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

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

Study Overview

• Status: Recruiting
• Conditions: Frailty; Sarcopenia; Fall
• Intervention / Treatment: Other: Regular follow up; Behavioral: Multidomain frailty prevention method

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.

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kun-Pei Lin, MD; Phone Number: 67095 +886223123456; Email: dtmed512@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Kun-Pei Lin
    • Contact: Kun-Pei Lin, MD; Phone Number: 67095 +886223123456; Email: dtmed512@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adults aged greater than 65 years in outpatient department

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular follow up; Subjects underwent routine outpatient care after assessment and will receive outcomes follow up for 1 year.	Other: Regular follow up; Subjects will receive regular follow up and suggestion in outpatient department.
Experimental: Multidomain intervention; 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.	Behavioral: Multidomain frailty prevention method; We use the nutrition, physical training, medication consultation, cognition training to prevent the occurrence of frailty or other adverse outcome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall	fall rate will be evaluated by phone contact to subjects.	1 year
Emergency room visits	Emergency room visits will be evaluated by phone contact to subjects.	1 year
Hospitalization	Hospitalization times will be evaluated by phone contact to subjects.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle index	Skeletal muscle index will be measured by Bioelectrical impedance analysis.	1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Kun-Pei Lin, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 7, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Estimate): February 16, 2023

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Frailty; Sarcopenia
• Other Study ID Numbers: 202112187RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No