Montessori Based Activities for Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Montessori Method for Dementia
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring person-centered, community support
Eligibility Criteria
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
Sites / Locations
- The Salvation Army, Hong Kong and Macau Command
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Montessori Method for Dementia
Usual care
Arm Description
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.
Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04352387
First Posted
April 15, 2020
Last Updated
April 16, 2020
Sponsor
Food and Health Bureau, Hong Kong
Collaborators
The Salvation Army, Hong Kong and Macau Command
1. Study Identification
Unique Protocol Identification Number
NCT04352387
Brief Title
Montessori Based Activities for Dementia
Official Title
Effects of a Culturally Adapted Group Based Montessori Based Activities on Engagement and Affect in Chinese Older People With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Food and Health Bureau, Hong Kong
Collaborators
The Salvation Army, Hong Kong and Macau Command
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
person-centered, community support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Two research assistants who conducted the observations were blinded to the group allocation.
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Montessori Method for Dementia
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.
Intervention Type
Behavioral
Intervention Name(s)
Montessori Method for Dementia
Intervention Description
The Montessori Method highlights the importance of considering the past experiences, identifying interests and maximizing spared capacity and abilities of each individual.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.
Primary Outcome Measure Information:
Title
Engagement between the 1st minute - 10th minute of each session
Description
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.
Time Frame
through study completion for 8 weeks
Title
Engagement between the 25th minute - 35th minute of each session
Description
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.
Time Frame
through study completion for 8 weeks
Title
Engagement between the 50th minute - 60th minute of each session
Description
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.
Time Frame
through study completion for 8 weeks
Title
Affect between the 1st minute - 10th minute of each session
Description
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.
Time Frame
through study completion for 8 weeks
Title
Affect between the 25th minute - 35th minute of each session
Description
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.
Time Frame
through study completion for 8 weeks
Title
Affect between the 50th minute - 60th minute of each session
Description
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.
Time Frame
through study completion for 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Chan, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Salvation Army, Hong Kong and Macau Command
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33413153
Citation
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.
Results Reference
derived
Learn more about this trial
Montessori Based Activities for Dementia
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