Play Intervention for Dementia for Promoting Cognitive Function
Phase: NA
Conditions: Dementia, Alzheimer Disease
Sponsor: The Hong Kong Polytechnic University

 
1 
 
Study Protocol and Statistical Analysis Plan 
 
Full Title of the Study 
Cognitive Stimulating Play Intervention for Dementia: A Feasibility Randomized Controlled 
Trial 
 
Study Investigator(s) 
Principle Investigator 
Name 
Daphne Sze Ki Cheung  
Position 
Assistant Professor 
Unit/ Department 
School of Nursing 
Organization 
The Hong Kong Polytechnic University   
Phone 
(852) 2766 4534 
Email 
daphne.cheung@polyu.edu.hk 
 
Sub-investigators 
Name 
A. Ka Tat Tsang 
Position 
Professor 
Unit/ Department 
Factor-Inwentash Faculty of Social Work 
Organization 
University of Toronto, Toronto, Ontario, Canada 
 
Name 
Daniel Wing Leung Lai 
Position 
Professor 
Unit/ Department 
Department of Applied Social Sciences 
Organization 
The Hong Kong Polytechnic University, Hong Kong, China 
 
Name 
Angela Yee Man Leung 
Position 
Associate Professor 
Unit/ Department 
School of Nursing 
Organization 
The Hong Kong Polytechnic University   
 
 

 
2 
Introduction 
Around 47 million people worldwide are affected by dementia, and the number is projected 
to triple in 2050.1 Treatment that reverse the pathological changes in the brain is not available 
currently, but cognition of People with Dementia (PWD) could be improved through 
intervention. Among the three major approaches in cognitive intervention for PWD, namely 
cognitive training, cognitive rehabilitation, and cognitive stimulations,2 cognitive stimulation 
was the one that recommended for enhancing the cognitive functions of PWD by the UK’s 
National Institute for Health and Clinical Excellence.3 Therefore, this study will apply an 
adapted intervention targeting on stimulating cognitive function of PWD—the Cognitive 
Stimulating Play Intervention (CoS-Play)—that involves the six mind-body functional 
domains advocated for enhancing cognition of PWD by Wong and colleagues in 2014.4 They 
include auditory music and rhythm, visuospatial and fine motor skills, language and verbal 
skills, executive functions, kinesthetic and gross motor skills, and social functioning. The 
CoS-Play Intervention will address the shortcoming of the heavy reliance on language of 
conventional cognitive stimulation programs, and focus on the application of play. Some 
evidence from the literature demonstrated that playing games is beneficial to PWD’s self-
confidence, social engagement with other participants, cognition and behavioural symptoms, 
but the methodological quality of some studies were found to be generally inadequate and not 
anchored in a conceptual framework.5-6 This study will address theses knowledge gaps using 
a randomized controlled trial and employing both quantitative measures and qualitative 
interviews to evaluate the feasibility and preliminary efficacy of the intervention. 
 
Objectives of the Study 
By carrying out the intervention in local day-care centers in Hong Kong alongside a wait-list 
control group, the study aimed at exploring the feasibility of the Cognitive Stimulating Play 
Intervention (CoS-Play) as a means of cognitive stimulation for people with early to 
moderate dementia, and examining its preliminary effects on the cognitive functions.  
 
Study Design and Procedures 
Design 
This is a randomized controlled trial employing quantitative pre-intervention and post-
intervention assessment of participants, as well as qualitative interviews with staff members 
of 2 community day-care centers to evaluate the feasibility and preliminary efficacy of the 

 
3 
intervention. This design allows us to reflect on the utility of the intervention in real practice, 
which is particularly important during the developmental stage of a complex intervention.7 
 
Population 
Eligible participants will be community dwelling adults aged 60 or above with a medically 
confirmed diagnosis of any type of dementia (such as Alzheimer disease, vascular dementia, 
etc). Those who will be included as participants are people at the stage of early to moderate 
dementia (stages 4-6 according to the Global Deterioration Scale8), able to sit independently, 
and physically stable. Those with acute physical or mental illnesses will be excluded. Center 
staffs who will be assisting in the CoS-Play will be invited to take part in interviews so that 
their opinions on the implementation of the program could be solicited  
 
