Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversity of Milano Bicocca
About this trial
The aim of this study is to assess whether a multidomain, multidisciplinary intervention (MDI), enhanced by technological solutions, effectively improves the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty. Additionally, the study will evaluate the feasibility and acceptability of delivering these interventions remotely via technology after hospital discharge.
Participants will:
* Receive an MDI during their hospital stay and continue with remote at-home support for 3 months, or receive usual care. * Attend outpatient clinics for follow-up assessment at 3 and 6 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >70 years;
Mild to moderate frailty, defined by a panel of tools agreed upon by the group of researchers involved in the study (Primary Care Frailty Index [PC-FI] between 0.07 and 0.21, Clinical Frailty Scale [CFS] 4-6);
Ability to walk with or without assistance
Ability to communicate and cooperate with the research team;
Disqualifiers
Expected hospital stay duration <3 days;
Estimated prognosis quoad vitam <12 months;
Persistent clinical instability, indicated by a NEWS2 score >5 (assessed within 48 hours of admission) and/or the presence of delirium (4AT >4);
History of schizophrenia, major depression, bipolar disorder, or psychosis;
Trial design
Design model
Parallel
Treatments tested in this trial
Multidomain Interventions
Other interventionMultidomain Interventions The intervention group will receive a personalized MDI approach from a multidisciplinary team, including a digital coach, physiotherapist, clinical nutrition expert, neuropsychologist, geriatrician, and nurse. This approach will encompass physical activity program, nutritional interventions, cognitive training and stimulation, medication reconciliation, coaching on the use of technological supports, and group activities. Environmental modifications at home will also be proposed
Treatment groups
288 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Assess the effect of the MDI on motor function at discharge from the AGU
Effect of the intervention in terms of motor function, assessed using the Short Physical Performance Battery (SPPB, from 0 to 12)
Time frame
Baseline, Discharge (after an average hospital stay of 10 days)Secondary outcomes
1
Assess the effect of the MDI on readmissions at 6 months follow-up.
Effect of the MDI in reducing hospital readmissions at 6 months
Time frame
6 months2
Evaluate the participant adherence to the protocol
Evaluate the participant adherence to the protocol assessing the number of drop-out and overall retention rates
Time frame
6 months3
Evaluate the feasibility of home-based MDI with technological support
Feasibility of home-based MDI with technological support, evaluated using Patient Reported Experience Measures (PREMs), questionnaires measuring the patients' perceptions of their experience whilst receiving care
Time frame
3 months, and 6 months4
Assess the effect of the MDI on readmissions at 3 months follow-up.
Effect of the MDI in reducing hospital readmissions at 3 months
Time frame
3 monthsOther outcomes
1
Assess the impact of the MDI on cardiovascular risk factors.
Impact of MDI on lifestyle and inactivity, blood pressure, smoking, cholesterol level, and blood glucose.
Time frame
Baseline, 6 months2
Evaluate the effect of the MDI on participants&amp;amp;amp;#39; social relationships.
Effect of the MDI on improving social relationships, assessed using the Lubben Social Network Scale (12 items scale)
Time frame
3 months, 6 months3
Evaluate the impact of fortified food consumption on microbiota composition and bowel alterations in a subgroup of patients not undergoing antibiotic therapy (ancillary study).
Evaluation of the impact of fortified food consumption on faecal analysis in a subgroup of patients not undergoing antibiotic therapy
Time frame
Baseline, Through Discharge an Average of 10 days4
Assess participants access to (and frequency of use of) technological resources.
Number of app accesses.
Time frame
Through Discharge an Average of 10 days, 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov