Clinical trial NCT04440969: Evaluation of Pilot Community-based Multi-domain Program Older Adults at Risk of Cognitive Impairment
Official title: Dementia - Early Detection and Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Cognitive Impairment, Mild
Lead sponsor: Geriatric Education and Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Singapore
name: Neeuro Pte Ltd
name: ProAge Pte Ltd
name: KKT Technology Pte Ltd (Holmusk)
First posted: 2020-06-22
Enrollment: 199
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The multi-domain programme was adapted from a larger international multi-domain interventional study for the Singapore community of older adults at risk of cognitive impairment. This programme comprises nutritional, physical and cognitive components delivered by implementation partners in the community. A dementia risk screening tool developed from the Singapore Longitudinal Ageing Study (SLAS) data was used to screen potential participants. The nutritional component includes nutrition guidance via a nutritional app, while cognition component involves computerised training on a touch screen device and physical aspects involves dual-task exercises.

Detailed description: Older people like to continue to think clearly, remember accurately, and make good decisions. The loss of the ability to live independently is one of the greatest fears adults express when considering old age. As physical fitness declines, the brain also ages. While cognition in areas related to wisdom and experience improve in older adults, others like memory, attention, and reaction time can decline and affect daily life. As life expectancy increases, maintaining cognition is critical to productive and healthy aging. Older adults want to continue to negotiate the environment, perform routine tasks (e.g. driving), learn new things, and live independently. Cognitive impairment creates significant challenges for individuals, their families and friends, and clinicians who provide their health care. Furthermore, available research indicates that cognitive impairment is not detected in substantial proportions of older people in primary care who have the condition. Early detection allows for earlier diagnosis and appropriate intervention, education, psycho-social support, and engagement in shared decision-making regarding life planning, financial matters, and health care. Based on this, there is a need for scalable, implementable intervention programmes which can be introduced in the community.

Previous studies have corroborated the efficacy of certain aspects of training which can promote delay in cognitive decline. Specifically, these encompass nutritional, cognitive and physical activity. Individually, these components have been extensively validated and proven effective in negating cognitive decline. However, little attempts have been made to evaluate the effectiveness and feasibility of combining these components into a multi-modal program. The only preceding study to have proven efficacy of multi-modal programs in improving cognition was carried out in the FINGER trial. However, to date, no similar studies have been carried out locally. Therefore, this study aims to address these questions; by using a mixed method approach; combining both qualitative and quantitative methods to assess the achievability of such a programme.

The programme aims to identify individuals at risk of cognitive decline and is offered to ensure intervention measures are adopted at early stages. The multi-domain program comprises a combination of nutritional guidance, group physical activity and cognitive training segments; all of which are individually regarded as proven interventions for cognitive impairment. The program will be coordinated between three commercial entities, Holmusk, Neeuro and ProAge and is funded by the National Innovation Challenge (NIC), MOH, Singapore. As part of the programme, the investigators will be utilizing a locally developed risk score created from the Singapore Longitudinal Aging study (SLAS), that can be widely administered and is applicable to the local population. Therefore, the study aims to use a mixed methods approach to evaluate:

1. The feasibility and sustainability of implementing the programme, which will be assessed based on several considerations such as reach, implementation and maintenance or areas of improvement.
2. The effectiveness of the programme on cognitive decline and improvement in fitness and nutrition.

Eligibility criteria: Inclusion Criteria:

* Above 55 years of age
* Interested \& willing to participate in a lifestyle \& cognition training programme
* Residing in Singapore over the next 1 year
* Have a risk score of more than 6-8, implying a 10-20% risk of developing cognitive decline over the next 5 years

Exclusion Criteria:

* Diagnosed with cognitive disorders such as mild cognitive impairment, dementia or Parkinson's Disease
* Wheelchair bound
* Total hearing or visual impairment
* Medical instructions prohibiting participation in the programme

Primary outcomes:
measure: Change from baseline in cognition at Week 12 and Week 48
timeFrame: Baseline, Week 24 and Week 48
Secondary outcomes:
measure: Change from baseline in quality of life at Week 12 and Week 48
timeFrame: Baseline, Week 24 and Week 48
measure: Change from baseline in aerobic strength at Week 12 and Week 48
timeFrame: Baseline, Week 24 and Week 48
measure: Change from baseline in leg strength at Week 12 and Week 48
timeFrame: Baseline, Week 24 and Week 48
measure: Change from baseline in arm strength at Week 12 and Week 48
timeFrame: Baseline, Week 24 and Week 48
Other outcomes:
measure: Change from baseline in blood lipid levels at Week 12 and Week 48
timeFrame: Baseline, Week 24 and Week 48
measure: Evaluation questionnaire
timeFrame: Week 24 and Week 48
Locations:
city: Singapore
country: Singapore
facility: Geriatric Education And Research Institute
Study officials:
affiliation: Geriatric Education and Research Institute
name: Shiou Liang Wee, PhD
role: PRINCIPAL_INVESTIGATOR
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