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

NCT05731167 | Unknown

• 1 other identifier: 202112187RIND
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Conditions

Frailty; Fall; Sarcopenia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Skeletal muscle index

  1 year

Study Arms (2)

Regular follow up

ACTIVE COMPARATOR

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

Other: Regular follow up

Multidomain intervention

EXPERIMENTAL

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

Interventions

Multidomain frailty prevention method BEHAVIORAL

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

Multidomain intervention

Regular follow up OTHER

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

Regular follow up

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• adults aged greater than 65 years in outpatient department

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Kun-Pei Lin

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Kun-Pei Lin, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun-Pei Lin, MD

CONTACT

+886223123456; dtmed512@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: February 7, 2023
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

TW (1)