Multicomponent Intervention to Improve Cognitive Abilities in Older Adults With Mild Cognitive Impairment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorCity University of Hong Kong

About this trial

The research aims to investigate the effectiveness of a new short-term multicomponent intervention to promote the bio-psycho-social-spiritual health of older adults with MCI to improve their cognitive abilities.

In this study, the multicomponent intervention consists of healthy lifestyle psychoeducation and cognitive stimulation. This study is a double-blind, clustered, randomized, controlled, four-arm parallel group study. 200 eligible older adults with MCI are openly recruited into activity groups in local elderly centres. The activity groups are randomly allocated to three intervention groups (i.e., multicomponent intervention, cognitive stimulation and lifestyle psychoeducation) and a control group in a 1:1:1:1 ratio. The participants with MCI are blinded on group allocation and kept uninformed which type of intervention they are receiving. An investigator, blinded to group allocation and intervention, assess outcomes using standardized assessment tools before and after the intervention and after 3 months.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age 60 years or older;

diagnosis of MCI or mild neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorder (Fifth edition, Text Revision) (American Psychiatric Association, 2022); Participants who are not diagnosed with MCI will undergo a screening assessment by a research assistant using both the Montreal Cognitive Assessment (MoCA) (Chinese version) with a total score of 19 to 21 represents MCI. (Yeung et al., 2014);

awareness of memory loss with memory complaints;

member of collaborating elderly centre;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive stimulation

    Behavioral

    Cognitive stimulation provides 14 sessions of mentally stimulating activities, one session per week, each lasting approximately 45 minutes and led by a social worker/counsellor

  • Lifestyle psychoeducation

    Behavioral

    Lifestyle psychoeducation provides 14 psychoeducation sessions on healthy lifestyles, one session per week, each session lasts about 45 minutes and is led by a social worker/counsellor

  • Sham cognitive stimulation

    Behavioral

    Sham cognitive stimulation provides 14 sessions of searching website information on local leisure and recreational activities, followed by a quiz. One session per week, each session lasting approximately 45 minutes and led by a social worker/counsellor

  • Sham Lifestyle Psychoeducation

    Behavioral

    Sham Lifestyle Psychoeducation provides 14 sessions of reading standardized educational material on MCI provided by the government (available at https://www.healthyhkec.org/ healthcare/eldercare/newhabit/), followed by a quiz. One session per week, each session lasting approximately 45 minutes and led by a social worker/counsellor

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Multicomponent intervention (HBHG)Experimental treatment 2 interventions
Group B: Cognitive stimulation (CS)Experimental treatment 2 interventions
Group C: Lifestyle psychoeducationExperimental treatment 2 interventions
Group D: Active ControlSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Chinese Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

The ADAS-Cog has good validity and internal consistency (Cronbach's α = 0.9; Chu et al., 2000), and covers eleven cognitive tasks, including word recall (e.g. a list of 10 words is read by the subject, and then the subject is asked to verbally recall as many of the words as possible), naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition, language, comprehension of spoken language, and word finding difficulty

Time frame
It will be used before and after the intervention and 3 month follow up (over 26-weeks)
2

Chinese Montreal Cognitive Assessment (MoCA)

• The MoCA has satisfactory validity, internal consistency (Cronbach's α = 0.8; Yeung et al., 2014), and is widely used for screening and assessment of MCI (Chen et al, 2021). It assesses global and specific cognitive abilities, including memory recall (e.g., I read some words to you earlier, which I asked you to remember. Tell me as many of those words as you can remember), attention, concentration, executive functions, language, visuospatial skills, abstract reasoning, calculation and orientation (Yeung et al., 2014).

Time frame
It will be used before and after the intervention and 3-month follow up (over 26-weeks)

Secondary outcomes

1

Chinese Geriatric Anxiety Inventory (GAI)

GAI is a 20-item scale for assessing self-reported anxiety symptoms in older adults with MCI with good validity and internal consistency (Cronbach's α = 0.9; Yan et al., 2014). Each item (e.g., I find it hard to relax) is answered with a dichotomous response of agree or disagree. A cut-off GAI score of ≥ 11 indicates clinical anxiety (Yan et al., 2014), which is adopted in this study

Time frame
It will be used before and after the intervention and 3-month follow up (over 26-weeks)
2

Chinese Geriatric Depression Scale (GDS)

GDS is a 15-item scale for assessing self-reported depressive symptoms in older adults with MCI with satisfactory validity, internal consistency (Cronbach's α = 0.9; Chiu et al., 1994b). Each item (e.g., Do you often get bored?) is answered with a dichotomous response of yes or no. A cut-off GDS score of ≥ 8 indicates clinical depression (Chiu et al., 1994b), which is adopted in this study

Time frame
It will be used before and after the intervention and 3-month follow up (over 26-weeks)
3

Chinese Health-Promoting Lifestyle Profile-Short form (HPLP-SF)

HPLP-SF is a 30-item scale for assessing self-reported healthy lifestyle behavior in six dimensions, including: self-actualization, health responsibility, exercise, nutrition, interpersonal support and stress management, with satisfactory reliability and validity (Cronbach's α = 0.90; Teng et al, 2010). Each item (e.g., engaging in a supervised exercise class or activity) is rated on a 5-point Likert-type scale ranging from 1 (never) to 4 (always).

Time frame
It will be used before and after the intervention and 3-month follow up (over 26-weeks)
4

Chinese WHO 5-item Well-Being Index (WHO-5)

WHO-5 is a 5-item scale for assessing subjective wellbeing with satisfactory validity and internal consistency (Cronbach's α = 0.85; Fung et al., 2022). Each item (e.g., feel a sense of companionship in life) is rated on a 5-point Likert-type scale ranging from 1 (very dissatisfied) to 5 (very satisfied).

Time frame
It will be used before and after the intervention and 3-month follow up (over 26-weeks)

Other outcomes

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