FrailtyNCT05754021
A Practical Platform for In-Home Remote Monitoring of Cognitive Frailty
An observational study of Frailty and Cognitive Impairment, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Frailty, Cognitive Impairment, Dementia
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- All sexes
- Adult, Older adult
Study population: Ambulatory older adults (over 50 years old) willing to participate
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-CF: A Practical Platform for 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.
Read the detailed description
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.
- 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
- Medical subject headings
- Frailty, Cognitive Dysfunction, Dementia, Alzheimer Disease, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline, every 2 months, up to 12 months
Secondary outcomes (4)
Change in Physical activity from baseline to 6 months and 12 months
Assessed by a validated wearable device called PAMSys (Biosensics LLC, MA, USA). We will use daily number of steps to determine physical activities.
Measured: baseline, 6 month, 12 month
Change in Gait speed from baseline to 6 months and 12 months
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)
Measured: baseline, 6 month, 12 month
Change in Balance from baseline to 6 months and 12 months
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
Measured: baseline, 6 month, 12 month
Change in physical frailty from baseline to 6 months and 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.
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Feb 2022
- Primary completion31 Aug 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- BioSensics
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754021
- Sponsor's protocol ID
- 43917
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33777594Wang 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.
PubMed 36642072
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-CF: A Practical Platform for Remote Monitoring of Cognitive Frailty
- ClinicalTrials.gov ID
- NCT05754021
- Acronym / sponsor ID
- 43917
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- BioSensics
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Ambulatory older adults (over 50 years old) willing to participate
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
4 secondary outcomes
Change in Physical activity from baseline to 6 months and 12 months
Time frame: baseline, 6 month, 12 month
Change in Gait speed 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
Time frame: baseline, 6 month, 12 month
Change in physical frailty from baseline to 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Background: PubMed 33777594Zahiri 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.
- Results publication: PubMed 36642072Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Cognitive Impairment, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function from baseline to 6 months and 12 months (time frame: baseline, every 2 months, up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05754021, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.