DementiaNCT04352387
Montessori Based Activities for Dementia
A study testing Montessori Method for Dementia in people with Dementia, run by Food and Health Bureau, Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Montessori Method for Dementia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Aug 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with a diagnosis of dementia at a stage 3 to 5 on the global deterioration scale (GDS)
Who cannot join
- were joining any other dementia training activities
- would highly likely present a hazard to others through disruptive behaviors
- proxy consent could not be obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Montessori Method for Dementia, Usual care
- Keywords
- person-centered, community support
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montessori Method for DementiaBehavioural
The Montessori Method highlights the importance of considering the past experiences, identifying interests and maximizing spared capacity and abilities of each individual.
Usual careBehavioural
Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.
| Study group | Role | What they receive |
|---|---|---|
| Montessori Method for Dementia | Experimental | 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. Receives: Behavioral: Montessori Method for Dementia |
| Usual care | Active comparator | Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion for 8 weeks
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.
Measured: through study completion for 8 weeks
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.
Measured: through study completion for 8 weeks
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.
Measured: through study completion for 8 weeks
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.
Measured: through study completion for 8 weeks
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.
Measured: through study completion for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start24 Aug 2018
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Food and Health Bureau, Hong Kong
- Sponsor type
- Other government
- Collaborators
- The Salvation Army, Hong Kong and Macau Command
- Responsible party
- Principal investigator, Dr. Helen YL Chan, Food and Health Bureau, Hong Kong
- Investigators
- Helen Chan, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352387
- Sponsor's protocol ID
- SA2019
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33413153
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Culturally Adapted Group Based Montessori Based Activities on Engagement and Affect in Chinese Older People With Dementia
- ClinicalTrials.gov ID
- NCT04352387
- Acronym / sponsor ID
- SA2019
- Conditions
- Dementia
- Keywords
- person-centered, community support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Food and Health Bureau, Hong KongOther government
- Collaborators
- The Salvation Army, Hong Kong and Macau Command
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montessori Method for Dementia | Experimental | Behavioral: Montessori Method for DementiaThe 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. |
| Usual care | Active comparator | Behavioral: Usual careActivities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- with a diagnosis of dementia at a stage 3 to 5 on the global deterioration scale (GDS)
Key exclusion criteria (3 listed)
- were joining any other dementia training activities
- would highly likely present a hazard to others through disruptive behaviors
- proxy consent could not be obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montessori Method for DementiaThe Montessori Method highlights the importance of considering the past experiences, identifying interests and maximizing spared capacity and abilities of each individual. | Behavioural | Montessori Method for Dementia |
| Usual careActivities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions. | Behavioural | Usual care |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Derived from this study: PubMed 33413153Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Chan, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montessori Method for Dementia in people with Dementia, run by Food and Health Bureau, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement between the 1st minute - 10th minute of each session (time frame: through study completion for 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04352387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.