Clinical trial NCT06214962: Comprehensive Dementia Management : From Translational Medicine to Innovative Care
Official title: Comprehensive Dementia Management : From Translational Medicine to Innovative Care--Innovative Care Model for Community Care Center and Day-Care Center: Development of Classification Standard for Precision Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Exercise
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2024-01-22
Enrollment: 652
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

Detailed description: (1) Course content confirmation: (A) Continuing the results of the first-stage expert meeting, experts in various fields will be divided into groups to form an "activity curriculum planning group" (such as humanities and society, psychology, medical personnel, family members of dementia, etc.), and based on empirical research (type, Time, frequency, etc.) as a planning basis to develop care plans for different types of community dementia service locations and verify their effectiveness.

According to empirical research, such as for different types (dementia or mixed type) of strongholds or sunshine, plan compulsory (common activity) courses, and plan elective activity courses according to different attributes or needs, such as:

1. Common compulsory activities: physical fitness exercise, cognitive training, physical fitness combined with cognition, etc., and plan the dosage (intensity, each time and weekly frequency, etc.) according to the low, medium and high differences in physical fitness;
2. Elective activity courses: Considering the elder attributes of each service location to plan "group common elective" and "individual elective" activities, such as: integrating favorite music elements and nostalgic elements of personal life experience into "daily life activities" The main activities (such as: planting/gardening, cooking, shopping or going out, etc.

(B) Solicit and establish a connection and cooperation model between the community service organization and surrounding resources (such as clinics, foundations, volunteer groups, universities, etc.) Jointly participate in the care plan of this service agency.

The research team develops modular courses and establishes a professional teacher group for each module to provide teaching materials for service locations and personnel training.

(A) Continuing the results of the first-stage expert meeting, experts in various fields will be divided into groups to form an "activity curriculum planning group" (such as humanities and society, psychology, medical personnel, family members of dementia, etc.), and based on empirical research (type, Time, frequency, etc.) as a planning basis to develop care plans for different types of community dementia service locations and verify their effectiveness.

According to empirical research, such as for different types (dementia or mixed type) of strongholds or sunshine, plan compulsory (common activity) courses, and plan elective activity courses according to different attributes or needs, such as:

1. Common compulsory activities: physical fitness exercise, cognitive training, physical fitness combined with cognition, etc., and plan the dosage (intensity, each time and weekly frequency, etc.) according to the low, medium and high differences in physical fitness;
2. Elective activity courses: Considering the elder attributes of each service location to plan "group common elective" and "individual elective" activities, such as: integrating favorite music elements and nostalgic elements of personal life experience into "daily life activities" The main activities (such as: planting/gardening, cooking, shopping or going out, etc.

(B) Solicit and establish a connection and cooperation model between the community service organization and surrounding resources (such as clinics, foundations, volunteer groups, universities, etc.) Jointly participate in the care plan of this service agency.

(C) The research team develops modular courses and establishes a professional teacher group for each module to provide teaching materials for service sites and personnel empowerment training.

(2) Data collection steps After the stronghold and Rizhao agreed to cooperate with the "Experts' Suggestion on Curriculum Adjustment", the first data collection was carried out, and then the new curriculum adjustment was carried out for three months, and then two data collections were carried out. The researchers conducted at least three to four times on these strongholds and Rizhao data collection (The first complete data collection is completed within one to two weeks before the formal adjustment of the course; the second time is collected within two weeks after the course is implemented for three months; the third time is 6 months after the start of implementation; the fourth time Collected 9-12 months after start of implementation.

(3) Description of the data collection role of the researchers of this project: 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.

(4) Objects and contents of data collection in strongholds and Rizhao Data collection content of the elders, their family members, and care workers in the base and Rizhao, except for the data collection content of the first stage In addition, in order to have a more comprehensive understanding of the changes in the performance of the elderly, the functions in the following table 2. will be collected again.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: basic information
timeFrame: Two weeks before intervention
measure: cognitive function assessment
timeFrame: Two weeks before intervention
measure: Psychiatric and behavioral symptoms
timeFrame: Two weeks before intervention
measure: daily life functions
timeFrame: Two weeks before intervention
measure: body movement function
timeFrame: Two weeks before intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Lih-Jiun Liaw
Study officials:
affiliation: Kaohsiung Medical University Department of Physical Therapy Associate Professor
name: Li-Jiun Liaw
role: STUDY_DIRECTOR
References: