Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2022-03-28
2022-09-07
Brief Summary
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Detailed Description
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The proposed study will consist of an initial intake visit on Day 1, followed by an at-home (i.e. LTC facility, nursing home, and/or assisted living facility) phase where the participant will wear two watch like devices one on each wrist and answer two questions on paper each day. There will be a second visit on day 8 where the participant will complete additional questionnaires and assessments. The participant will continue wearing the wrist-worn devices for days 9-14, with a final visit on day 15 for final assessments and device collection. A window of +/- 3 days will be allocated for the scheduling of all visits to accommodate participant's schedules and commitments. Activities will take place in the care facility where the participant resides, or the Laboratory for Human Neurobiology for those that will commute. The study procedures will be identical for all participants for all Frailty groups.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fried Frailty Phenotype 0
Those who are considered Robust under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement and body weight composition in healthy adults.
Wrist Actigraphy Device
a watch like wearable sensor
Smart Body Weight Scale
a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Chair Scale
a wheel-chair compatible scale to measure body weight
Handheld Body Fat Percentage Device
a handheld device that measures body fat percentage
Bioelectric Impedance Analysis Scale
a research-grade full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Fried Frailty Phenotype 1-2
Those who are considered Intermediate/Pre-frail under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement and body weight composition in healthy adults.
Wrist Actigraphy Device
a watch like wearable sensor
Smart Body Weight Scale
a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Chair Scale
a wheel-chair compatible scale to measure body weight
Handheld Body Fat Percentage Device
a handheld device that measures body fat percentage
Bioelectric Impedance Analysis Scale
a research-grade full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Fried Frailty Phenotype 3+
Those who are considered Frail under the Fried Frailty Criteria. Sensor technology and digital measures will be used to evaluate movement and body weight composition in healthy adults.
Wrist Actigraphy Device
a watch like wearable sensor
Smart Body Weight Scale
a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Chair Scale
a wheel-chair compatible scale to measure body weight
Handheld Body Fat Percentage Device
a handheld device that measures body fat percentage
Bioelectric Impedance Analysis Scale
a research-grade full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Interventions
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Wrist Actigraphy Device
a watch like wearable sensor
Smart Body Weight Scale
a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Chair Scale
a wheel-chair compatible scale to measure body weight
Handheld Body Fat Percentage Device
a handheld device that measures body fat percentage
Bioelectric Impedance Analysis Scale
a research-grade full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends (conducted based on participant's abilities)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No recent hospitalizations/acute events in last 30 days
3. No active or recent (within 12 months) cancer diagnosis except skin cancer \[limited to only non-complicated squamous and basal cell skin cancer (SCC/BCC)\]
4. Body mass index (BMI) \< 30 kg/m2
5. Able to understand and cooperate with study procedures and able to read, understand and provide informed consent. Evidence of a personally signed and dated informed consent document indicating that the participant, if necessary, their legally authorized representative (LAR) has been informed of all pertinent aspects of the study.
6. Native English speakers or demonstrated fluency in English as determined by the Investigator
7. WRAT-4 Word Reading Subtest equivalent to 8th grade reading level or greater
8. Montreal Cognitive Assessment (MoCA) score of ≥ to 19
Exclusion Criteria
2. Moderate to severe alcohol use disorder diagnosis within 6 months of the screening as disclosed by the subject
3. Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Boston University/Boston Medical Center (BU/BMC) employees directly involved in the conduct of the study
4. Inability to comply with study requirements
5. Life expectancy of less than 6 months, or actively enrolled in a palliative care program
6. Has any clinically significant medical disorder, condition, disease, or clinically significant finding at screening that precludes subject's participation in study activities
7. Participants with electronic implant such as pacemaker etc., due to Bioelectric Impedance Analysis (BIA) body composition devices (Tanita, Smart body scale) using tiny electrical signal for measurements
8. At an increased risk of COVID-19 as determined by the Laboratory for Human Neurobiology COVID-19 Human Subject Risk Assessment Survey
9. Temperature equal to or above 100.4 degrees F
10. Modified Barthel Index of \<40
65 Years
ALL
Yes
Sponsors
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Boston University
OTHER
Responsible Party
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Principal Investigators
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Kevin C Thomas, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator, Boston University, Department of Anatomy & Neurobiology
Locations
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Evans Biomedical Research Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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H-42048
Identifier Type: -
Identifier Source: org_study_id
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