City University of Hong Kong
Kowloon Tong, Hong Kong
NCT Number: NCT07549074
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Kowloon Tong, Hong Kong
Background. Mild cognitive impairment (MCI) is an intermediate stage between cognitively healthy ageing and dementia, with a prevalence rate of 15.6% in older adults worldwide. Older adults with MCI have a higher risk of developing dementia than older people without MCI. Multicomponent interventions that promote a healthy lifestyle to improve cognitive abilities are promising and more favorable than single interventions for older adults with MCI. However, there is a lack of short-term and effective multicomponent interventions.
Objective: This study aims to evaluate the effectiveness of a new short-term multicomponent intervention based on the Integrative Body-Mind-Spiritual Model, an Eastern health care approach that aims to promote the bio-psycho-social-spiritual health of older adults with MCI to improve their cognitive abilities. The multicomponent intervention provides healthy lifestyle psychoeducation and cognitive stimulation, delivered by social workers within 12-weeks. The efficacy and effect sizes of the multicomponent intervention will be compared with those of two single interventions, i.e. healthy lifestyle psychoeducation and cognitive stimulation. The underlying mechanism of change will be investigated.
Hypothesis: (i) the multicomponent intervention leads to significant improvement in cognitive ability, anxiety, depression, healthy lifestyle behavior, and subjective well-being in older adults with MCI at both post-intervention and 3-month follow-up; (ii) the multicomponent intervention leads to larger intervention effects compared to the two single interventions, i.e., cognitive stimulation and lifestyle psychoeducation; and (iii) improvement in cognitive ability is predicted by improvement in healthy lifestyle behavior, depressive and anxiety symptoms.
Research methods: 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. A previous pilot study of the multicomponent intervention yielded positive outcomes, supporting the feasibility of this study.
Significance: This study aims to make a seminal contribution to theoretical advances in the application of Integrative Body-Mind-Spiritual Model in multicomponent interventions to improve the cognitive abilities of older adults with MCI through the promotion of bio-psycho-social-spiritual health, and to investigate its effectiveness and underlying mechanism of change.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The inclusion criteria:
The exclusion criteria:
Those diagnosed with dementia, unable to participate independently in group activities, exhibiting disruptive behavior and/or severely impaired by physical disabilities (e.g. a severe hearing problem) are excluded.
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 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 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 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
Time frame: It will be used before and after the intervention and 3 month follow up (over 26-weeks)
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)
Time frame: It will be used before and after the intervention and 3-month follow up (over 26-weeks)
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)
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)
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)
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).
Contact information is provided by the study sponsor or research team.
City University of Hong Kong
Other
Multicomponent Intervention With Healthy Lifestyle Psychoeducation and Cognitive Stimulation to Improve Cognitive Abilities in Older Adults With Mild Cognitive Impairment-A Double-blind Randomized Control Trial
Acronym: MMI for MCI
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