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

NCT ID: NCT05731167

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2025-07-31

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.

Conditions

Frailty; Fall; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Regular follow up

Subjects underwent routine outpatient care after assessment and will receive outcomes follow up for 1 year.

Group Type: ACTIVE_COMPARATOR

Regular follow up

Intervention Type: OTHER

Subjects will receive regular follow up and suggestion in outpatient department.

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.

Group Type: EXPERIMENTAL

Multidomain frailty prevention method

Intervention Type: BEHAVIORAL

We use the nutrition, physical training, medication consultation, cognition training to prevent the occurrence of frailty or other adverse outcome.

Interventions

Multidomain frailty prevention method

We use the nutrition, physical training, medication consultation, cognition training to prevent the occurrence of frailty or other adverse outcome.

Intervention Type: BEHAVIORAL

Regular follow up

Subjects will receive regular follow up and suggestion in outpatient department.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kun-Pei Lin, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Kun-Pei Lin

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Kun-Pei Lin, MD

Role: CONTACT

dtmed512@gmail.com

+886223123456 ext. 67095

Facility Contacts

Kun-Pei Lin, MD

Role: primary

dtmed512@gmail.com

+886223123456 ext. 67095

Other Identifiers

202112187RIND

Identifier Type: -

Identifier Source: org_study_id