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

NCT05754021 | Completed

• 1 other identifier: 43917
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty; Cognitive Impairment; Dementia; Cognitive Impairment, Mild; Alzheimer Disease; Alzheimer Disease, Early Onset

Keywords

frailty; remote patient monitoring; mild cognitive impairement; early diagnosis; Telemedicine

Outcome Measures

Primary Outcomes (2)

• Change in cognitive function from baseline to 6 months and 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.

  baseline, every 2 months, up to 12 months

• Change in cognitive frailty performance every other month from baseline 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

  baseline, every 2 months, up to 12 months

Secondary Outcomes (4)

• Change in Physical activity from baseline to 6 months and 12 months

  baseline, 6 month, 12 month

• Change in Gait speed from baseline to 6 months and 12 months

  baseline, 6 month, 12 month

• Change in Balance from baseline to 6 months and 12 months

  baseline, 6 month, 12 month

• Change in physical frailty from baseline to 6 months and 12 months

  baseline, 6 months, 12 months

Other Outcomes (1)

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

  baseline, 6 month, 12 month

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ambulatory older adults (over 50 years old) willing to participate

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• BioSensics: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Zahiri M, Wang C, Gardea M, Nguyen H, Shahbazi M, Sharafkhaneh A, Ruiz IT, Nguyen CK, Bryant MS, Najafi B. Remote Physical Frailty Monitoring-The Application of Deep Learning-Based Image Processing in Tele-Health. IEEE Access. 2020;8:219391-219399. doi: 10.1109/access.2020.3042451. Epub 2020 Dec 4.

  PMID: 33777594 BACKGROUND

• Wang C, Zahiri M, Vaziri A, Najafi B. Dual-Task Upper Extremity Motor Performance Measured by Video Processing as Cognitive-Motor Markers for Older Adults. Gerontology. 2023;69(5):650-656. doi: 10.1159/000528853. Epub 2023 Jan 13.

  PMID: 36642072 RESULT

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction; Dementia; Alzheimer Disease; Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Design

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

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 3, 2023
• Study Start: February 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: January 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)