Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248723
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-12-27
Brief Title:
ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults
Sponsor:
University of Milano Bicocca
Organization:
University of Milano Bicocca
Study Overview
Official Title:
ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IN TeMPO
Brief Summary:
The goal of this interventional non-pharmacological study is to investigate the effects of a multi-domain intervention active intervention compared to that followed by normal clinical practice self-guided intervention in older adults The primary objective is whether these interventions can prevent functional and cognitive decline in at-risk subjects
The multi-domain interventions will include physical exercise a Mediterranean diet-based nutritional plan cognitive training regular medical check-ups oral hygiene treatments and counseling monitoring and counseling on visual and auditory abilities counseling on sleep hygiene and treatment control of cardiovascular metabolic and infectious risk factors adjustment of drug therapy suggestions for improving social interactions
The multi-domain interventions will include physical exercise a Mediterranean diet-based nutritional plan cognitive training regular medical check-ups oral hygiene treatments and counseling monitoring and counseling on visual and auditory abilities counseling on sleep hygiene and treatment control of cardiovascular metabolic and infectious risk factors adjustment of drug therapy suggestions for improving social interactions
Detailed Description:
The study is multicentric and will include 10 centers Patients will be enrolled either through their General Practitioners GPs which will then refer back to their reference centers or through the centers themselves
Patients will undergo a screening visit which will include a multi-faceted evaluation of cognitive function physical and functional efficiency and cardiovascular and cognitive decline risk factors Procedures to be carried out during the screening visit include
Collection of socio-demographic data age sex marital status cohabitation level of education social interactions clinical details medical and medication history and evaluation of inclusionexclusion criteria
Assessment of the degree of frailty through the Primary Care Frailty Index PC-FI
Assessment of the presence of increased risk of developing dementia through the Cardiovascular Risk Factors Aging and Incidence of Dementia CAIDE score
Assessment of cognitive performance through the General Practitioner assessment of COGnition GPCOG
Assessment of cognitive performance through the Rey Auditory Verbal Learning Test - immediate
Assessment of functional status by Short Physical Performance Battery SPPB tests
Nonverbal interference tests
Assessment of cognitive performance through the Rey Auditory Verbal Learning online version RAVL-T delayed
Collection of self-administered scales for cognitive performance assessment through the Test Your Memory - Italian TYM-I scale
Then eligible patients will be enrolled for the second active intervention phase of the study which will include a baseline visit and 3 follow-up visits at 6 12 and 18 months
During these visits primary and secondary endpoint outcomes will be collected according to protocol
Patients will undergo a screening visit which will include a multi-faceted evaluation of cognitive function physical and functional efficiency and cardiovascular and cognitive decline risk factors Procedures to be carried out during the screening visit include
Collection of socio-demographic data age sex marital status cohabitation level of education social interactions clinical details medical and medication history and evaluation of inclusionexclusion criteria
Assessment of the degree of frailty through the Primary Care Frailty Index PC-FI
Assessment of the presence of increased risk of developing dementia through the Cardiovascular Risk Factors Aging and Incidence of Dementia CAIDE score
Assessment of cognitive performance through the General Practitioner assessment of COGnition GPCOG
Assessment of cognitive performance through the Rey Auditory Verbal Learning Test - immediate
Assessment of functional status by Short Physical Performance Battery SPPB tests
Nonverbal interference tests
Assessment of cognitive performance through the Rey Auditory Verbal Learning online version RAVL-T delayed
Collection of self-administered scales for cognitive performance assessment through the Test Your Memory - Italian TYM-I scale
Then eligible patients will be enrolled for the second active intervention phase of the study which will include a baseline visit and 3 follow-up visits at 6 12 and 18 months
During these visits primary and secondary endpoint outcomes will be collected according to protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None