Multidomain Interventions for Elderly Individuals in Residential Structures (NCT06820710) | Clinical Trial Compass
CompletedNot Applicable
Multidomain Interventions for Elderly Individuals in Residential Structures
Italy90 participantsStarted 2025-02-03
Plain-language summary
The "Multidomain Interventions to improve the COgnitive and fUNctional well-being of elderly individuals in residential sTructures" (I-COUNT) study aims to test the feasibility and the effectiveness of a multidisciplinary intervention among elderly individuals living in long term care facilities (LTCFs). The intervention will include selected physical and cognitive training activities administered and monitored by new technologies, a dietary intervention including also functional foods, and the administration of vaccines according to the National plan. The multidomain intervention will last 6 months and will be compared with the standard care adopted in the same LTCFs.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age ≥70 years;
* resident in the identified LTCFs for at least 6 months;
* able to communicate and collaborate with the research team;
* Mini-Mental State Examination-MMSE ≥18.
Exclusion Criteria:
* estimated length of stay in the LTCFs\<6 months;
* estimated life expectancy \<6 months;
* previous gastrectomy or colectomy;
* presence of a nasogastric tube or percutaneous endoscopic gastrostomy (PEG);
* presence of dysphagia;
* inability to undergo psychometric tests for any reason;
* history of psychiatric illness according to clinical anamnesis;
* inability to walk.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of the multidomain intervention on the gut microbiota composition
Timeframe: Baseline and 3 months after the start of the intervention
2
Effect of the multidomain intervention on the gut microbiota composition
Timeframe: Baseline and 3 months after the start of the intervention
3
Effect of the multidomain intervention on the gut microbiota composition
Timeframe: Baseline and 3 months after the start of the intervention
Trial details
NCT IDNCT06820710
SponsorIstituto di Neuroscienze Consiglio Nazionale delle Ricerche