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

October 27, 2022 updated by: Yi-Chun Kuan, Taipei Medical University Shuang Ho Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
380

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235
        • Recruiting
        • Taipei Medical University-Shuang Ho Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Behavioral: multi-modal non-pharmacological intervention
multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs
ACTIVE_COMPARATOR: 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.
Behavioral: multi-modal non-pharmacological intervention
multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs
PLACEBO_COMPARATOR: Control
The control group will also receive the same health evaluation and education as all intervention groups.
Behavioral: multi-modal non-pharmacological intervention
multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in cognition including individual cognitive domains, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
A composite z-score will be obtained from the neuropsychological tests evaluating multiple cognitive domains, including memory, language, process speed, visuospatial, and executive function.
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in physical assessment, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Senior Fitness Test (SFT) measures six functional areas of physical function (strength, endurance, balance, agility, and flexibility)
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in physical assessment, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Short Physical Performance Battery (SPPB), score range: 0-12; higher scores mean a better outcome.
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in physical assessment, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in physical functioning - Hand-grip strength, kg
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Measured using a hand-grip dynamometer
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change of the questionnaire regarding the nutrition, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Mini Nutritional Assessment-Short Form (MNA-SF), a screening scale used to assess current nutritional status. score range: 0-14, higher scores mean a better outcome.
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change of the questionnaire regarding the nutrition, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
food frequency questionnaire (FFQ), a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change of nutrition intake, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
3-day dietary record: a self-reported account of all foods and beverages consumed within recent three days
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in functioning level, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Activities of Daily Living Questionnaire (ADLQ)
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in functioning level, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA-Brief) -Traditional Chinese Version: two subdomains (Finances, Communication) with a total score ranging from 0 to 100.
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in functioning level, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Florida Cognitive Activities Scale (FCAS): a 25-item scale used to assess cognitive activities in the elderly with two subscales (Higher Cognitive Abilities and Frequent Cognitive Abilities)
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in functioning level, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
EuroQol five-dimensional (EQ-5D): an instrument for measuring quality of life regarding the five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in functioning level, unit on a scale
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Activities of Daily Living Questionnaire (ADLQ), The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment（Traditional Chinese Version）（UPSA-Brief）, Florida Cognitive Activities Scale(FCAS), EuroQol five-dimensional (EQ-5D)
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in depressive symptoms, unit on a scale.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Geriatric Depression Scale-Short Form (GDS-S), score range: 0-15; higher scores mean a worse outcome.
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in sleep symptoms, unit on a scale.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Epworth sleepiness scale (ESS)
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in sleep symptoms, unit on a scale.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Pittsburgh Sleep Quality Index (PSQI)
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in blood tests - fasting plasma glucose, mmol/L.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Measured from fasting blood sample
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in blood tests - triglycerides, mmol/L.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Measured from fasting blood sample
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change in blood tests - Albumin, prealbumin, g/dL.
Time Frame: Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Measured from fasting blood sample
Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)
Change of Plasma amyloid beta, pg/mL
Time Frame: Before intervention (Baseline); During intervention (6th month and 24th month)
Assessed by ultra-sensitive, immunomagnetic reduction assay (MagQu, LLC, Surprise, AZ),
Before intervention (Baseline); During intervention (6th month and 24th month)
Change of Plasma tau, pg/mL
Time Frame: Before intervention (Baseline); During intervention (6th month and 24th month)
Assessed by ultra-sensitive, immunomagnetic reduction assay (MagQu, LLC, Surprise, AZ),
Before intervention (Baseline); During intervention (6th month and 24th month)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University Shuang Ho Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N202112075

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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