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

NCT05749913 | Terminated

• 1 other identifier: 202301132RIND
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

participation; cognitive activities; cognitive load

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  5-7 minutes

Study Arms (4)

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

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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):
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

College of Medicine, National Taiwan University

Taipei, 10051, Taiwan

Location

Study Officials

• Hui-Fen Mao, M.S.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 1, 2023
• Study Start: March 16, 2023
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: April 20, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)