Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention

NCT ID: NCT05407857

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-12-31

Brief Summary

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A 3-arm randomized controlled trial of multi-modal non-pharmacological Intervention for preventing the risk of dementia in Taiwanese geriatric people

Detailed Description

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This project proposes an intervention program for dementia prevention based on the Taiwanese model. The investigator(s) will screen the elderly who are not yet demented but are at high risk of dementia and will randomly allocate them into three groups (on site intervention group, remote intervention group, and control group) for a two-year multi-modal non-pharmacological intervention. All intervention groups will be actively involved in management with nutrition, exercise and cognitive programs. The on-site intervention group requires subjects to participate in prescribed place according to the protocol. The remote intervention group is designed for reducing the chances of person-to-person contact response to the current coronavirus disease 2019 (COVID-19) pandemic and development of digital internet. It uses innovative technology combining wearable devices with inertial measurement units, blue-tooth equipment, apps, feedback technology and artificial intelligence based remote comprehensive training programs. During the study period, each group will be regularly monitored the changes of cardiovascular risk factors, physical performance and cognitive function. The results of multimodal intervention mainly from Taipei and New Taipei City will establish the Taiwan FINGER model (TaiPEI) and will have the information of the conditions and feasibility achieved in Taiwan and implementation suggestions in the face of the epidemic. It can be subsequently applied to the brain/body health care institution and to the prevention of dementia and cardiovascular disease of elderly.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups (on site intervention group, remote intervention group, and control group)
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
We will avoid all the outcomes assessors knowing the allocation and intervention groups.

The participant will only know what treatment is applied until the start of the intervention. We will also suggest the participants not to discuss their interventions and restrict the chance of communication between different intervention groups.

Study Groups

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On-site

The on-site multi-modal intervention will be actively involved in management with nutrition, exercise and cognitive programs. The on-site intervention group requires subjects to participate in prescribed place according to the protocol.

Group Type EXPERIMENTAL

multi-modal non-pharmacological intervention

Intervention Type BEHAVIORAL

multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs

Remote

The remote intervention group is designed for reducing the chances of person-to-person contact response to the current COVID-19 pandemic and development of digital internet. It uses innovative technology combining wearable devices with inertial measurement units, blue-tooth equipment, apps, feedback technology and artificial intelligence based remote comprehensive training programs.

Group Type ACTIVE_COMPARATOR

multi-modal non-pharmacological intervention

Intervention Type BEHAVIORAL

multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs

Control

The control group will also receive the same health evaluation and education as all intervention groups.

Group Type PLACEBO_COMPARATOR

multi-modal non-pharmacological intervention

Intervention Type BEHAVIORAL

multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs

Interventions

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multi-modal non-pharmacological intervention

multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. People over 60 without dementia
2. Agree to join the study and sign the consent form
3. The Modified Rankin Scale (MRS) scores between 0-1 points
4. Education level: elementary or higher education (6 years) or can read and write Chinese
5. Very early dementia screening scale (AD-8) \< 2, or more than 2 points but without dementia diagnoses after refer to a neurologist.
6. Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score: above 8; diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD) in the past six months.

Exclusion Criteria

1. Have been diagnosed with any kind of dementia
2. Suspected dementia patients or others who are not suitable to participate in the research assessed by a doctor at the first visit
3. Diseases affecting the safety of various interventional activities (such as remaining life less than two years, symptomatic heart/cerebrovascular disease within 6 months, vascular reperfusion or reconstruction-related surgery within one year, etc., malignant tumor within one year)
4. Severe blindness, hearing or communication impairment, or other difficulty in cooperating or completing assessments and interventions (especially exercise) in the study
5. Severe mental illnesses, including major depression disorder, or major neuromusculoskeletal disorders that are not suitable to join the study.
6. Drug or alcohol abuse in the last year
7. Overlapping with other interventional trials at the same time which may affect the evaluation results.
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi-Chun Kuan

Physician, Department of Neurology, Principal Investigator, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi-Chun Kuan, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

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Taipei Medical University-Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yi-Chun Kuan, MD

Role: CONTACT

+886-222490088 ext. 8112

Facility Contacts

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Yi-Chun Kuan

Role: primary

0970747553

Other Identifiers

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N202112075

Identifier Type: -

Identifier Source: org_study_id

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