NCT06214962

Brief Summary

The purpose of this stage is to conduct analysis and discussion through expert meetings (consultation) based on the current data of the elderly in each dementia base and Rizhao Center, as well as the weekly courses and activities of the service site (base, Rizhao), and make recommendations.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
652

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2023

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2023

Enrollment Period

3.6 years

First QC Date

March 13, 2023

Last Update Submit

March 19, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • basic information

    Including gender, age, height, weight, marital status, education level, Gender: This pertains to the participant's biological gender and may be identified as either male or female. Age: Represents the participant's age, typically measured in years. Height: The participant's height, typically measured in centimeters or inches. Weight: The participant's weight, typically measured in kilograms or pounds. Marital Status: Describes the participant's current marital status, such as married, unmarried, divorced, etc. Educational Level: This indicates the participant's level of education, including degrees or other educational qualifications. Medical Conditions: Describes the participant's health condition, which may encompass past medical history, current illnesses, or chronic conditions.

    Two weeks before intervention

  • cognitive function assessment

    (SPMSQ - Short Portable Mental Status Questionnaire): Description: SPMSQ, a concise cognitive screening tool, assesses memory and cognitive function via questions on orientation, memory, and mathematical abilities. (Mini-Mental State Examination; MMSE): Description: MMSE, widely used for cognitive function assessment, covers domains like orientation, registration, attention, calculation, recall, language, and visuospatial skills. (Cognitive Abilities Screening Instrument; CASI): Description: CASI, a comprehensive tool, assesses attention, concentration, orientation, short-term memory, language, and visual construction. Scoring: Scores can range from 0 to 100, with higher scores indicating better cognitive function. Specific cutoff scores may be used to identify different levels of cognitive impairment.

    Two weeks before intervention

  • Psychiatric and behavioral symptoms

    Use NPI or other mental behavioral scales that are more suitable for Rizhao elders NPI (Neuropsychiatric Inventory): Description: The NPI is a tool designed to assess neuropsychiatric behaviors, particularly in the elderly. It covers various domains such as hallucinations, anxiety, depression, insomnia, etc., providing insights into the assessed individual's behavioral symptoms. Scoring: Each domain has corresponding scores, and a total score helps assess the severity of neuropsychiatric symptoms.

    Two weeks before intervention

  • daily life functions

    Measured by Pap scale and IADL. Barthel Index: Description: The Barthel Index assesses an individual's activities of daily living and self-care abilities, especially in rehabilitation and residential care settings. It includes basic activities like eating, bathing, dressing, toileting, etc. Scoring: Each activity is assigned specific scores, and the total score is used to evaluate the overall self-care abilities of the individual. Higher scores indicate better daily living skills. IADL (Instrumental Activities of Daily Living): Description: IADL is used to assess more complex daily living skills, such as shopping, cooking, using the phone, handling finances, etc. These skills reflect an individual's level of independence in social and home settings. Scoring: IADL scores are used to evaluate the individual's capabilities in these more complex activities. Higher scores indicate stronger independent abilities.

    Two weeks before intervention

  • body movement function

    Hand Grip Strength: Description: Hand grip strength is a test to assess an individual's hand muscle strength, usually measured using a hand dynamometer. Single Leg Stand: Description: Single leg stand is a test to assess balance and stability, typically requiring the individual to stand on one leg for a certain duration to test their control of the center of gravity. Five Times Sit-to-Stand: Description: This test assesses lower limb strength and the ability to stand up, requiring the individual to stand up and sit down five times to test muscle strength and coordination. Timed Up and Go: Description: Timed Up and Go is a test assessing dynamic balance and walking ability. It requires the individual to stand up from a chair, walk a distance, and then return to sit down. Walking Speed: Description: Walking speed tests assess the individual's speed during walking, serving as an important indicator of daily activity ability and quality of life.

    Two weeks before intervention

Interventions

1. Invite experts to discuss the course content of each unit of MTM, and then invite teachers to take pictures , and combine them into one course for the benefit of the elderly in the institution. 2. Select 3 units to try out in the dementia base, and make corrections based on the feedback of the elders and the base staff. 3. Continue to complete other units based on the experience of the first 3 units. (2) In the Rizhao part, experts are mainly used to develop various course modules suitable for the elderly with dementia in Rizhao, and each module unit is tested on the elderly with dementia and then revised The planning task is mainly to establish a solution strategy. The method is to set up an "activity course module planning or design group" to develop various course modules suitable for Rizhao demented elders.

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The objects of data collection are the elders, their families, and caregivers in the bases and Rizhao. The research team only makes suggestions on the courses in the institutions that are willing to participate, and makes suggestions on the implementation of course activities with the personnel who originally booked the courses. It is not the project that sends people to the base or directly leads the activities in Rizhao. The researchers of this project are Facilitator of course activities and data collector or evaluator of effectiveness items.

You may qualify if:

  • Recruit the elders (and their family members) in community bases and Rizhao centers, caregivers of bases and Rizhao centers.

You may not qualify if:

  • Because the plan hopes to conduct an extensive inventory/detection of the dementia and disability status of the elderly in the dementia stronghold and Rizhao Center, unless the subjects do not want to To join the research, there are no conditions for case scheduling in this plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lih-Jiun Liaw

Kaohsiung City, 807057, Taiwan

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

myotubularin

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Li-Jiun Liaw

    Kaohsiung Medical University Department of Physical Therapy Associate Professor

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

January 22, 2024

Study Start

June 10, 2022

Primary Completion

February 1, 2026

Study Completion

February 28, 2026

Last Updated

March 21, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations