clinical assessment, along with geriatric typical multimorbidity (at least three diseases) and polypharmacy (at least five active ingredients) after a fall event within the last 12 months. They must be able to walk at least 4 meters with or without aids, and their Mini-Mental Status Examination (MMSE) must be at least 18 points. Additionally, patients should have sufficient knowledge of the German language.
Exclusion criteria
Exclusion criteria: Patients with terminal-stage diseases or severe advanced dementia (MMSE < 18) are excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the SAVE&SAFE project is the reduction of psychosocial workload, documentation burden, and the improvement of work processes for nurses. Data collection will occur at four time points: t0 at the beginning of the control phase, t1 at the end of the control phase, t2 at the end of the transition phase, and t3 at the end of the intervention phase. Psychosocial relief effects will be assessed using the Copenhagen Psychosocial Questionnaire (COPSOQ). Data will be collected through standardized quantitative online surveys of the nurses at time points t0–t3. Real-time observations will be conducted on the work floor with anonymized data collection. A Time-Action Analysis will be performed using the Time Capture Tool (Time CAT) to capture documentation workload and time logs related to caregiving activities. Measurement will be conducted over 72 consecutive hours per quarter, starting in the first quarter of 2025 and continuing through the third quarter of 2026. To complement the collection of objective data, biosignals will be recorded, including brain activity using EEG and movement data through IMU systems. Additionally, events will be commented on using Think-Aloud protocols. These measurements will occur at time points t0 through t3 and will last between 30 minutes and 3 hours. Additionally, qualitative data will be collected through interviews with nurses about the effects and relief benefits of the new model of care (NVF). These interviews will be conducted using a guided interview format at time points t0 and t3. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include the frequency of subsequent falls after the intervention, changes in fear of falling, changes in gait instability, increases in patient enablement, changes in health-related quality of life, and patient and caregiver satisfaction with the care received. To collect the number of subsequent falls, existing fall logs for the participants in the clinic are recorded. In the home environment, participants are provided with pre-printed monthly fall logs, which are filled out by the participants themselves or their caregivers. Once a month, a telephone inquiry is conducted regarding the fall logs. The collection takes place at t0 = inclusion, t1 = end of the high-risk phase (after 3 months), and t2 = end of the follow-up phase (after 9-12 months). To assess fear of falling, the German version of the Falls Efficacy Scale-International (FES-I) is used. Data collection takes place face-to-face in the clinic at t0 and t1, and by telephone in the home environment at t2. Data is collected individually from the patients at t0, t1, and t2 = end of the follow-up phase (t0 + 9-12 months). To measure gait instability, the Short Physical Performance Battery (SPPB) is used to assess risks related to balance, walking speed, and leg strength. The assessment occurs only during the hospital stay, at t0 and t1. Patient enablement is measured using the PEN-13 (Patient Enablement Instrument), a 13-item instrument to assess patient capabilities. Data collection occurs face-to-face in the clinic at t0 and t1, and via telephone in the home environment at t2. To measure time expenditure and the associated satisfaction with the new care model (NVF), the eCare Client Impact Survey (eCCIS) is used. This questionnaire covers areas such as time investment, service impact, satisfaction, and willingness to pay for the new care model by patients and caregivers. The survey is only administered in the intervention group at time points t1 and t2. Data collection occu | — |
Countries
Germany
Contacts
St. Martinus Krankenhaus