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Completed

NCT Number: NCT05754021

A Practical Platform for In-Home Remote Monitoring of Cognitive Frailty

Cognitive frailty, characterized by the coexistence of physical frailty and cognitive impairment, is a robust indicator of cognitive decline. Recognizing its significance, the International Association of Gerontology and Geriatrics and the International Academy on Nutrition and Aging have advocated for the use of cognitive frailty assessment as a means of monitoring the progression of mild cognitive impairment towards debilitating conditions like dementia, Alzheimer's disease, and loss of independence. Despite the clear need, a practical and remotely accessible tool for measuring cognitive frailty is currently lacking, especially within the context of telehealth visits. With telehealth video-conferencing becoming increasingly popular, accepted by healthcare payers, and preferred by older adults who may face difficulties traveling to a clinic, there is a pressing need for a software-based solution for remote cognitive frailty assessment that can be easily integrated into existing telehealth systems. This study proposes designing and validating a video-based solution to remotely monitor cognitive-frailty in older adults.

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Key information

Conditions

Frailty Alzheimer Disease Alzheimer Disease, Early Onset Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Cognitive Impairment, Mild Dementia Disease Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tauopathies

Age range

50 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

The investigators are proposing to evaluate the feasibility and accuracy of the Frailty Meter (FM), a cutting-edge video-based solution for remotely assessing frailty. FM determines frailty phenotypes, such as weakness, slowness, reduced range-of-motion, and exhaustion, by quantifying the results of a 20-second rapid repetitive elbow flexion-extension task captured by a standard video camera. Image processing algorithms are then used to estimate the angular velocity of the elbow, and a previously validated model is employed to calculate frailty phenotypes from the speed of elbow rotation. Furthermore, FM can also be used to assess cognitive impairment when applied during dual-task conditions, such as while performing a working memory task. The objective of this study is to validate the effectiveness of this video-based solution in tracking longitudinal changes in cognitive-motor function among older adults.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50 years or older
  • Ambulatory
  • Able and willing to provide consent
  • May have a diagnosis of mild dementia or pre-dementia or mild cognitive impairment (MCI), or MoCA score of 26 or lower.

Exclusion criteria

  • Major bilateral upper-limb disorder
  • Major hearing/visual impairment
  • History of stroke in the last 90 days
  • Receiving hospice care
  • Immobility or major mobility disorder: We will exclude those who were bedbound or unable to stand or ambulate with or without walking assistance
  • inability to use telemedicine (e.g. no internet at home, severe visual or hearing problem, lack of caregiver support, etc)
  • inability or unwillingness to participate in bi-monthly tele-medicine assessments or in-clinic visit (e.g., living farther than 30 mills from the clinic, unavailability of caregivers).
  • significant cognitive impairment (MoCA score<16)
  • severe dementia
  • severe apathy
  • severe depression
  • in hospice care or palliative care
  • history of drug or alcohol abuse over the last six months
  • unable to communicate in English or Spanish

Treatment and study plan

Primary outcomes

  1. Change in cognitive function from baseline to 6 months and 12 months

    Time frame: baseline, every 2 months, up to 12 months

    Cognitive performance will be assessed using Montreal Cognitive Assessment (MoCA). Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.

  2. Change in cognitive frailty performance every other month from baseline to 12 months

    Time frame: baseline, every 2 months, up to 12 months

    Frailty will be evaluated using the Frailty Meter, which will calculate a frailty score based on four frailty phenotypes collected during an upper extremity test that includes a cognitive task of counting backwards. The phenotypes include slowness, exhaustion, weakness, rigidity, and dual-task cost. The cognitive frailty score, which ranges from 0 to 1, indicates the severity of cognitive-frailty with higher values signifying a more advanced stage of frailty

Secondary outcomes

  1. Change in Physical activity from baseline to 6 months and 12 months

    Time frame: baseline, 6 month, 12 month

    Assessed by a validated wearable device called PAMSys (Biosensics LLC, MA, USA). We will use daily number of steps to determine physical activities.

  2. Change in Gait speed from baseline to 6 months and 12 months

    Time frame: baseline, 6 month, 12 month

    Change from baseline in Gait speed at 6 months and 12 months. Gait speed will be measured using a validated wearable platform (LEGSys) during habitual walking speed. The unit is meter per second (m/s)

  3. Change in Balance from baseline to 6 months and 12 months

    Time frame: baseline, 6 month, 12 month

    Change in balance from baseline to 6 months and 12 months will be measured. Balance will be assessed by measuring center of mass sway. The investigator will use a validated wearable platform (BalanSens) to measure body sway. The unit is cm/s2

  4. Change in physical frailty from baseline to 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    The Fried Frailty Questionnaire will be administered to assess frailty based on five phenotypes: slowness, exhaustion, weakness, inactivity, and weight loss. Participants will be classified as robust, pre-frail, or frail based on the presence or absence of each phenotype.

Other outcomes

  1. Acceptability of tele-cognitive frailty protocol from baseline to 6 months and 12 months

    Time frame: baseline, 6 month, 12 month

    Acceptability will be assessed using Technology Acceptance Model questionnaire (TAM) adopted for telehealth applications. Likert scale is used to quantify perceived benefit, perceived ease of use, and attitude toward use. The scale is ranged from 0 (strongly disagree) to 7 (strongly agree).

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • BioSensics

Registry information

Official study title

Tele-CF: A Practical Platform for Remote Monitoring of Cognitive Frailty

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 3, 2023
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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