NCT06754202

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

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

December 23, 2024

Last Update Submit

December 30, 2024

Conditions

Keywords

older peoplemild cognitive impairmentsocial farmingmontessori approach

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)

EXPERIMENTAL

Subjects with mild cognitive oimpairment (MCI) and self-sufficient in mobility that agreed to partecipate in various activities in rural enviroment.

Other: Social activities with cognitive stimulation

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.

Subjects with mild cognitive impairment (MCI)

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (2)

INRCA Hospital

Ancona, 60127, Italy

RECRUITING

INRCA Hospital

Fermo, 63900, Italy

RECRUITING

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.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Cristina Gagliardi, MsC

    IRCCS INRCA

    STUDY CHAIR

Central Study Contacts

Anna Rita Bonfigli, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: pre-post study
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

Locations