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

Cognitive Decline Clinical Trial

Official title:

Dementia - Early Detection and Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440969
• Other study ID #: GERI1613
• Secondary ID: MOH/NIC/COG02/20
• Status: Completed
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: March 4, 2020

Study information

• Verified date: June 2020
• Source: Geriatric Education and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment, Mild

Intervention

Behavioral:
• Multi-domain intervention
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.

Locations

Country	Name	City	State
Singapore	Geriatric Education And Research Institute	Singapore

Sponsors (5)

Lead Sponsor	Collaborator
Geriatric Education and Research Institute	KKT Technology Pte Ltd (Holmusk), Ministry of Health, Singapore, Neeuro Pte Ltd, ProAge Pte Ltd

Country where clinical trial is conducted

Singapore, 

References & Publications (7)

Ahlskog JE, Geda YE, Graff-Radford NR, Petersen RC. Physical exercise as a preventive or disease-modifying treatment of dementia and brain aging. Mayo Clin Proc. 2011 Sep;86(9):876-84. doi: 10.4065/mcp.2011.0252. Review. — View Citation

Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Bäckman L, Hänninen T, Jula A, Laatikainen T, Lindström J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17. — View Citation

Lustig C, Shah P, Seidler R, Reuter-Lorenz PA. Aging, training, and the brain: a review and future directions. Neuropsychol Rev. 2009 Dec;19(4):504-22. doi: 10.1007/s11065-009-9119-9. Epub 2009 Oct 30. Review. — View Citation

Morley JE, Morris JC, Berg-Weger M, Borson S, Carpenter BD, Del Campo N, Dubois B, Fargo K, Fitten LJ, Flaherty JH, Ganguli M, Grossberg GT, Malmstrom TK, Petersen RD, Rodriguez C, Saykin AJ, Scheltens P, Tangalos EG, Verghese J, Wilcock G, Winblad B, Woo J, Vellas B. Brain health: the importance of recognizing cognitive impairment: an IAGG consensus conference. J Am Med Dir Assoc. 2015 Sep 1;16(9):731-9. doi: 10.1016/j.jamda.2015.06.017. — View Citation

Ngandu T, Lehtisalo J, Solomon A, Levälahti E, Ahtiluoto S, Antikainen R, Bäckman L, Hänninen T, Jula A, Laatikainen T, Lindström J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12. — View Citation

Rawtaer I, Feng L, Yuen VH, Li J, Chong MS, Lim WS, Lee TS, Qiu C, Feng L, Kua EH, Ng TP. A Risk Score for the Prediction of Neurocognitive Disorders among Community-Dwelling Chinese Older Adults. Dement Geriatr Cogn Disord. 2016;41(5-6):348-58. doi: 10.1159/000447448. Epub 2016 Jul 20. — View Citation

Smith PJ, Blumenthal JA. Diet and neurocognition: review of evidence and methodological considerations. Curr Aging Sci. 2010 Feb;3(1):57-66. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in blood lipid levels at Week 12 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
Other	Evaluation questionnaire	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
Primary	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.	Baseline, Week 24 and Week 48
Secondary	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.	Baseline, Week 24 and Week 48
Secondary	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.	Baseline, Week 24 and Week 48
Secondary	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	Baseline, Week 24 and Week 48
Secondary	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.	Baseline, Week 24 and Week 48