- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352387
Montessori Based Activities for Dementia
April 16, 2020 updated by: Dr. Helen YL Chan, Food and Health Bureau, Hong Kong
Effects of a Culturally Adapted Group Based Montessori Based Activities on Engagement and Affect in Chinese Older People With Dementia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
People who were aged 60 years or over and with mild to moderate dementia were recruited from six community centres and three care homes.
Participants were randomly assigned to either the intervention group to attend the Montessori-based activities or the comparison group to attend the conventional group activities for one hour twice per week over eight weeks.
All sessions were videotaped to facilitate analysis.
Observations of engagement and affect were conducted for each intervention session on the individual participant for a ten-minute period at the beginning, middle, and end of the activity in order to have observations from multiple time points.
The Menorah Park Engagement Scale and the Apparent Affect Rating Scale were used to assess the engagement and affect during the activities based on observations.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- The Salvation Army, Hong Kong and Macau Command
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- with a diagnosis of dementia at a stage 3 to 5 on the global deterioration scale (GDS)
Exclusion Criteria:
- were joining any other dementia training activities
- would highly likely present a hazard to others through disruptive behaviors
- proxy consent could not be obtained
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Montessori Method for Dementia
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.
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The Montessori Method highlights the importance of considering the past experiences, identifying interests and maximizing spared capacity and abilities of each individual.
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Active Comparator: Usual care
Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.
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Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement between the 1st minute - 10th minute of each session
Time Frame: through study completion for 8 weeks
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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.
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through study completion for 8 weeks
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Engagement between the 25th minute - 35th minute of each session
Time Frame: through study completion for 8 weeks
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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.
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through study completion for 8 weeks
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Engagement between the 50th minute - 60th minute of each session
Time Frame: through study completion for 8 weeks
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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.
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through study completion for 8 weeks
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Affect between the 1st minute - 10th minute of each session
Time Frame: through study completion for 8 weeks
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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
Time Frame: through study completion for 8 weeks
|
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
Time Frame: through study completion for 8 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Helen Chan, PhD, Chinese University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2018
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
April 15, 2020
First Submitted That Met QC Criteria
April 16, 2020
First Posted (Actual)
April 20, 2020
Study Record Updates
Last Update Posted (Actual)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 16, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SA2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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