Clinical trial NCT04615169: Multi-component Cognitive Intervention for Older Adults With Mixed Cognitive Abilities
Official title: Multi-component Cognitive Intervention for Older Adults With Mixed Cognitive Abilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Training
Dementia
Occupational Therapy
Aging
Long Term Care
Keywords: cognitive training
dementia prevention
Dementia
occupational therapy
community based practice
older people
long term care
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A multi-center one-group pretest, post-test, and 3-month follow up design
Primary purpose: TREATMENT

Brief summary: Objective: To assess the feasibility and preliminary effectiveness of an evidence-driven, pragmatic multi-component cognitive intervention with simulated everyday tasks (MCI-SET) with an inclusive group design in community centers Methods: One group, pre-test, post-test, and 3-month follow up research design. The participants who were \>=65 and frail, dependence in \>= one activity of daily living, or with a confirmed dementia from eight community centers. MCI-SET consisted 12 two-hour weekly group sessions. Feasibility was described with intervention development, fidelity, and acceptability. Outcomes included general daily functioning, general cognition, memory, attention, executive functioning, and processing speed.

Detailed description: According to the World Alzheimer Report 2018, 50 million people are living with dementia and the number is expected to triple to 152 million by 2050. Most people at high risk of dementia or with dementia reside in the community. Effective community-based programs can help to maintain functional levels and mitigate or prevent excessive functional decline. There are increasing empirical evidence to support structured and regular cognitive activities as part of brain health lifestyle .

Cognitive intervention is an increasing popular approach that aim to maintain or improve the cognitive functioning of the older adults with or without cognitive impairments. Appropriate cognitive intervention has the potential to change their brain neuro-mechanism. Recent evidence suggests that repeated practices of a carefully designed cognitive exercises with a high degree of similarity with real-life activities of daily living (ADL) (e.g., remembering the instructions for taking prescription medicine, identifying the medicine precautions, etc.) can improve both cognitive skills and cognitive functional performance.

Because of the complexity of cognitive issues people with cognitive impairments encounter, scholars have advocated for a multi-component cognitive intervention that includes more than one approach to make the best use of the individual approaches. The investigators conducted a quasi-experimental study that combined motor-cognitive dual-task exercises with high cognitive demands, cognitive training, and cognitive rehabilitation. The results showed that the intervention can improve cognitive skills and cognitive functional performance for people with mild cognitive impairments.

However, the need to strengthen the research design and to standardize treatment protocols led most cognitive intervention research to target a group of participants with similar cognitive skills, such as those with normal cognition, those with mild cognitive impairments, or those with dementia, etc. This homogeneity in participants is in sharp contrast to what is observed in communities, where most likely the group is inclusive of persons with different levels of cognitive skills. The efficacy of cognitive intervention with an inclusive group design was rarely examined.

Scholars have called for more effort to speed up the process of bridging evidence-based intervention to the everyday settings people live in. Cognitive intervention is in a situation of "leaky pipeline," that is, no systematic examination of how the evidence can be translated, tested in real-world settings (practice), and/or implemented across communities in the continuum of research evidence to widespread implementation. The increasing use of feasibility research design is mostly used as a precursor of randomized clinical trial, examining whether a study protocol requires adjustment, what the barriers and potential strategies are. With the abundance of research that supports the efficacy of cognitive intervention, to the best of the investigators' knowledge, there are no study that investigated the transportability of evidence-based cognitive intervention into the community.

This study discusses the feasibility, implementation, and preliminary effectiveness of an evidence-driven, multi-component cognitive intervention using simulated everyday tasks (MCI-SET) for cognitively-vulnerable older adults in community organizations in two cities in southern Taiwan.

Eligibility criteria: Inclusion Criteria:

equal to or more than 65 years old, and frailty status according to the Study of Osteoporotic Fractures (SOF) criteria of frailty, or dependence with at least one daily activities.

Exclusion Criteria:

People with non-cognitive issues, such as severe visual, hearing, or physical impairments, that interfered with completion of evaluations.

Primary outcomes:
measure: Kihon Checklist-Taiwan (KCL)
timeFrame: up to one month before the start of intervention
measure: Kihon Checklist-Taiwan (KCL)
timeFrame: up to one month after the end of intervention
measure: Kihon Checklist-Taiwan (KCL)
timeFrame: up to 4 months after the end of intervention
measure: General Cognition
timeFrame: up to one month before the start of intervention
measure: General Cognition
timeFrame: up to one month after the end of intervention
measure: General Cognition
timeFrame: up to 4 months after the end of intervention
Secondary outcomes:
measure: Functional episodic memory
timeFrame: up to one month before the start of intervention
measure: Functional episodic memory
timeFrame: up to one month after the end of intervention
measure: Functional episodic memory
timeFrame: up to 4 months after the end of intervention
measure: short-term memory and working memory
timeFrame: up to one month before the start of intervention
measure: short-term memory and working memory
timeFrame: up to one month after the end of intervention
measure: short-term memory and working memory
timeFrame: up to 4 months after the end of intervention
measure: Attention and executive Functioning
timeFrame: up to one month before the start of intervention
measure: Attention and executive Functioning
timeFrame: up to one month after the end of intervention
measure: Attention and executive Functioning
timeFrame: up to 4 months after the end of intervention
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University
Study officials:
affiliation: National Cheng Kung University
name: Ling-Hui Chang, Ph.D
role: STUDY_CHAIR
References:
citation: Mao HF, Tsai AY, Chang LH, Tsai IL. Multi-component cognitive intervention for older adults with mixed cognitive levels: implementation and preliminary effectiveness in real-world settings. BMC Geriatr. 2021 Oct 12;21(1):543. doi: 10.1186/s12877-021-02489-z.