Trial Outcomes & Findings for Play Intervention for Dementia for Promoting Cognitive Function: A Feasibility Study (NCT NCT02846415)
NCT ID: NCT02846415
Last Updated: 2023-10-23
Results Overview
The Hong Kong version of the 11-item Montreal Cognitive Assessment scale was used to measure the global cognitive functions of the participants. The scores range from 0 to 30, and lower scores refer to lower levels of cognitive function. The scores reported are the adjusted post-test mean scores using its baseline measures as a covariate in ANCOVA.
COMPLETED
NA
30 participants
At Baseline, after 2 months (T1)
2023-10-23
Participant Flow
Participant milestones
| Measure |
PID Group
Experimental group receiving the Play Intervention for Dementia
Play Intervention for Dementia: 1. 8 weekly session, 45-75 minutes each 2. Play with toys 3. Sessions will be facilitated by a play specialist, trained play assistants, and centre staff.
|
Wait-list Control Group
Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
12
|
|
Overall Study
COMPLETED
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
PID Group
Experimental group receiving the Play Intervention for Dementia
Play Intervention for Dementia: 1. 8 weekly session, 45-75 minutes each 2. Play with toys 3. Sessions will be facilitated by a play specialist, trained play assistants, and centre staff.
|
Wait-list Control Group
Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PID Group
n=18 Participants
Experimental group receiving the Play Intervention for Dementia
Play Intervention for Dementia:
1. 8 weekly sessions, 45-75 minutes each
2. Play with toys
3. Sessions will be facilitated by a play specialist, trained play assistants, and center staff.
|
Wait-list Control Group
n=12 Participants
Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81.1 years
STANDARD_DEVIATION 7.41 • n=18 Participants
|
85.3 years
STANDARD_DEVIATION 6.56 • n=12 Participants
|
83.2 years
STANDARD_DEVIATION 7.18 • n=30 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=18 Participants
|
9 Participants
n=12 Participants
|
22 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=18 Participants
|
3 Participants
n=12 Participants
|
8 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Hong Kong
|
18 participants
n=18 Participants
|
12 participants
n=12 Participants
|
30 participants
n=30 Participants
|
|
Marital status
Married
|
7 Participants
n=18 Participants
|
5 Participants
n=12 Participants
|
12 Participants
n=30 Participants
|
|
Marital status
Single/Divorced/Widowed
|
11 Participants
n=18 Participants
|
7 Participants
n=12 Participants
|
18 Participants
n=30 Participants
|
|
Educational level
No formal schooling/primary
|
12 Participants
n=18 Participants
|
10 Participants
n=12 Participants
|
22 Participants
n=30 Participants
|
|
Educational level
Secondary/tertiary
|
6 Participants
n=18 Participants
|
2 Participants
n=12 Participants
|
8 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: At Baseline, after 2 months (T1)The Hong Kong version of the 11-item Montreal Cognitive Assessment scale was used to measure the global cognitive functions of the participants. The scores range from 0 to 30, and lower scores refer to lower levels of cognitive function. The scores reported are the adjusted post-test mean scores using its baseline measures as a covariate in ANCOVA.
Outcome measures
| Measure |
PID Group
n=18 Participants
Experimental group receiving the Play Intervention for Dementia
Play Intervention for Dementia: 1. 8 weekly session, 45-75 minutes each 2. Play with toys 3. Sessions will be facilitated by a play specialist, trained play assistants, and centre staff.
|
Wait-list Control Group
n=12 Participants
Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.
|
|---|---|---|
|
Adjusted Post-test Score of Montreal Cognitive Assessment Scale After 2 Months of Intervention
|
8.84 score on a scale
Interval 7.51 to 10.17
|
7.40 score on a scale
Interval 5.75 to 9.06
|
SECONDARY outcome
Timeframe: At Baseline, after 2 months (T1)The 10-item Fuld Object Memory Evaluation was used to measure memory of participants. The total storage (score range: 0 to 50) was reported. Higher scores refer to better memory. The scores reported are the adjusted post-test mean scores using its baseline measures as a covariate in ANCOVA.
Outcome measures
| Measure |
PID Group
n=18 Participants
Experimental group receiving the Play Intervention for Dementia
Play Intervention for Dementia: 1. 8 weekly session, 45-75 minutes each 2. Play with toys 3. Sessions will be facilitated by a play specialist, trained play assistants, and centre staff.
|
Wait-list Control Group
n=12 Participants
Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.
|
|---|---|---|
|
Adjusted Post-test Score of Fuld Object Memory Evaluation - Total Storage Score
|
18.92 score on a scale
Interval 16.38 to 21.45
|
13.00 score on a scale
Interval 9.93 to 16.16
|
SECONDARY outcome
Timeframe: At Baseline, after 2 months (T1)The Modified Fuld Verbal Fluency test was used to assess verbal fluency by asking participants to name animals, fruits and vegetables in 1 minute or 30 seconds. The scores were the sum of the items being recalled, and higher total scores refer to better verbal fluency. The scores reported are the adjusted post-test mean scores using its baseline measures as a covariate in ANCOVA.
Outcome measures
| Measure |
PID Group
n=18 Participants
Experimental group receiving the Play Intervention for Dementia
Play Intervention for Dementia: 1. 8 weekly session, 45-75 minutes each 2. Play with toys 3. Sessions will be facilitated by a play specialist, trained play assistants, and centre staff.
|
Wait-list Control Group
n=12 Participants
Participants will receive usual care offered by the day care centre, including health and social services, and meals, etc.
|
|---|---|---|
|
Adjusted Post-test Score of the Modified Verbal Fluency Test
|
14.34 score on a scale
Interval 12.54 to 16.13
|
13.16 score on a scale
Interval 10.95 to 15.38
|
Adverse Events
PID Group
Wait-list Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Daphne Cheung
School of Nursing, The Hong Kong Polytechnic University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place