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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05731167
Enrollment
216
Registered
2023-02-16
Start date
2023-02-07
Completion date
2025-07-31
Last updated
2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall, Frailty, Sarcopenia

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.

Interventions

BEHAVIORALMultidomain frailty prevention method

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

OTHERRegular follow up

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fall1 yearfall rate will be evaluated by phone contact to subjects.
Emergency room visits1 yearEmergency room visits will be evaluated by phone contact to subjects.
Hospitalization1 yearHospitalization times will be evaluated by phone contact to subjects.

Secondary

MeasureTime frameDescription
Skeletal muscle index1 yearSkeletal muscle index will be measured by Bioelectrical impedance analysis.

Countries

Taiwan

Contacts

Primary ContactKun-Pei Lin, MD
dtmed512@gmail.com+886223123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026