NCT07758478

Brief Summary

The aim of this study is to evaluate the effect of Montessori-based interventions on cognitive function and activities of daily living in older adults.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

August 24, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2026

Last Updated

August 11, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Activities, Daily LivingCognitive Function

Keywords

Older PeopleMontessoriCognitiveActivities, Daily Living

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in cognitive function, as measured by the Standardized Mini-Mental State Examination (SMMSE)

    This test consists of 11 items categorized under five main domains: orientation, registration, attention and calculation, recall, and language. The SMMSE is scored out of a maximum of 30 points, with one point awarded for each correct response. While a score of 23/24 is considered the cutoff point for dementia, SMMSE scores are further classified as 18-23 points indicating mild dementia, 10-17 points for moderate dementia, and 10 points or fewer representing severe dementia.

    Baseline, Week 8

  • Change from baseline in activities of daily living, as measured by the Barthel Index of Activities of Daily Living (ADL)

    The scale, consisting of 10 sub-domains that include activities such as feeding, bathing, personal grooming, dressing, toilet use, transfers, mobility, and stair climbing, measures the patient's level of independence and is generally preferred for individuals with motor and sensory impairments. Scoring ranges from 0 to 100, where a score of 0 signifies total dependence and a score of 100 signifies complete independence. The scores obtained from the scale are interpreted in terms of performing activities of daily living (ADLs) as follows: 0-20 points indicate "total dependence"; 21-61 points indicate "severe dependence"; 62-90 points indicate "moderate dependence"; 91-99 points indicate "mild dependence"; and a score of 100 is interpreted as "completely independent".

    Baseline, Week 8

Study Arms (2)

Montessori

EXPERIMENTAL

Prior to the study, participants will be provided with detailed information regarding the research, and written informed consent will be obtained from all volunteers. At baseline, initial data will be collected using a "Personal Information Form" and the "Barthel Index of Activities of Daily Living (ADL)". Subsequently, the experimental group will receive structured Montessori-based interventions tailored for nursing home residents. These application sessions will be conducted two days a week for a total duration of 8 weeks. Upon completion of the 8-week intervention period, post-test evaluations will be administered to measure the outcomes. This final assessment will include the re-administration of the "Barthel Index of ADL" to determine functional changes, alongside the "Standardized Mini-Mental State Examination (SMMSE)" or the "MMSE for the Uneducated", depending on the participant's educational level, to evaluate cognitive changes.

Other: Montessori

Control

NO INTERVENTION

Throughout the study, the control group will continue with routine nursing home activities.

Interventions

MontessoriOTHER

Prior to the study, participants will be provided with detailed information regarding the research, and written informed consent will be obtained from all volunteers. At baseline, initial data will be collected using a "Personal Information Form" and the "Barthel Index of Activities of Daily Living (ADL)". Subsequently, the experimental group will receive structured Montessori-based interventions tailored for nursing home residents. These application sessions will be conducted two days a week for a total duration of 8 weeks. Upon completion of the 8-week intervention period, post-test evaluations will be administered to measure the outcomes. This final assessment will include the re-administration of the "Barthel Index of ADL" to determine functional changes, alongside the "Standardized Mini-Mental State Examination (SMMSE)" or the "MMSE for the Uneducated", depending on the participant's educational level, to evaluate cognitive changes.

Montessori

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being 65 years of age or older
  • Having a Mini-Mental State Examination (MMSE) score of 18 or higher
  • Voluntarily agreeing to participate in the study

You may not qualify if:

  • Having a history of severe orthopedic or neurological disorders (e.g., stroke, Parkinson's disease, advanced osteoporosis)
  • Having severe sensory impairments (e.g., advanced vision or hearing loss)
  • Having severe physical activity restrictions due to cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu

Kastamonu, Turkey (Türkiye)

Location

Related Publications (5)

  • Sun, X., Sun, Z., & Ma, H. (2022). Effect of Montessori method on the cognitive and behavioral intervention of senile dementia patients: A meta-analysis. Aging Communications, 4(2), 7.

    BACKGROUND

  • Malone, M. L., & Camp, C. J. (2007). Montessori-based dementia programming®: Providing tools for engagement. Dementia, 6(1), 150-157.

    BACKGROUND

  • Sheppard CL, McArthur C, Hitzig SL. A Systematic Review of Montessori-Based Activities for Persons With Dementia. J Am Med Dir Assoc. 2016 Feb;17(2):117-22. doi: 10.1016/j.jamda.2015.10.006. Epub 2015 Nov 14.

    PMID: 26589532BACKGROUND

  • Feng, Y., van Reijmersdal, R., Yu, S., Rauterberg, M., Hu, J., & Barakova, E. (2018). Dynamorph: Montessori inspired design for seniors with dementia living in long-term care facilities. In Intelligent Technologies for Interactive Entertainment: 9th International Conference, INTETAIN 2017, Funchal, Portugal, June 20-22, 2017, Proceedings 9 (pp. 49-58). Springer International Publishing.

    BACKGROUND

  • Camp CJ. Origins of Montessori Programming for Dementia. Nonpharmacol Ther Dement. 2010;1(2):163-174.

    PMID: 23515663BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Semanur Çelik Demiryürek, Master of Science

CONTACT

+905394004408semanur.demiryurek@gazi.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was designed as a randomized controlled experimental study with a pre-test/post-test design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start (Estimated)

August 24, 2026

Primary Completion (Estimated)

October 19, 2026

Study Completion (Estimated)

October 19, 2026

Last Updated

August 11, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)