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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04352387
Other study ID # SA2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 24, 2018
Est. completion date December 31, 2019

Study information

Verified date April 2020
Source Food and Health Bureau, Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Montessori Method for Dementia
The Montessori Method highlights the importance of considering the past experiences, identifying interests and maximizing spared capacity and abilities of each individual.
Usual care
Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.

Locations

Country Name City State
Hong Kong The Salvation Army, Hong Kong and Macau Command Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
Food and Health Bureau, Hong Kong The Salvation Army, Hong Kong and Macau Command

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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