NCT04352387

Brief Summary

The objectives of this study are to examine the feasibility of a culturally-adapted group-based Montessori Method for Dementia program in Chinese community and examine its effects on engagement and affect in community-dwelling people with dementia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

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

August 24, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

April 15, 2020

Last Update Submit

April 16, 2020

Conditions

Keywords

person-centeredcommunity support

Outcome Measures

Primary Outcomes (6)

  • Engagement between the 1st minute - 10th minute of each session

    Score of Menorah Park Engagement Scale will be used to assess the level of engagement, with the minimum score of 0 and the maximum of 2, with a higher score higher level of engagement.

    through study completion for 8 weeks

  • Engagement between the 25th minute - 35th minute of each session

    Score of Menorah Park Engagement Scale will be used to assess the level of engagement, with the minimum score of 0 and the maximum of 2, with a higher score higher level of engagement.

    through study completion for 8 weeks

  • Engagement between the 50th minute - 60th minute of each session

    Score of Menorah Park Engagement Scale will be used to assess the level of engagement, with the minimum score of 0 and the maximum of 2, with a higher score higher level of engagement.

    through study completion for 8 weeks

  • Affect between the 1st minute - 10th minute of each session

    Score of the Apparent Affect Rating Scale will be used to assess the level of affect, with 1 (Never) to 5 (over 5 minutes), in the aspect of pleasure and interest.

    through study completion for 8 weeks

  • Affect between the 25th minute - 35th minute of each session

    Score of the Apparent Affect Rating Scale will be used to assess the level of affect, with 1 (Never) to 5 (over 5 minutes), in the aspect of pleasure and interest.

    through study completion for 8 weeks

  • Affect between the 50th minute - 60th minute of each session

    Score of the Apparent Affect Rating Scale will be used to assess the level of affect, with 1 (Never) to 5 (over 5 minutes), in the aspect of pleasure and interest.

    through study completion for 8 weeks

Study Arms (2)

Montessori Method for Dementia

EXPERIMENTAL

The design of the Montessori Method for Dementia program covered five aspects, namely cognitive stimulation, life skills, motor movements and fitness, sensory stimulation, and socialization. Each 1-hour session included two to three activities tailored to the local cultural context.

Behavioral: Montessori Method for Dementia

Usual care

ACTIVE COMPARATOR

Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.

Behavioral: Usual care

Interventions

The Montessori Method highlights the importance of considering the past experiences, identifying interests and maximizing spared capacity and abilities of each individual.

Montessori Method for Dementia
Usual careBEHAVIORAL

Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.

Usual care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • with a diagnosis of dementia at a stage 3 to 5 on the global deterioration scale (GDS)

You may not qualify if:

  • were joining any other dementia training activities
  • would highly likely present a hazard to others through disruptive behaviors
  • proxy consent could not be obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Salvation Army, Hong Kong and Macau Command

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Chan HY, Yau YM, Li SF, Kwong KS, Chong YY, Lee IF, Yu DS. Effects of a culturally adapted group based Montessori based activities on engagement and affect in Chinese older people with dementia: a randomized controlled trial. BMC Geriatr. 2021 Jan 7;21(1):24. doi: 10.1186/s12877-020-01967-0.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Helen Chan, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Two research assistants who conducted the observations were blinded to the group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 20, 2020

Study Start

August 24, 2018

Primary Completion

July 31, 2019

Study Completion

December 31, 2019

Last Updated

April 20, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations