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

Primary Purpose

Frailty, Fall, Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Multidomain frailty prevention method
Regular follow up
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kun-Pei LinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Regular follow up

Multidomain intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Fall
fall rate will be evaluated by phone contact to subjects.
Emergency room visits
Emergency room visits will be evaluated by phone contact to subjects.
Hospitalization
Hospitalization times will be evaluated by phone contact to subjects.

Secondary Outcome Measures

Skeletal muscle index
Skeletal muscle index will be measured by Bioelectrical impedance analysis.

Full Information

First Posted
February 7, 2023
Last Updated
February 7, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05731167
Brief Title
Validation and Application of a Multi-dimentional Frailty Assessment Tool-Cohort Intervention and Follow up
Official Title
Validation and Application of a Multi-dimentional Frailty Assessment Tool-Cohort Intervention and Follow up
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Fall, Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regular follow up
Arm Type
Active Comparator
Arm Description
Subjects underwent routine outpatient care after assessment and will receive outcomes follow up for 1 year.
Arm Title
Multidomain intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multidomain frailty prevention method
Intervention Description
We use the nutrition, physical training, medication consultation, cognition training to prevent the occurrence of frailty or other adverse outcome.
Intervention Type
Other
Intervention Name(s)
Regular follow up
Intervention Description
Subjects will receive regular follow up and suggestion in outpatient department.
Primary Outcome Measure Information:
Title
Fall
Description
fall rate will be evaluated by phone contact to subjects.
Time Frame
1 year
Title
Emergency room visits
Description
Emergency room visits will be evaluated by phone contact to subjects.
Time Frame
1 year
Title
Hospitalization
Description
Hospitalization times will be evaluated by phone contact to subjects.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Skeletal muscle index
Description
Skeletal muscle index will be measured by Bioelectrical impedance analysis.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun-Pei Lin, MD
Phone
+886223123456
Ext
67095
Email
dtmed512@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun-Pei Lin, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kun-Pei Lin
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun-Pei Lin, MD
Phone
+886223123456
Ext
67095
Email
dtmed512@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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