Montessori Based Activities for Dementia

Sponsor
Food and Health Bureau, Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT04352387
Collaborator
The Salvation Army, Hong Kong and Macau Command (Other)
108
1
2
16.2
6.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Montessori Method for Dementia
  • Behavioral: Usual care
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Two research assistants who conducted the observations were blinded to the group allocation.
Primary Purpose:
Supportive Care
Official Title:
Effects of a Culturally Adapted Group Based Montessori Based Activities on Engagement and Affect in Chinese Older People With Dementia
Actual Study Start Date :
Aug 24, 2018
Actual Primary Completion Date :
Jul 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

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.

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.

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

Outcome Measures

Primary Outcome Measures

  1. Engagement between the 1st minute - 10th minute of each session [through study completion for 8 weeks]

    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.

  2. Engagement between the 25th minute - 35th minute of each session [through study completion for 8 weeks]

    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.

  3. Engagement between the 50th minute - 60th minute of each session [through study completion for 8 weeks]

    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.

  4. Affect between the 1st minute - 10th minute of each session [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.

  5. Affect between the 25th minute - 35th minute of each session [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.

  6. Affect between the 50th minute - 60th minute of each session [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Salvation Army, Hong Kong and Macau Command Hong Kong Hong Kong

Sponsors and Collaborators

  • Food and Health Bureau, Hong Kong
  • The Salvation Army, Hong Kong and Macau Command

Investigators

  • Principal Investigator: Helen Chan, PhD, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Helen YL Chan, Associate Professor, Food and Health Bureau, Hong Kong
ClinicalTrials.gov Identifier:
NCT04352387
Other Study ID Numbers:
  • SA2019
First Posted:
Apr 20, 2020
Last Update Posted:
Apr 20, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Helen YL Chan, Associate Professor, Food and Health Bureau, Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2020