Clinical trial NCT05749913: Cognitive Load of Activity Participation Scale (CLAP): Development and Validation
Official title: Cognitive Load of Activity Participation Scale (CLAP): Development and Validation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aging
Keywords: participation
cognitive activities
cognitive load
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Montreal Cognitive Assessment(MoCA)
timeFrame: 10-15 mins
measure: Geriatric Depression Scale-Short Form (GDS-S)
timeFrame: 5-7 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: College of Medicine, National Taiwan University
Study officials:
affiliation: National Taiwan University Hospital
name: Hui-Fen Mao, M.S.
role: PRINCIPAL_INVESTIGATOR
References: