Silver Agri Age: Longevity, Intrinsic Capacity and Cognitive Impairment Into Farmlands and Natural Environments: Updating Contexts Following the "Montessori" Action
Silver Agri Ag
1 other identifier
interventional
12
1 country
2
Brief Summary
This project aims to enhance the intrinsic capacities of elderly individuals with mild cognitive impairment by promoting innovative activities based on the Montessori approach within the context of agricultural multifunctionality. By selecting a rural environment with educational characteristics, we aim to involve individuals with mild cognitive deficits and their families in a personalized therapeutic journey. Through various activities, including horticulture, pet therapy, occupational therapies, sensory and food laboratories, we stimulate cognitive and motor skills, promoting a healthy and balanced lifestyle
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2024
CompletedFirst Submitted
Initial submission to the registry
December 23, 2024
CompletedFirst Posted
Study publicly available on registry
December 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedDecember 31, 2024
December 1, 2024
1.2 years
December 23, 2024
December 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in the positive and negative affects
The PANAS (Positive and Negative Affect Schedule) produces two distinct dimensions of affect: Positive Affect (PA): Measures emotions like joy, interest, excitement, and enthusiasm and Negative Affect (NA): Measures emotions like fear, anger, sadness, and guilt. Participants rate each of the 20 items (10 for PA, 10 for NA) on a 5-point scale (from 1 = "Very slightly or not at all" to 5 = "Extremely"). The possible score range for both PA and NA is 10 to 50. Higher scores indicate higher levels of that particular affect Scores for each subscale are calculated by summing the ratings for the corresponding items.
At baseline and after 9 months
Study Arms (1)
Subjects with mild cognitive impairment (MCI)
EXPERIMENTALSubjects with mild cognitive oimpairment (MCI) and self-sufficient in mobility that agreed to partecipate in various activities in rural enviroment.
Interventions
The nine-month program will include social activities following the "Montessori" action in the context of the agricultural multifunctionality such as horticulture, pet therapy, occupational therapy, sensory labs, physical activity held three days a week for five hours each day.
Eligibility Criteria
You may qualify if:
- diagnosis of mild cognitive impairment (MCI);
- Mini Mental State Examination ≥ 24;
- ability and willingness to sign informed consent
You may not qualify if:
- Mini Mental State Examination \< 24;
- severe visual impairment;
- inability to walk without help or assistance, Tinetti's scale \<20
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istituto Nazionale di Ricovero e Cura per Anzianilead
- Regione Marchecollaborator
Study Sites (2)
INRCA Hospital
Ancona, 60127, Italy
INRCA Hospital
Fermo, 63900, Italy
Related Publications (1)
Gambella E, Lombardi L, Cicconi D, Raccichini A, Paciaroni L, Giuli C, Bonfigli AR, Fabbietti P, Pelliccioni G, Gagliardi C. The Silver Agri Age project in Italy: a Montessori-inspired social intervention with older adults with mild cognitive impairment. Single-group pre-post pilot study protocol. Front Public Health. 2025 May 16;13:1561263. doi: 10.3389/fpubh.2025.1561263. eCollection 2025.
PMID: 40453497DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cristina Gagliardi, MsC
IRCCS INRCA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2024
First Posted
December 31, 2024
Study Start
May 3, 2024
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
December 31, 2024
Record last verified: 2024-12