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NCT05749913
Cognitive Load of Activity Participation Scale (CLAP): Development and Validation
Conditions: Aging
Sex: All
Ages: 65 Years – 99 Years
Healthy volunteers: 1
Enrollment: 510
Sponsor: National Taiwan University Hospital
Location: Taiwan
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 Criteria: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 >22Use 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 <8Mild 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 <8Mild 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.Exclusion Criteria: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 dementiaThose who are unable to complete the cognitive test due to visual, auditory, physical or cognitive impairmentMCI: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 impairmentMild 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.
Source: ClinicalTrials.gov (NCT05749913). StuddyBuddy aggregates publicly available trial information.