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

Last updated: April 16, 2025
Sponsor: National Taiwan University Hospital
Overall Status: Terminated

Phase

N/A

Condition

Aging

Treatment

N/A

Clinical Study ID

NCT05749913
202301132RIND
  • Ages 65-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 andTaiwanese.

  3. No severe depression, or other neurological/mental disorders affectingcognitive 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 andTaiwanese.

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

  4. Use two questions to screen: "Compared with the previous situation, do you havememory problems?", "Has your family or relatives ever thought that you have memoryproblems compared with the previous situation?", the answer to both questions isyes.

  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 andTaiwanese.

  3. MCI diagnosed by neurologists or psychiatrists: the diagnosis of MCI is mainly inaccordance with the revised consensus version of the diagnostic criteria (Winblad etal., 2004), that is, memory function score is 1.5 standard deviations below thevalue for age- and education-related norms on the third edition of Wechsler MemoryScale.

  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 andTaiwanese.

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

Exclusion

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 withorganic 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, auditoryimpairment

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 hearingimpaired, or have serious physical disease and behavioral problems.

Study Design

Total Participants: 40
Study Start date:
March 16, 2023
Estimated Completion Date:
May 25, 2023

Study 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.

Connect with a study center

  • College of Medicine, National Taiwan University

    Taipei, 10051
    Taiwan

    Site Not Available

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