Dementia
Conditions
Brief summary
A 3-arm randomized controlled trial of multi-modal non-pharmacological Intervention for preventing the risk of dementia in Taiwanese geriatric people
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.
Interventions
BEHAVIORALmulti-modal non-pharmacological intervention
multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs
Sponsors
Taipei Medical University Shuang Ho Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Three groups (on site intervention group, remote intervention group, and control group)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognition including individual cognitive domains, unit on a scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical functioning - Hand-grip strength, kg | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | Measured using a hand-grip dynamometer |
| Change of the questionnaire regarding the nutrition, unit on a scale | 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. |
| Change of nutrition intake, unit on a scale | 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 |
| Change in functioning level, unit on a scale | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | Activities of Daily Living Questionnaire (ADLQ) |
| Change in depressive symptoms, unit on a scale. | 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. |
| Change in physical assessment, unit on a scale | 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) |
| Change in blood tests - fasting plasma glucose, mmol/L. | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | Measured from fasting blood sample |
| Change in blood tests - triglycerides, mmol/L. | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | Measured from fasting blood sample |
| Change in blood tests - Albumin, prealbumin, g/dL. | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | Measured from fasting blood sample |
| Change of Plasma amyloid beta, pg/mL | Before intervention (Baseline); During intervention (6th month and 24th month) | Assessed by ultra-sensitive, immunomagnetic reduction assay (MagQu, LLC, Surprise, AZ), |
| Change of Plasma tau, pg/mL | Before intervention (Baseline); During intervention (6th month and 24th month) | Assessed by ultra-sensitive, immunomagnetic reduction assay (MagQu, LLC, Surprise, AZ), |
| Change in sleep symptoms, unit on a scale. | Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends) | Epworth sleepiness scale (ESS) |
Countries
Taiwan
Contacts
Primary ContactYi-Chun Kuan, MD
Outcome results
None listed