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Completed

NCT Number: NCT04352387

Montessori Based Activities for 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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Salvation Army, Hong Kong and Macau Command

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montessori Method for Dementia

Behavioral

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

Usual Care

Behavioral

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

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Food and Health Bureau, Hong Kong

Other Gov

Collaborators

  • The Salvation Army, Hong Kong and Macau Command

Registry information

Official study title

Effects of a Culturally Adapted Group Based Montessori Based Activities on Engagement and Affect in Chinese Older People With Dementia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2020
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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