Cognitive Load of Activity Participation Scale (CLAP): Development and Validation

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05749913
• Collaborator: (none)
• Enrollment: 510
• Location: 1
• Anticipated Duration (Months): 41
• Patients Per Site Per Month: 12.4

Study Details

Study Description

Brief 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 to preventing and delaying dementia.

Condition or Disease	Intervention/Treatment	Phase
Aging

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

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 510 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Cognitive Load of Activity Participation Scale (CLAP): Development and Validation
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Feb 6, 2026
• Anticipated Study Completion Date: Jul 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Normal Participants living in the community. No vision or hearing impairment. No severe depression, or other neurological/mental disorders affecting cognitive function.
Subjective Cognitive Decline, SCD 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 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 has met the criteria of dementia at the early stages

Outcome Measures

Primary Outcome Measures

1. The Montreal Cognitive Assessment(MoCA) [10-15 mins]

   The Montreal Cognitive Assessment (MoCA) is a sensitive tool for screening cognitive function in the early stages of cognitive degeneration.

2. Geriatric Depression Scale-Short Form (GDS-S) [5-7 minutes]

   There are 15 questions for elderly in GDS-S used for screening depression state. It takes 5-7 minutes to complete.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Years 1 and 2 of study:

1. Participants living in the community, aged 65 or above.

2. No vision or hearing impairment, able to communicate and read in Mandarin and Taiwanese.

3. No severe depression, or other neurological/mental disorders affecting cognitive function.

• Third year of study:

Subjective Cognitive Degeneration (SCD):

1. Participants living in the community, aged 65 or above.

2. No vision or hearing impairment, able to communicate and read in Mandarin and Taiwanese.

3. The Montreal Cognitive Assessment (MoCA) score >22

4. 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.

5. Geriatric Depression Scale-Short Form (GDS-S) score <8

Mild Cognitive Impairment (MCI):

1. Participants living in the community, aged 65 or above.

2. No vision or hearing impairment, able to communicate and read in Mandarin and Taiwanese.

3. 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.

4. MoCA: with a range of scores of 17-23(>17, <23) (Trzepacz et al., 2015)

5. Geriatric Depression Scale-Short Form (GDS-S) score <8

Mild Dementia:

1. Participants living in the community, aged 65 or above.

2. No vision or hearing impairment, able to communicate and read in Mandarin and Taiwanese.

3. Those who have met the diagnostic criteria for mild dementia are referred by the neurologist or psychiatrist.

Exclusion Criteria:

• Years 1 and 2 of study:

1. 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.

2. People with serious mental illness or behavior problems.

• Third year of study:

SCD:

1. Cognitive changes caused by other mental, neurological diseases, or substance abuse, etc.

2. Has met the diagnostic criteria of MCI or dementia

3. Those who are unable to complete the cognitive test due to visual, auditory, physical or cognitive impairment

MCI:

1. Cognitive changes caused by other mental, neurological diseases, or substance abuse, etc.

2. Has met the diagnostic criteria for dementia.

3. Those who are unable to complete the cognitive test due to visual, auditory impairment

Mild Dementia:

1. Cognitive changes caused by other mental, neurological diseases, or substance abuse, etc.

2. Those who cannot accept the cognitive test because they are visually or hearing impaired, or have serious physical disease and behavioral problems.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	College of Medicine, National Taiwan University	Taipei		Taiwan	10051

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Hui-Fen Mao, M.S., National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05749913
• Other Study ID Numbers: 202301132RIND
• First Posted: Mar 1, 2023
• Last Update Posted: Mar 1, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital: participation; cognitive activities; cognitive load

Study Results

No Results Posted as of Mar 1, 2023