- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06140212
Exploring the Relationship Between ICOPE Framework and Frailty Among Community-dwelling Elderly Individuals
Exploring the Relationship Between the Integrated Care for Older People (ICOPE) Framework and Frailty Among Community-dwelling Elderly Individuals
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zhongzheng
-
Taipei, Zhongzheng, Taiwan, 100
- School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 65 years old
- Community-dwelling elderly
- Walking independently (with/without assistive devices)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Decline ICOPE group
The elderly individuals who have at least one impairment in ICOPE screening domains.
|
MoCA would be used to assess participants cognitive functioning.
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.
The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status.
|
|
Non-decline ICOPE group
The elderly individuals who do not have any impairment in ICOPE screening domains.
|
MoCA would be used to assess participants cognitive functioning.
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.
The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intrinsic capacity
Time Frame: The ICOPE screening tool assessment would take about 10 minutes
|
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
Time Frame: The phenotype of frailty status assessment would take about 10 minutes
|
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.
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The phenotype of frailty status assessment would take about 10 minutes
|
|
Accumulated frailty status
Time Frame: The accumulated frailty status assessment would take about 10 minutes
|
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.
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The accumulated frailty status assessment would take about 10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive status
Time Frame: The cognitive status assessment would take about 10 minutes
|
MoCA would be used to evaluate the cognitive functioning of the participants.
MOCA comprises attention and concentration, executive function, memory, language ability, visuospatial construction, abstract concepts, calculation, and orientation.
The cumulative score amounts to 30 points, with a minimum standard of 26 points or higher.
25-18 points indicate mild cognitive impairment, 17-10 points indicate moderate cognitive impairment, fewer than 10 points indicate severe cognitive impairment.
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The cognitive status assessment would take about 10 minutes
|
Collaborators and Investigators
Investigators
- Study Chair: Li-Ying Wang, PhD, National Taiwan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202310067RINC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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