Evaluation of Pilot Community-based Multi-domain Program Older Adults at Risk of Cognitive Impairment
Primary Purpose
Cognitive Decline, Cognitive Impairment, Mild
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Multi-domain intervention
Sponsored by

About this trial
This is an interventional prevention trial for Cognitive Decline
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
Sites / Locations
- Geriatric Education And Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention
Wait-list control
Arm Description
Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks. (Week 1 - 24)
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)
Outcomes
Primary Outcome Measures
Change from baseline in cognition at Week 12 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.
Secondary Outcome Measures
Change from baseline in quality of life at Week 12 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.
Change from baseline in aerobic strength at Week 12 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.
Change from baseline in leg strength at Week 12 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
Change from baseline in arm strength at Week 12 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.
Full Information
NCT ID
NCT04440969
First Posted
June 16, 2020
Last Updated
June 18, 2020
Sponsor
Geriatric Education and Research Institute
Collaborators
Ministry of Health, Singapore, Neeuro Pte Ltd, ProAge Pte Ltd, KKT Technology Pte Ltd (Holmusk)
1. Study Identification
Unique Protocol Identification Number
NCT04440969
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
March 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geriatric Education and Research Institute
Collaborators
Ministry of Health, Singapore, Neeuro Pte Ltd, ProAge Pte Ltd, KKT Technology Pte Ltd (Holmusk)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
The effectiveness of the programme on cognitive decline and improvement in fitness and nutrition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Cognitive Impairment, Mild
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention administered is bi-weekly dual-task exercises, small group acitivites and computerised cognitive training for a total of 24 weeks. (Week 1 - 24)
Arm Title
Wait-list control
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Multi-domain intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in cognition at Week 12 and Week 48
Description
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.
Time Frame
Baseline, Week 24 and Week 48
Secondary Outcome Measure Information:
Title
Change from baseline in quality of life at Week 12 and Week 48
Description
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.
Time Frame
Baseline, Week 24 and Week 48
Title
Change from baseline in aerobic strength at Week 12 and Week 48
Description
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.
Time Frame
Baseline, Week 24 and Week 48
Title
Change from baseline in leg strength at Week 12 and Week 48
Description
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
Time Frame
Baseline, Week 24 and Week 48
Title
Change from baseline in arm strength at Week 12 and Week 48
Description
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.
Time Frame
Baseline, Week 24 and Week 48
Other Pre-specified Outcome Measures:
Title
Change from baseline in blood lipid levels at Week 12 and Week 48
Description
Fasting blood sample collected via fingerprick to measure blood lipid levels on a rapid blood kit (Cholesh LDX, Abbott, IL, U.S)
Time Frame
Baseline, Week 24 and Week 48
Title
Evaluation questionnaire
Description
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.
Time Frame
Week 24 and Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiou Liang Wee, PhD
Organizational Affiliation
Geriatric Education and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric Education And Research Institute
City
Singapore
ZIP/Postal Code
768024
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Due to confidentiality issues, individual participant data will not be made public but de-identified data can be obtained upon request.
Citations:
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Evaluation of Pilot Community-based Multi-domain Program Older Adults at Risk of Cognitive Impairment
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