AgingNCT05749913
Cognitive Load of Activity Participation Scale (CLAP): Development and Validation
An observational study of Aging, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In this study, we develop and validate the " Cognitive Load of Activity Participation Scale" (CLAPs) to measure the frequency and the perceived levels of cognitive load of the elderly participating in various cognitive activities and as a reference for intervention and behavioral Indicators for lifestyle modifications… Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2023to 25 May 2023
- How long will I take part?
- 14 Days
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Normal: No vision or hearing impairment, and no severe depression, or other neurological/mental disorders affecting cognitive function SCD: Use two questions to screen: "Compared with the previous situation, do you have memory problems?", "Has your family or relatives ever thought that you have memory problems compared with the previous situation?", the answer to both questions is yes. MCI: meet the criteria of Mild Cognitive Impairment Mild Dementia: meet the criteria of dementia
Who may be able to join
- Years 1 and 2 of study:
- Participants living in the community, aged 65 or above.
- No vision or hearing impairment, able to communicate and read in Mandarin and Taiwanese.
- No severe depression, or other neurological/mental disorders affecting cognitive function.
- Third year of study:
- Subjective Cognitive Degeneration (SCD):
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- Participants living in the community, aged 65 or above.
- No vision or hearing impairment, able to communicate and read in Mandarin and Taiwanese.
- The Montreal Cognitive Assessment (MoCA) score >22
- Use two questions to screen: "Compared with the previous situation, do you have memory problems?", "Has your family or relatives ever thought that you have memory problems compared with the previous situation?", the answer to both questions is yes.
- Geriatric Depression Scale-Short Form (GDS-S) score <8
- Mild Cognitive Impairment (MCI):
- Participants living in the community, aged 65 or above.
- No vision or hearing impairment, able to communicate and read in Mandarin and Taiwanese.
- MCI diagnosed by neurologists or psychiatrists: the diagnosis of MCI is mainly in accordance with the revised consensus version of the diagnostic criteria (Winblad et al., 2004), that is, memory function score is 1.5 standard deviations below the value for age- and education-related norms on the third edition of Wechsler Memory Scale.
- MoCA: with a range of scores of 17-23(>17, <23) (Trzepacz et al., 2015)
- Geriatric Depression Scale-Short Form (GDS-S) score <8
- Mild Dementia:
- Participants living in the community, aged 65 or above.
- No vision or hearing impairment, able to communicate and read in Mandarin and Taiwanese.
- Those who have met the diagnostic criteria for mild dementia are referred by the neurologist or psychiatrist.
Who cannot join
- Years 1 and 2 of study:
- Have a history of diseases related to cognitive degeneration (for example: acute stroke, brain injury, unconsciousness, etc.), and those diagnosed with organic nerve damage, brain function disorders, and related neurology.
- People with serious mental illness or behavior problems.
- Third year of study:
- SCD:
- Cognitive changes caused by other mental, neurological diseases, or substance abuse, etc.
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- Has met the diagnostic criteria of MCI or dementia
- Those who are unable to complete the cognitive test due to visual, auditory, physical or cognitive impairment
- MCI:
- Cognitive changes caused by other mental, neurological diseases, or substance abuse, etc.
- Has met the diagnostic criteria for dementia.
- Those who are unable to complete the cognitive test due to visual, auditory impairment
- Mild Dementia:
- Cognitive changes caused by other mental, neurological diseases, or substance abuse, etc.
- Those who cannot accept the cognitive test because they are visually or hearing impaired, or have serious physical disease and behavioral problems.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, we develop and validate the " Cognitive Load of Activity Participation Scale" (CLAPs) to measure the frequency and the perceived levels of cognitive load of the elderly participating in various cognitive activities and as a reference for intervention and behavioral Indicators for lifestyle modifications to preventing and delaying dementia.
Read the detailed description
The purpose of this study in the first year is to develop the first version of the CLAPs by literature review, focus group discussion, expert validity, etc., to collect the typical participation in daily and housework activities, social leisure and entertainment, work and learning activities of the elderly. And we also evaluate the level of cognitive load of subjective feelings when individuals participate in activities. In the second year, the aim is to complete the final version of the CLAPs, which is expected to collect 300 subjects in the first version. According to the results, we analyze and select the items and verify the psychometric characteristics, including test-retest reliability and construct validity (factor analysis and convergent validity). In the third year, we will recruit 150 people over 65 with different cognitive levels, including subjective cognitive decline, mild cognitive impairment, and mild dementia, to validate the discriminant validity. The CLAPs will provide an understanding of the cognitive activity profile of the person and as a guide for interventions and an outcome measure.
- Conditions
- Aging
- Keywords
- participation, cognitive activities, cognitive load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | 1. Participants living in the community. 2. No vision or hearing impairment. 3. No severe depression, or other neurological/mental disorders affecting cognitive function. | |
| Subjective Cognitive Decline, SCD | 1. The Montreal Cognitive Assessment (MoCA) score >22 2. Use two questions to screen: "Compared with the previous situation, do you have memory problems?", "Has your family or relatives ever thought that you have memory problems compared with the previous situation?", the answer to both questions is yes. 3. Geriatric Depression Scale-Short Form (GDS-S) score <8 | |
| Mild Cognitive Impairment, MCI | 1. MCI diagnosed by neurologists or psychiatrists: the diagnosis of MCI is mainly in accordance with the revised consensus version of the diagnostic criteria (Winblad et al., 2004), that is, memory function score is 1.5 standard deviations below the value for age- and education-related norms on the third edition of Wechsler Memory Scale. 2. MoCA: with a range of scores of 17-23(>17 , <23) (Trzepacz et al., 2015) 3. Geriatric Depression Scale-Short Form (GDS-S) score <8 | |
| Mild Dementia | 1. has met the criteria of dementia 2. at the early stages |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Montreal Cognitive Assessment(MoCA)
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for screening cognitive function in the early stages of cognitive degeneration.
