Community-dwelling ElderlyNCT06140212
Exploring the Relationship Between ICOPE Framework and Frailty Among Community-dwelling Elderly Individuals
An observational study of Community-dwelling Elderly, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community-dwelling Elderly
- What is being tested?
- Montreal Cognitive Assessment (MoCA), Chinese ICOPE screening tool (self-administration and interview versions) and Frailty status assessment (Edmonton frail scale and Frailty criteria by Dr. Fried)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 135 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Dec 2023to 25 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Communities in Taipei city
Who may be able to join
- ≥ 65 years old
- Community-dwelling elderly
- Walking independently (with/without assistive devices)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei, Zhongzheng, 100
About this study
Official title: Exploring the Relationship Between the Integrated Care for Older People (ICOPE) Framework and Frailty Among Community-dwelling Elderly Individuals
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.
Read the detailed description
The prevalence of frailty among the elderly increases annually as the population ages. The World Health Organization (WHO) has introduced the Integrated Care for Older People (ICOPE) framework, which aims to support healthy aging by evaluating the intrinsic capacity (IC) of the elderly in six different areas. In Taiwan, two versions of the ICOPE step 1 screening tools are available: an interview-based version (ICOPE-I) and a self-administered version (ICOPE-S) based on the WHO's model. There are two main models for frailty status assessments: Dr. Fried's phenotype of frailty and Dr. Rockwood's accumulation of deficit models. A comparative study is necessary to assess the consistency of both versions of ICOPE in Taiwan and their associations with frailty.
- Conditions
- Community-dwelling Elderly
- Being tested
- Montreal Cognitive Assessment (MoCA), Chinese ICOPE screening tool (self-administration and interview versions), Frailty status assessment (Edmonton frail scale and Frailty criteria by Dr. Fried)
- Keywords
- Frailty, ICOPE, Intrinsic capacity, Community-dwelling elderly
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montreal Cognitive Assessment (MoCA)Behavioural
MoCA would be used to assess participants cognitive functioning.
Chinese ICOPE screening tool (self-administration and interview versions)Behavioural
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.
Frailty status assessment (Edmonton frail scale and Frailty criteria by Dr. Fried)Behavioural
The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status.
| Study group | Role | What they receive |
|---|---|---|
| Decline ICOPE group | The elderly individuals who have at least one impairment in ICOPE screening domains. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The accumulated frailty status assessment would take about 10 minutes
Secondary outcomes (1)
Cognitive status
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.
Measured: The cognitive status assessment would take about 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start2 Dec 2023
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-dwelling ElderlyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Ying Wang, PhD, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140212
- Sponsor's protocol ID
- 202310067RINC
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between the Integrated Care for Older People (ICOPE) Framework and Frailty Among Community-dwelling Elderly Individuals
- ClinicalTrials.gov ID
- NCT06140212
- Acronym / sponsor ID
- 202310067RINC
- Conditions
- Community-dwelling Elderly
- Keywords
- Frailty, ICOPE, Intrinsic capacity, Community-dwelling elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prevalence of frailty among the elderly increases annually as the population ages. The World Health Organization (WHO) has introduced the Integrated Care for Older People (ICOPE) framework, which aims to support healthy aging by evaluating the intrinsic capacity (IC) of the elderly in six different areas. In Taiwan, two versions of the ICOPE step 1 screening tools are available: an interview-based version (ICOPE-I) and a self-administered version (ICOPE-S) based on the WHO's model. There are two main models for frailty status assessments: Dr. Fried's phenotype of frailty and Dr. Rockwood's accumulation of deficit models. A comparative study is necessary to assess the consistency of both versions of ICOPE in Taiwan and their associations with frailty.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decline ICOPE group | – | 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)The elderly individuals who have at least one impairment in ICOPE screening domains. |
| Non-decline ICOPE group | – | 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)The elderly individuals who do not have any impairment in ICOPE screening domains. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Communities in Taipei city
Key inclusion criteria (3 listed)
- ≥ 65 years old
- Community-dwelling elderly
- Walking independently (with/without assistive devices)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montreal Cognitive Assessment (MoCA)MoCA would be used to assess participants cognitive functioning. | Behavioural | Decline ICOPE group, Non-decline ICOPE group |
| Chinese ICOPE screening tool (self-administration and interview versions)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. | Behavioural | Decline ICOPE group, Non-decline ICOPE group |
| Frailty status assessment (Edmonton frail scale and Frailty criteria by Dr. Fried)The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status. | Behavioural | Decline ICOPE group, Non-decline ICOPE group |
Primary outcome
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.
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.
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.
1 secondary outcome
Cognitive status
Time frame: The cognitive status assessment would take about 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Ying Wang, PhD study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-dwelling Elderly, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrinsic capacity (time frame: The ICOPE screening tool assessment would take about 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.