Filipino Multicomponent Intervention to Maintain Cognitive Performance in High-Risk Population (FINOMAIN): Study Protocol for a Cluster Randomized Controlled Trial

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  • Jacqueline Dominguez
  • Ma Fe de Guzman
  • S. H.Annabel Chen
  • Mary Sano
  • Waldemar, Gunhild
  • Thien Kieu Thi Phung

Background: More than half of the people with dementia live in lower-middle income countries (LMIC), yet we lack research and evidence-based knowledge to guide health promotion and prevention strategies for cognitive decline. In the Philippines, the prevalence of mild cognitive impairment (MCI) and cardiovascular risk factors among older persons are high, making this population at high risk for developing dementia. This protocol describes a cluster randomized controlled trial that aims to investigate the efficacy of a multicomponent intervention to maintain cognitive performance among high-risk population. Methods: This is a cluster-randomized, two-arm, single-blind trial of a multicomponent intervention that combines dance called INDAK (Improving Neurocognition through Dance and Kinesthetics), nutrition counseling, and vascular risk management. The intervention arm will receive 12 months (1-h, twice per week) of INDAK and every 3 months of nutrition counseling and intensive vascular risk management and monitoring. The control group will receive the usual vascular care advice and referral. A total of 605 (20–25 clusters per arm) community-dwelling Filipino older adults aged ≥ 60 years old with MCI will participate in the study and will be assessed at baseline, 6th- and 12th-month follow-up. The primary outcome is cognitive performance assessed by the Alzheimer's Disease Assessment Scale—Cognitive (ADAS-Cog), Mnemonic Similarity Tasks (MST), and executive function composite (EFC). Secondary outcomes are functional connectivity assessed through brain imaging, and measures of behavioral, functional level, and quality of life. Discussion: The study aims to provide scientific evidence on a public health intervention that is contextualized in a community setting to reduce dementia risk among older adults with MCI. This model can be an ecological, low-cost, and effective program, thereby conducive to widespread implementation in the Philippines as well as in other low-resource settings with similar public health challenges. The pilot phase was underway with eight villages (clusters), but temporarily interrupted by the pandemic. The full study is anticipated to start after community restrictions are eased.

OriginalsprogEngelsk
Artikelnummer685721
TidsskriftFrontiers in Neurology
Vol/bind12
ISSN1664-2295
DOI
StatusUdgivet - 2021

Bibliografisk note

Funding Information:
This study was supported by grants from the Philippine Institute for Traditional and Alternative Health Care (PITHAC) of the Department of Health. The contributions of SC are partly supported by the Ministry of Education, Singapore, Academic Research Fund (MOE2019-T2-1-019). The funding agencies did not have any role in the study design, nor will they have any role in the implementation or management of the intervention, data collection, analysis and interpretation, manuscript writing, and dissemination of results.

Funding Information:
The investigators acknowledged the cooperation of the Office of the Senior Citizens Affairs (OSCA) of Quezon City, Philippines.

Publisher Copyright:
© Copyright © 2021 Dominguez, de Guzman, Chen, Sano, Waldemar and Phung.

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