Measured: 10-15 mins
Geriatric Depression Scale-Short Form (GDS-S)
There are 15 questions for elderly in GDS-S used for screening depression state. It takes 5-7 minutes to complete.
Measured: 5-7 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start16 Mar 2023
- Primary completion25 May 2023
- Study completion25 May 2023
Why it stopped: The research has been transferred to another project leader.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- 40 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Fen Mao, M.S., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749913
- Sponsor's protocol ID
- 202301132RIND
- Status last verified
- May 2024
- First submitted
- 20 Feb 2023
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ethical issue
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Load of Activity Participation Scale (CLAP): Development and Validation
- ClinicalTrials.gov ID
- NCT05749913
- Acronym / sponsor ID
- 202301132RIND
- Conditions
- Aging
- Keywords
- participation, cognitive activities, cognitive load
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The research has been transferred to another project leader.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 1 Mar 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.
In this study, we develop and validate the " Cognitive Load of Activity Participation Scale" (CLAPs) to measure the frequency and the perceived levels of cognitive load of the elderly participating in various cognitive activities and as a reference for intervention and behavioral Indicators for lifestyle modifications to preventing and delaying dementia.
Detailed description
The purpose of this study in the first year is to develop the first version of the CLAPs by literature review, focus group discussion, expert validity, etc., to collect the typical participation in daily and housework activities, social leisure and entertainment, work and learning activities of the elderly. And we also evaluate the level of cognitive load of subjective feelings when individuals participate in activities. In the second year, the aim is to complete the final version of the CLAPs, which is expected to collect 300 subjects in the first version. According to the results, we analyze and select the items and verify the psychometric characteristics, including test-retest reliability and construct validity (factor analysis and convergent validity). In the third year, we will recruit 150 people over 65 with different cognitive levels, including subjective cognitive decline, mild cognitive impairment, and mild dementia, to validate the discriminant validity. The CLAPs will provide an understanding of the cognitive activity profile of the person and as a guide for interventions and an outcome measure.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 14 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –1. Participants living in the community. 2. No vision or hearing impairment. 3. No severe depression, or other neurological/mental disorders affecting cognitive function. |
| Subjective Cognitive Decline, SCD | – | –1. The Montreal Cognitive Assessment (MoCA) score >22 2. Use two questions to screen: "Compared with the previous situation, do you have memory problems?", "Has your family or relatives ever thought that you have memory problems compared with the previous situation?", the answer to both questions is yes. 3. Geriatric Depression Scale-Short Form (GDS-S) score <8 |
| Mild Cognitive Impairment, MCI | – | –1. MCI diagnosed by neurologists or psychiatrists: the diagnosis of MCI is mainly in accordance with the revised consensus version of the diagnostic criteria (Winblad et al., 2004), that is, memory function score is 1.5 standard deviations below the value for age- and education-related norms on the third edition of Wechsler Memory Scale. 2. MoCA: with a range of scores of 17-23(>17 , <23) (Trzepacz et al., 2015) 3. Geriatric Depression Scale-Short Form (GDS-S) score <8 |
| Mild Dementia | – | –1. has met the criteria of dementia 2. at the early stages |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Normal: No vision or hearing impairment, and no severe depression, or other neurological/mental disorders affecting cognitive function SCD: Use two questions to screen: "Compared with the previous situation, do you have memory problems?", "Has your family or relatives ever thought that you have memory problems compared with the previous situation?", the answer to both questions is yes. MCI: meet the criteria of Mild Cognitive Impairment Mild Dementia: meet the criteria of dementia
Key inclusion criteria (21 listed)
- Years 1 and 2 of study:
- Third year of study:
- Participants living in the community, aged 65 or above.
- No vision or hearing impairment, able to communicate and read in Mandarin and Taiwanese.
- The Montreal Cognitive Assessment (MoCA) score >22
Key exclusion criteria (15 listed)
- Years 1 and 2 of study:
- Third year of study:
- Cognitive changes caused by other mental, neurological diseases, or substance abuse, etc.
- Has met the diagnostic criteria of MCI or dementia
- Those who are unable to complete the cognitive test due to visual, auditory, physical or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Montreal Cognitive Assessment(MoCA)
Time frame: 10-15 mins
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for screening cognitive function in the early stages of cognitive degeneration.
Geriatric Depression Scale-Short Form (GDS-S)
Time frame: 5-7 minutes
There are 15 questions for elderly in GDS-S used for screening depression state. It takes 5-7 minutes to complete.
Results and safety
The study was stopped early (reason given: The research has been transferred to another project leader.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No. ethical issue
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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.
Hui-Fen Mao, M.S. principal investigator
National Taiwan University Hospital
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 Aging, 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 21 inclusion and 15 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: stopped early, as of the sponsor's last update on 20 Apr 2025. 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 was stopped early (reason given: The research has been transferred to another project leader.). Results are not available in the source record.
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?
The Montreal Cognitive Assessment(MoCA) (time frame: 10-15 mins). The study lists 2 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 20 Apr 2025.