This study is a feasibility randomized controlled trial (RCT) for an evidence-based intervention for people with moderate to severe dementia in Hong Kong. The psychosocial intervention is adapted from Cognitive Stimulation Therapy (CST), translated and adapted for the Hong Kong Chinese population, and developed within the Medical Research Council (MRC) framework.
The World Health Organization calls for an increase of psychosocial interventions for dementia-a global epidemic. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the National Institute for Health and Care Excellence for improving cognition for mild to moderate dementia. However, there is little guidance on how to maximise cognition for severe dementia. Advanced Cognitive Stimulation Therapy (ACST) will be the first evidence-based complex intervention for moderate to severe dementia developed within the Medical Research Framework and building upon CST's key principles. This feasibility randomised controlled trial (RCT) aims to 1) translate and adapt ACST for the Chinese population; 3) evaluate the feasibility of Advanced Cognitive Stimulation Therapy - Hong Kong (ACST-HK). A sample of 32 participants will be recruited, where 16 will be randomly allocated to ACST, and 16 to treatment as usual (TAU). Data will be collected pre and post the 7-week intervention period. Improving the cognition and QoL for people with moderate to severe dementia is vital because dementia's prevalence is projected to reach 152 million by 2050, resulting in excessive excess disability. Developing an intervention targeting Chinese-the largest aging population-is also novel and allows ACST-HK to impact internationally from its infancy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
A modified version of Cognitive Stimulation Therapy for people with moderate to severe dementia translated and culturally adapted for the Hong Kong Chinese population.
Recruitment (feasibility of ACST-HK)
Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Retention rate (feasibility of ACST-HK)
Retention rate of at least 75% of participants at 8-week follow-up.
Time frame: Descriptive data will be collected during the study and analysed post-intervention; at 8-week follow-up
Negative of adverse events (acceptability of ACST-HK)
Any negative or adverse events related to the intervention
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Intervention fidelity (acceptability of ACST-HK)
Facilitator's completion of the fidelity checklist following each session
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Intervention fidelity (acceptability of ACST-HK)
Video recording of all sessions and an independent researcher rating fidelity with a random 10% of the recordings.
Time frame: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Change in cognitive function
Exploratory primary outcome; measured pre and post intervention with Standardised Mini-Mental State Examination (Molloy \& Standish, 1997) and Test for Severe Impairment (Albert \& Cohen, 1992). SMMSE has 11 questions with scores from 0 to 30, where a low score indicates poor performance. TSI has six domains: motor performance, language comprehension, language production, memory, general knowledge, and conceptualisation. Each domain has a maximum score of 4, and a higher score indicates better cognitive ability.
Time frame: Pre test (baseline: week 0) and post test (week 8)
Change in quality of life
Exploratory primary outcome; measured pre and post test with Quality of Life in Alzheimer's Disease (QoL-AD) (Logsdon et al., 2002). QoL-AD has 13-items, and a sum score range from 13 to 52; higher score denotes better quality of life.
Time frame: Pre test (baseline: week 0) and post test (week 8)
Change in behaviour
Exploratory secondary outcome; measured pre and post test with the Cantonese Version of Neuropsychiatric Inventory (CNPI) (Cummings et al., 1997; Leung et al., 2001). CNPI consists of 12 domains. Each question asks for a frequency of symptoms on a 4-point score, severity on a 3-point score, and distress on a 5-point scale. Higher score denotes higher frequency and severity.
Time frame: Pre test (baseline: week 0) and post test (week 8)
Change in engagement
Exploratory secondary outcome; measured with the Group Observational Measurement of Engagement Tool (Cohen-Mansfield et al., 2017). GOME consists of 5-domains: attendance, engagement, active participation, attitude, and sleep. Each item is measured on a 4- or 7-point Likert scale from 0, none of the time, to 6, all of the time.
Time frame: Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months
Change in overall well-being
Exploratory secondary outcome; measured with the Adapted Greater Cincinnati Chapter Well-Being Observation Tool (Adapted GCCWBOT) (Kinney \& Rentz, 2005). The facilitator or independent researcher will assess 4 participants at a time. Each evaluation will be 62 minutes, and 8 domains will be assessed: interest, attention, pleasure, self-esteem, normalcy, disengagement, sadness, and negative affect.
Time frame: Evaluated by assessor through video recordings for every session; week 1 to until end of study
Change in communication abilities
Exploratory secondary outcome; measured pre and post test with the Holden Communication Scale (Holden \& Woods, 1995). Each item contains is on a 5 point scale, and the questionnaire has a maximum score of 48, where a higher score indicates difficulties in communication.
Time frame: Pre test (baseline: week 0) and post test (week 8)
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