Cognitive Prefrail and Frailty, and Motoric Cognitive Risk Syndrome: Prevalence and Association With Incident Adverse Health Events

NCT04275817 | Active Not Recruiting

• 1 other identifier: 2020-2183
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

We defined a new and early condition in the spectrum of cognitive frailty: the "cognitive-prefrailty" which is a combination of prefrailty stage and subjective cognitive impairment (SCI). This study aims to: (1) examine and compare the prevalence of cognitive-prefrailty, cognitive frailty and motoric cognitive risk syndrome (MCR) syndromes in participants of the Canadian Longitudinal Study of Aging (CLSA) using the (tracking and comprehensive) baseline assessment, (2) examine the association of cognitive-prefrailty, cognitive frailty and MCR syndromes with incident adverse health events using the information collected during the first CLSA 18-month follow-up, and (3) compare the criteria performances (i.e., sensitivity, specificity, positive predictive value, negative predictive value, area under receiver operating characteristic curve, positive and negative likelihood ratio) for incident adverse health events of the cognitive-prefrailty, cognitive frailty and MCR syndromes.

Conditions

Frailty; Motoric Cognitive Risk Syndrome; Cognitive-prefrailty

Outcome Measures

Primary Outcomes (1)

• Cognitive-prefrailty

  Defined as frailty and subjective cognitive impairment combined. Frailty (as proposed by Fried et al.) will be identified by the presence of ≥ 3 of the 5 components: 1) unintentional weight loss, 2) Weakness (maximal grip strength); 3) Poor energy (answer of "no" to the question "Do you feel full of energy?" from the 15-item Geriatric Depression Scale); 4) Slowness as identified by an average walk speed, and 5) Low physical activity level. Participants with none of the above components will be considered to be vigorous and those with 1 or 2 components will be considered to be in a prefrail stage. SCI will be defined using a proxy for subjective cognitive complaint (i.e. memory complaint) based on standardized memory loss question on the 15-item Geriatric Depression Scale (GDS; "Do you feel you have more problems with memory than most?").

  1 day

Secondary Outcomes (4)

• Falls

  12 months

• Depression

  1 day

• Activities daily living (ADL)

  1 day

• Motoric Cognitive Risk

  1 day

Study Arms (3)

Individuals with prefrailty

This is defined as a co-existing prefrailty using the Fried criteria. Frailty defined by the CHS index as proposed by Fried et al. will be identified by the presence of ≥ 3 of the following 5 components: 1) Shrinking: unintentional weight loss of ≥ 5% between two assessments, 2) Weakness: a maximal grip strength in the lowest quintile stratified by body mass index quartile; 3) Poor energy: answer of "no" to the question "Do you feel full of energy?" from the 15-item Geriatric Depression Scale; 4) Slowness: average walk speed in the lowest quintile stratified by median standing height, and 5) Low physical activity level: PASE score in the lowest quintile. Participants with none of the above components will be considered to be vigorous and those with 1 or 2 components will be considered to be in a prefrail stage.

Other: Data collection

Individuals with cognitive-prefrailty

A combination of prefrailty stage using Fried criteria and subjective cognitive impairment (SCI). The IANA/IAGG consensus defines cognitive frailty as CDR = 0.5 and frailty by the Fried criteria. In this study, an individual will be considered a CHI if they meet the following criteria: no history of dementia, no use of anti-dementia drugs, normal cognitive performance on cognitive tests and normal scores of ADL and IADL scales. Different participant subgroups will be identified: 1) Individuals will be classified as MCI if they meet the following criteria: Objective cognitive impairment (i.e., performance between 1.5 and 1.9 SDs below the age-appropriate mean) in one or two cognitive domains (i.e., episodic memory and/or executive function) and normal scores of ADL and IADL scales; 2) Individuals will be considered older adults with mild-stage major neurocognitive disorders

Other: Data collection

Individuals with MCR

The diagnosis of MCR syndrome will be made following the criteria of Verghese et al. 5: a combination of subjective cognitive complaint, in particular of memory complaint, with the presence of an objective slow gait and the absence of dementia or mobility disability. MCR syndrome will be defined at baseline assessment and each year of follow-up period. Slow gait speed will be defined as gait speed that is one standard deviation (SD) or more below age-and sex-appropriate mean values established in the present cohort like in previous studies. The mean value and SD of female and male will be determined separately. Gait speed was determined from the 3-meter walking test using the best time of the two trials recorded and expressed as meters per second. Memory complaint used to define MCR syndrome was based on standardized memory loss question on the 15-item Geriatric Depression Scale (GDS; "Do you feel you have more problems with memory than most?").

Other: Data collection

Interventions

Data collection OTHER

Telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site

Individuals with MCR; Individuals with cognitive-prefrailty; Individuals with prefrailty

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals eligible for this study will be the participants of the CLSA

You may qualify if:

• participants of the CLSA with baseline assessment (tracking and comprehensive assessment) and first 18-month follow-up assessment
• age \> 50

You may not qualify if:

• no information which may directly or indirectly determine the occurrence of incident adverse health events (falls and related injuries, depression, functional decline, motoric cognitive risk syndrome, cognitive decline and dementia)
• age \< 50 and demented LCSA participants if they meet the following criteria:
• History of dementia or Alzheimer's disease and/or use of anti-dementia drugs (i.e., Donepezil, Rivastigmine, Galentamine, regardless the dose taken)
• Objective cognitive impairment (i.e., performance ≥2 SDs below the age-appropriate mean) in two cognitive domains (i.e., episodic memory and executive function) and abnormal scores on the ADL and IADL scales

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Frailty

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor of Geriatrics

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: February 19, 2020
• Study Start: December 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

CA (1)