Leader: Stefania Maggi (CNR); Other collaborator(s): All Spoke 8 Partners and possible participation of researchers from other Spoke
To evaluate the feasibility of personalized multidomain interventions to maintain functional capacity and prevent physical and cognitive decline among older adults living in LTCFs, the protocol for a multicenter RCT will be designed. Participants will be assigned to the multidomain intervention group, based on innovative technological solutions, or to the usual activities group. Multidomain interventions will be defined also taking into considerations the results from the literature review performed within task 3.1, and technological solutions will be selected and monitored with the support of experts working in the WP5. This task will also benefit from the support of WP4-task 4.5, which will provide methods to define predictive models to apply personalized multidomain interventions based on the individual subject’s need. Cost-effectiveness analyses will be evaluated in collaboration with WP6.
Brief description of the activities and of the intermediate results
The protocol for a multidomain intervention aiming to improve functional and cognitive wellbeing among older adults living in Long Term Care Facilities (LTCF) has been defined (I COUNT study). The main goal of the intervention is to determine the feasibility and the effect of multidomain intervention in older adults living in LTCFs, by comparison with a group of institutionalized older adults following usual care.
The study will be based on a parallel-group cluster randomized controlled trial; two LTCF were identified (Padua, Cremona) based on their capability to carry out the research activities and their structural comparability. A sample size of 60 individuals for each LTCF (30 in the intervention group, 30 in the control group) has been determined. Residents at 01.06.2024 will be recruited according to the defined inclusion/exclusion criteria.
Comprehensive baseline evaluation will be performed, and blood and stool samples will be obtained. The multidimensional intervention group will receive a 6-month physical exercise and cognitive training, and diet based on the Mediterranean diet pattern using also functional foods.
Vaccinations according to the National vaccination plan will be proposed to the participants of the intervention group. Technologies including accelerometers to monitor physical activity, minimally invasive wearable sensors to monitor vital parameters, apps to monitor falls' risk and sleep disturbances, and innovative software for cognitive training will be used. The control group will be asked to continue its usual activities in terms of physical and cognitive exercise and to follow the usual diet. Three follow-ups are planned, at three, six and nine months after the baseline assessment
The protocol of the study has been evaluated and approved by the Ethics Committee of the coordinating LTCF. We are now organizing training and technologies' tests, in order to start the field study in June 2024.
Main policy, industrial and scientific implications
To address the expected impact of biomarkers on efficacy of multi-intervention approach . These results will be useful in eventual ongoing modfification of clinical trials
The protocol for a multidomain intervention aiming to improve functional and cognitive wellbeing among older adults living in LTCF (I COUNT study) has been defined and approved by the Ethics Committees of the coordinating center (09/04) and the participating LTCFs (15/04). It was also submitted to and discussed with the Ethics Committee of Padua (06/06). The project was presented to the staff of the LTCFs and to potential participants. The study protocol was presented during the Age-It conference in Venice (22-24/05).
New technologies to be used in WP3, including fall detectors, photoplethysmography systems to assess stress during training sessions, and innovative surface electromyography systems to assess sarcopenia and fall risk, were discussed in collaboration with WP5 colleagues. The data needed to develop cost-effectiveness analyses were evaluated with WP6 colleagues, in collaboration with LTCFs’ staff.
The content of each physical and cognitive training session was defined by neuropsychologists and sport scientists. The feasibility of computer-based cognitive training for elderly patients with mild cognitive impairment or mild dementia was evaluated in Padua and Cremona hospitals.
Purchases of the different materials (pc, tablets, smartwatches, physical training equipment) needed for training were organized. Activities with the laboratories that will evaluate biomarkers and microbiota composition were under development.
The protocol for the I COUNT study has been definitely approved also by the Ethics Committees of Padua (09/06).
In collaboration with WP4 colleagues, the structure of the LISA website dedicated to Spoke 8 interventions was defined. New technologies to be used in WP3 were further discussed and tested in collaboration with WP5 colleagues.
Data collected to evaluate the feasibility of computer-based cognitive training for elderly patients with mild cognitive impairment or mild dementia were analyzed in collaboration with neuropsychologists from the University of Padua.
The purchase of other materials (whole-body tetrapolar bioelectric impedance system, electronic hand dynamometers) and services (biomarker analysis, blood and stool sample transport) needed for enrolment and training was organized.
Enrolment according to the defined inclusion/exclusion criteria will start on 01/11/2024.
The materials needed for enrolment and training (whole-body tetrapolar bioelectric impedance system, electronic hand dynamometers) were sent to the participating LTCFs, and testing and training were carried out with the manufacturers. The purchase of services (biomarker analysis, blood and stool sample transport) needed for enrolment and training was further organised.
The details of the laboratory analysis of routine and non-routine markers were defined together with the laboratory of the University Hospital of Padua.
In collaboration with WP4 colleagues, the structure of the LISA website was fully defined and the specific content for WP3 was prepared by different specialists (neuropsychologists, motor experts, geriatricians).
New technologies to be used in WP3 were further discussed and tested in collaboration with WP4 and WP5 colleagues and LTCF coordinators.
A manuscript on the study protocol was prepared for publication; a manuscript on the feasibility of a computer-based cognitive training for elderly patients with mild cognitive impairment or mild dementia is being prepared in collaboration with neuropsychologists from the University of Padua.
The study protocol was presented to the family members of the LTCF residents and the collection of informed consent started. Enrolment according to the defined inclusion/exclusion criteria will start on 03/02/2025.
OUTPUTS
Coming soon