NCT06140212

Brief Summary

This study aims to (1) compare the assessment outcome of the ICOPE-I and ICOPE-S, and (2) investigate the correlation between both versions of the ICOPE step 1 screening tools and frailty in Taiwan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

December 2, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

August 12, 2024

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 9, 2023

Last Update Submit

August 8, 2024

Conditions

Keywords

FrailtyICOPEIntrinsic capacityCommunity-dwelling elderly

Outcome Measures

Primary Outcomes (3)

  • Intrinsic capacity

    ICOPE screening tool (self-administration and interview version) would be used to evaluate the intrinsic capacity(IC), including cognitive decline, auditory and visual capabilities, mobility restrictions, nutritional status, and depressive symptoms) of the participants. Each question requires a binary response, either 'yes' or 'no'. A "total score" will be determined by summing the number of IC impairments, which have a score range of 0-6, with higher scores indicating a greater degree of impairment.

    The ICOPE screening tool assessment would take about 10 minutes

  • Phenotype of frailty status

    Frailty criteria by Dr. Fried would be used to evaluate the frail status of the participants.The Dr. Fried phenotype of frailty comprises five components, unintentional weight loss, exhaustion, weakness, slowness, and low activity. Individuals who exhibit three or more indicators are classified as frail, those with one to two indicators are categorized as pre-frail, and those with no indicators are characterized as robust.

    The phenotype of frailty status assessment would take about 10 minutes

  • Accumulated frailty status

    Edmonton frail scale(EFS) would be used to evaluate the frail status of the participants. EFS assesses a wide range of nine domains through 11 questions. These domains cover cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. The total score of EFS ranges from 0 to 17, where scores of 0-5 indicate not being frail, 6-7 indicate being vulnerable, 8-9 indicate mild frailty, 10-11 indicate moderate frailty and 12-17 indicate severe frailty.

    The accumulated frailty status assessment would take about 10 minutes

Secondary Outcomes (1)

  • Cognitive status

    The cognitive status assessment would take about 10 minutes

Study Arms (2)

Decline ICOPE group

The elderly individuals who have at least one impairment in ICOPE screening domains.

Behavioral: Montreal Cognitive Assessment (MoCA)Behavioral: Chinese ICOPE screening tool (self-administration and interview versions)Behavioral: Frailty status assessment (Edmonton frail scale and Frailty criteria by Dr. Fried)

Non-decline ICOPE group

The elderly individuals who do not have any impairment in ICOPE screening domains.

Behavioral: Montreal Cognitive Assessment (MoCA)Behavioral: Chinese ICOPE screening tool (self-administration and interview versions)Behavioral: Frailty status assessment (Edmonton frail scale and Frailty criteria by Dr. Fried)

Interventions

MoCA would be used to assess participants cognitive functioning.

Decline ICOPE groupNon-decline ICOPE group

The ICOPE screening tool would be used to assess participants health status, including cognitive decline, auditory and visual capabilities, mobility restrictions, nutritional status, and depressive symptoms.

Decline ICOPE groupNon-decline ICOPE group

The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status.

Decline ICOPE groupNon-decline ICOPE group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Communities in Taipei city

You may qualify if:

  • ≥ 65 years old
  • Community-dwelling elderly
  • Walking independently (with/without assistive devices)

You may not qualify if:

  • Participants with a MoCA score \< 26
  • Being unable to give informed consent (e.g., aphasia, deafness, and blindness)
  • Being unable to finish all the physical and screening assessment assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Taipei, Zhongzheng, 100, Taiwan

Location

MeSH Terms

Conditions

Frailty

Interventions

Mental Status and Dementia TestsSelf Administration

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesDrug TherapyTherapeuticsSelf Care

Study Officials

  • Li-Ying Wang, PhD

    National Taiwan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 18, 2023

Study Start

December 2, 2023

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

August 12, 2024

Record last verified: 2023-11

Locations