Procedures 
Assessment of center eligibility (N=2 centers) 
¯ 
 Assessment of participant eligibility  
and exclusion of participants who do not meet inclusion criteria 
¯ 
Baseline assessment (T0) 
¯ 
Randomization of the centers (N=2 centers) 
¯ 
¯ 
Intervention group (n=1 center) 
Control group (n=1 center) 
¯ 
¯ 
Eight weekly group-based intervention 
Eight weekly group-based social activities 
¯ 
¯ 
Follow-up and Outcome Measurement 
• Immediate post-intervention 
assessment (T1) 
• Individual interviews with 2 center 
staffs who have joined the program 
• Immediate post-intervention 
assessment (T1) 

 
4 
Study Outcomes 
Quantitative outcomes 
A trained research assistant who will be blinded to the group allocation will assess the 
cognitive functions of the participants using the Montreal Cognitive Assessment (MoCA), the 
Fuld Object Memory Evaluation (FOME), and the Modified Verbal Fluency test (embedded 
in the FOME), at baseline (T0), and immediately postintervention (T1).  
a. Montreal Cognitive Assessment (MoCA). The Hong Kong version of the MoCA will 
be used to measure the global cognitive functions of the participants.9 This instrument 
has high internal consistency (Cronbach a a = .767), excellent inter-rater reliability 
(Intra-class Correlation Coefficient [ICC] = 0.987), and good construct validity as 
compared with the Mini Mental State Examination and Global Deterioration Scale.9 It 
consists of 11 items, and lower total scores refer to lower levels of cognitive function.  
b. Fuld Object Memory Evaluation (FOME). Participants’ memory will be evaluated 
using the FOME.10 The participants will be asked to memorise and recall 10 items 
across 5 recall trials and a delayed recall trial. The instrument has been validated in 
the Hong Kong Chinese population and found to have better construct validity than 
the Mini Mental State Examination (r = 0.69-0.74), and to have test–retest reliability 
(ICC = 0.91-0.96).11 Three FOME scores, namely total storage (possible range of 0-
50), total retrieval (possible range of 0-50), and delayed recall (0-10) will be derived. 
Total storage represents the encoding function, while total retrieval and delayed recall 
refer to the retrieval function. Higher scores represent better memory.  
c. Modified fluid verbal fluency test. Verbal fluency will be assessed using the 
Modified Fuld Verbal Fluency test,12 which was modified from the original Fuld 
Verbal Fluency test embedded in the FOME as a distraction task. Participants will be 
asked to name animals, fruits, and vegetables in 1 minute or 30 seconds. The 
construct validity was acceptable as compared with the Mini Mental State 
Examination (r = 0.76), and the test had good test–retest reliability (r = 0.74).12 Total 
scores are the sum of the items being recalled, with higher total scores referring to 
better verbal fluency.  
 

 
5 
Qualitative outcomes 
The staff will be interviewed about their perceptions of: (a) the acceptability of the program, 
(b) the feasibility of integrating the program to the usual service operations of the center, (c) 
the practicality of the program, and (d) the effects of the program on participants.  
The guiding questions will be as follows:  
a. Acceptability. 
What do you think about the acceptability or satisfaction of the intervention to people 
with moderate dementia?  
b. Integration. 
What would you think if the intervention were to be integrated into the normal routine 
of your center?  
c. Practicality.  
What are the practical concerns regarding the CoS-Play?  
d. Efficacy. 
What changes did you observe in the participants after they had participated in the 
CoS-Play?  
Statistical Analysis Plan 
Quantitative analysis 
SPSS Statistics 23 will be used for all analyses. Data collection and entry will be conducted 
by a research assistant who will be blinded to the group allocations. The demographic data 
and the participants’ performance at baseline will be compared with Fisher exact test for 
categorical data, and with the Mann-Whitney U test for continuous data to detect differences 
between intervention and control groups. Intention-to-treat methods will be used for all 
analyses. Missing values will be imputed with the last observation carried forward approach. 
Analysis of covariance (ANCOVA) will be used to examine whether there are significant 
differences between groups on the outcome measures after 8 weeks of the intervention, using 
its baseline measures as a covariate. A 2-sided significance test (P < .05) will be applied. The 
magnitude of the effects between the intervention and control groups will be displayed as a 
partial h2 effect size.13 

 
6 
Qualitative analysis 
A deductive content analysis approach will be used to analyze the transcribed interview 
verbatim in relation to the feasibility of the intervention, which is considered suitable for a 
detailed analysis of the 4 indicators of the feasibility of the intervention—acceptability, 
integration, practicality, and effects.14 The principle investigator and a trained research 
assistant will first immerse themselves in the data, decide on the analysis of manifest content 
together before coding the transcripts individually. After that, both of them will discuss 
discrepancies in the coding and will reach a consensus on the categories that will be 
generated. 
 
 

 
7 
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