Evaluation of Pilot Community-based Multi-domain Program Older Adults at Risk of Cognitive Impairment

Dementia - Early Detection and Intervention

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 768024
        • Geriatric Education and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks. (Week 1 - 24)

Participants will undergo dual-task physical exercises and small group activities comprising of quizzes, puzzles and simulate daily living activities that have been gamified (Mindfun and MindGym, ProAge,Singapore). They will also play games on a touch screen device (computerised cognitive training) that aims to improve cognition in the domains of attention, memory, spatial ability, decision making and cognitive flexibility (Memorie, Neeuro, Singapore) while wearing the Senzeband, which emits low frequency signals on the forehead picked up by four individual sensors, allowing participant to play certain games without touching the device but by attention and focus (https://www.neeuro.com/senzeband).

Dietary guidance will be delivered via a dietary app (Glycoleap). Participants are expected to take photos of their meals daily and upload them onto the app. Certified dieticians will give advice and tips on their choice of food and how to make healthier choices through the app.

EXPERIMENTAL: Wait-list control
Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks after Intervention Group has completed intervention. (Week 25 - 48)

Participants will undergo dual-task physical exercises and small group activities comprising of quizzes, puzzles and simulate daily living activities that have been gamified (Mindfun and MindGym, ProAge,Singapore). They will also play games on a touch screen device (computerised cognitive training) that aims to improve cognition in the domains of attention, memory, spatial ability, decision making and cognitive flexibility (Memorie, Neeuro, Singapore) while wearing the Senzeband, which emits low frequency signals on the forehead picked up by four individual sensors, allowing participant to play certain games without touching the device but by attention and focus (https://www.neeuro.com/senzeband).

Dietary guidance will be delivered via a dietary app (Glycoleap). Participants are expected to take photos of their meals daily and upload them onto the app. Certified dieticians will give advice and tips on their choice of food and how to make healthier choices through the app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in cognition at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a cognitive test that consists of 12 subtests grouped into five domains - immediate and delayed memory, visuospatial/construction, language and attention. A higher score indicates better cognitive performance.
Baseline, Week 24 and Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in quality of life at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
Quality of Life Questionnaire (EuroQol EQ-5D-5L) index measures participants' perception of their ability to 1) self-care, 2) carry out usual activities, and their levels of 3) mobility, 4) pain/discomfort, and 5) anxiety/depression. The EQ-5D index is derived by combining responses from these 5 categories. A higher index indicates higher quality of life. EQ-5D Visual Analogue Scale (VAS) is a 0 - 100 scale that measures participants' perception of their health status on the day this scale was used, with 100 signifying the best possible state of health.
Baseline, Week 24 and Week 48
Change from baseline in aerobic strength at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
Two-minute step test is a test of aerobic endurance, where participants are required to take as many steps (marching on the spot) as possible in two minutes.
Baseline, Week 24 and Week 48
Change from baseline in leg strength at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
Chair stand is a test of leg strength where participants are required to stand up from seated position as many times as possible in thirty seconds
Baseline, Week 24 and Week 48
Change from baseline in arm strength at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
Handgrip strength is a test of hand and forearm muscular strength, where participants are required to squeeze a dynamometer as hard as possible. Units are measured in kilogrammes.
Baseline, Week 24 and Week 48

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in blood lipid levels at Week 12 and Week 48
Time Frame: Baseline, Week 24 and Week 48
Fasting blood sample collected via fingerprick to measure blood lipid levels on a rapid blood kit (Cholesh LDX, Abbott, IL, U.S)
Baseline, Week 24 and Week 48
Evaluation questionnaire
Time Frame: Week 24 and Week 48

The questionnaire is to address some points of the REAIM framework, which stands for Reach, Effectiveness, Adoption, Implementation and Maintenance.

Questions are either delivered on a 5-point Likert Scale for quantitative analysis (e.g.Did you find the exercises easy to follow? 1 - Extremely difficult, 2 - Quite difficult, 3 - Neutral, 4 - Quite easy, 5 - Extremely easy or as open ended questions for qualitative analysis (e.g. Are there barriers that will prevent you from taking up the programme?) Questionnaires are delivered to participants, centre managers and implementation partners.

Week 24 and Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2018

Primary Completion (ACTUAL)

March 4, 2020

Study Completion (ACTUAL)

March 4, 2020

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (ACTUAL)

June 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • GERI1613
  • MOH/NIC/COG02/2017 (OTHER_GRANT: MOH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to confidentiality issues, individual participant data will not be made public but de-identified data can be obtained upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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