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

Sponsor
City University of Hong Kong
Study ID
NCT07549074
Status
Not Yet Recruiting

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Conditions

  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Apr 23, 2026
Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Multicomponent intervention (HBHG)
    HBHG provides cognitive stimulation and lifestyle psychoeducation, with a total of 28 sessions, two sessions per week (one session of cognitive stimulation and one session of lifestyle psychoeducation), with each session lasting approximately 45 minutes and led by a social worker.
  • Experimental: Cognitive stimulation (CS)
    CS provides 14 sessions of mentally stimulating activities, one session per week, each lasting approximately 45 minutes and led by a social worker
  • Experimental: Lifestyle psychoeducation
    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
  • Sham Comparator: Active Control
    Active control provides both sham cognitive stimulation and sham lifestyle psychoeducation

Primary Outcome Measure

Chinese Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) [ Time Frame: It will be used before and after the intervention and 3 month follow up (over 26-weeks) ]

Central Contacts

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