Validation and Application of a Multi-dimentional Frailty Assessment Tool-Cohort Intervention and Follow up

Not Applicable

Recruiting

• Conditions: Sarcopenia; Frailty; Fall
• Interventions: Other: Regular follow up; Behavioral: Multidomain frailty prevention method

• Registration Number: NCT05731167
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

We aim to (1) use a multifaceted, frailty assessment model. (2) use randomized controlled trials to deal with and intervene with cross-field, multi-faceted and intelligent remote management strategies for the elderly with different degrees of frailty, to further observe functional changes and analyze the probability of adverse prognosis such as falls, hospitalization, and death in the future

Detailed Description

Background: Frailty is a common problem among the elderly, and it is closely related to their own age, chronic diseases, physical function, and nutritional status. The higher the incidence, the higher the age. Frailty is also associated with many adverse outcomes, such as falls, disability and even mortality. At present, there is no ideal treatment for frailty. It is best to start with prevention and take precautions against various frailty factors in advance. There are two types of frailty assessments in this study. The Clinical Frailty Scale is a single observational assessment method, which can roughly know your frailty degree. Frailty indicators are further combined with questionnaires and instrumental measurements, which can be subdivided to explore different weaknesses such as subjective frailty, objective frailty, sarcopenia, osteoporosis risk, and fall risk for analysis.

Objects: Elderly people in the community (over 65 years old) who seek medical treatment in the Geriatrics Department of National Taiwan University Hospital, and who are willing to accept the frailty index test are eligible for admission. We expect to enroll about 216 cases from 2023.2.1 to 2024.12.31 with intervene and follow up for 1 year.

Method:. All the elders were given questionnaires and instruments to measure various frailty indicators, such as walking speed, standing up and walking test, muscle mass index, grip strength, 5 times of sitting and standing speed, and various physiological indicators such as blood oxygen, body fat, etc. The subjects will be randomly assigned to the intervention group or the control group. The control group will receive routine outpatient care. The intervention group will receive multi-faceted frailty prevention and treatment programs such as physical exercises, nutritional advice, cognitive training, and drug education. After that, the prognosis will be tracked by telephone every 3 months, and the self-evaluation questionnaire and the measurement of frailty indicators will be carried out at the 6th and 12th months. In order to observe the changes in the prognosis and frailty indicators of the two groups in one year.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-07
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• adults aged greater than 65 years in outpatient department

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Exclusion Criteria

• with dementia
• with active cancer and those unable to operate or follow measuring instructions.
• Individuals with pacemakers or metal implants were excluded because those devices may interfere with measurement of body composition using the bioelectrical impedance analysis (BIA) technique

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular follow up	Regular follow up	Subjects underwent routine outpatient care after assessment and will receive outcomes follow up for 1 year.
Multidomain intervention	Multidomain frailty prevention method	The intervention group will receive multi-faceted frailty prevention programs such as physical training, nutritional advice, cognitive training, and drug education and receive outcomes follow up for 1 year.

Primary Outcome Measures

Name	Time	Method
Hospitalization	1 year	Hospitalization times will be evaluated by phone contact to subjects.
Fall	1 year	fall rate will be evaluated by phone contact to subjects.
Emergency room visits	1 year	Emergency room visits will be evaluated by phone contact to subjects.

Secondary Outcome Measures

Name	Time	Method
Skeletal muscle index	1 year	Skeletal muscle index will be measured by Bioelectrical impedance analysis.

Trial Locations

Locations (1)

Kun-Pei Lin; 🇨🇳 Taipei, Taiwan