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

February 12, 2025 updated by: Bijan Najafi, PhD, Baylor College of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Bijan Najafi, PhD
  • Phone Number: 713-798-7536
  • Email: najafi@bcm.edu

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, every 2 months, up to 12 months
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
baseline, every 2 months, up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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 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)
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 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
baseline, 6 month, 12 month
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.
baseline, 6 months, 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
baseline, 6 month, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor College of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BioSensics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 43917

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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