NCT04675307

Brief Summary

The investigators seek to construct a novel, multimodal, distributed system that facilitates a new paradigm of home-based medical surveillance and treatment for frail older adults centered on timely diagnosis of movement system impairments and personalized intervention. Measurements from a heterogeneous set of complementary sensors will be combined with clinically-informed and data-learned dynamic models of human motion to enable real-time activity recognition (e.g., sitting, standing, walking) and movement assessments (e.g., speed, repetition, quality). As the study progresses, the system will be integrated with wearable assistive technology to provide "smart", activity-specific assistance of movement deficits or the activation of caregivers if a decline in function is detected. Finally, the investigators will test the combined assessment and intervention system in the clinic and the home, identifying challenges and solutions for the scaling up to unconstrained real-world settings.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2023

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

December 8, 2020

Last Update Submit

March 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Video and inertial motion unit capture

    Successfully capture video and inertial motion unit capture of subjects as they perform various movement assessments.

    1 recording episode, approximately 3 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will consist of frail adults and frail older adults. Frailty is defined as a state of increased vulnerability and reduced ability to recover after a stressful event, leading to adverse health outcomes.

You may qualify if:

  • Age \>= 18 years
  • Capacity to consent
  • Community dwelling
  • Ability to follow 3-step commands
  • Lives within 15 miles of Boston

You may not qualify if:

  • Undomiciled
  • Active substance use disorder
  • Active psychosis
  • Domestic violence or neglect
  • Inability to communicate with investigators
  • Other comorbidities that prevent full participation in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

David M Levine, MD, MPH, MA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David Levine, MD, MPH, MA- Principle Investigator

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 19, 2020

Study Start

February 17, 2021

Primary Completion

December 1, 2023

Study Completion

December 2, 2023

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations