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CatchU: A Quantitative Multisensory Falls-Assessment Study (CatchU)

Primary Purpose

Fall Injury, Age Problem, Well Aging

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CatchU Intervention
Sponsored by
Jeannette Mahoney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fall Injury focused on measuring falls, aging, multisensory integration

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

General inclusion criteria:

  1. Adults aged 65 and older, residing in New York Metropolitan area who plan to be in area for next three or more years.
  2. Able to speak English at a level sufficient to undergo our assessment battery.
  3. Ambulatory. Participants are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit. These include participants who are bed-bound as a result of severe medical illness or those who require assistive medical devices (respiratory support or ventilators) that cannot be transported or those who cannot complete our mobility protocols. We will not exclude participants who use walking aids (canes, crutches) for ambulation. Participants who require walking aids to walk outside but are able to complete our mobility protocols without an assistive device or the assistance of another person will not be excluded.

General exclusion criteria (one or more criteria):

  1. Presence of dementia as defined as a score of ≥ 2 on the Alzheimer's Disease 8 (AD8) or < 25 on The Montreal Cognitive Assessment (MoCA). These cut scores and procedures have been validated in our and other aging studies.
  2. Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease. Individuals with recent cardiovascular or cerebrovascular event (Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass Graft, or stroke) will not be excluded if they meet above inclusion criteria. Many of these chronic conditions are very common in older adults. Hence, mere presence of these conditions will not be used to exclude participants if well controlled or of mild severity and if participants are able to complete training and mobility tasks.
  3. Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent participants from completing mobility tests.
  4. Any medical condition or chronic medication use (e.g., neuroleptics) in the judgment of the screening clinician that will compromise safety or affect cognitive functioning or terminal illness with life expectancy less than 12 months.
  5. Progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS) diagnosed by study clinician or as per medical history.
  6. Presence of clinical disorders that overtly alter attention like delirium.
  7. Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g., hip or knee replacement) and that prevent participants from completing mobility tests or plans for surgery affecting mobility in the next 6 months.
  8. Severe auditory, visual, or somatosensory self-reported impairments. Visual acuity will be screened using a Snellen chart by the psychological assistant. Presence of neuropathy will be assessed using the Michigan Neuropathy Screening Instrument.
  9. Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols. Past history of these symptoms or presence of psychiatric illness not used as exclusion criteria.
  10. Living in nursing home.
  11. Participation in another intervention trial. Participants can participate in other observational studies.

Sites / Locations

  • Albert Einstein College of Medicine/Montefiore Medical Center
  • Burke Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

CatchU Intervention

Arm Description

Placement into the intervention vs. control group is random, but dependent upon multisensory integration performance. Meaning, older adults who are enrolled and screened with good integration abilities on the CatchU test (aka: VSI + (good) integrators), (VSI = visual-somatosensory integration) will not be placed in either the intervention or control group since better visual-somatosensory integration performance has been linked to better cognitive and motor outcomes. These participants will be included in examination of additional study aims not related to the intervention. VSI - (poor) integrators, will be randomly assigned into either the intervention or control group to test the beneficial effect of the CatchU intervention. Participants in the Control arm will be monitored every two months via telephone surveys to determine falls history, but will not receive the CatchU intervention.

Placement into the intervention vs. control group is random, but dependent upon multisensory integration performance. VSI - (poor) integrators, will be randomly assigned into either the intervention or control group to test the beneficial effect of the CatchU intervention. Participants in the Intervention arm will be monitored every two months to determine falls history, but will also receive the CatchU intervention which consists of physicians relaying individualized recommendations from the CatchU physician report to the participant, as well as providing the participant with falls intervention referrals and falls counseling.

Outcomes

Primary Outcome Measures

Falls
Information about falls (answers to questions regarding whether the participant has had a fall in the past 1 year or past 2 months after study enrollment) will be collected. If a fall is endorsed during the interview, further information regarding when and where the fall occurred and whether it led to a major injury or hospitalization will also be collected. The relationship of multisensory integration performance on CatchU with history of falls in the past year (baseline) and incident falls over a 24-month period post-baseline visit (collected bimonthly through telephone interviews) will be assessed using Cox proportional hazard models. Here we will look at fall presence (yes or no) and time to fall (or censor if no fall) relative to baseline enrollment date

Secondary Outcome Measures

Full Information

First Posted
September 14, 2022
Last Updated
June 15, 2023
Sponsor
Jeannette Mahoney
Collaborators
Burke Rehabilitation Hospital, Albert Einstein College of Medicine, Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05544760
Brief Title
CatchU: A Quantitative Multisensory Falls-Assessment Study
Acronym
CatchU
Official Title
CatchU: A Quantitative Multisensory Falls-Assessment Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeannette Mahoney
Collaborators
Burke Rehabilitation Hospital, Albert Einstein College of Medicine, Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The ability to successfully integrate information across sensory systems is a vital aspect of functioning in the real world. To date, only a few studies have investigated the clinical translational value of multisensory integration processes. Previous work has linked the magnitude of visual-somatosensory integration (measured behaviorally using simple reaction time tasks) to important cognitive (attention) and motor (balance, gait, and falls) outcomes in healthy older adults. While multisensory integration effects have been measured across a wide array of populations using various sensory combinations and different neuroscience approaches, a gold standard for quantifying multisensory integration has been lacking. The investigator recently developed a step-by-step protocol for administering and calculating multisensory integration effects in an effort to facilitate innovative and novel translational research across diverse clinical populations and age-ranges. However, patients with severe medical conditions and/or mobility limitations often experience difficulty traveling to research facilities or joining time-demanding research protocols. Using the aforementioned protocol, the study team invented a mobile multisensory falls-assessment iPhone app called CatchU to facilitate physician discussion and counseling of falls in older adults during clinical visits (e.g., annual wellness visits with a subsequent telehealth call), in an attempt to alleviate disability, promote independence, and increase quality of life for older adults. The investigator team has provided a cross-sectional research proposal for a pilot study of 300 patients (over a 24-month period) in order to demonstrate acceptable-to-excellent predicative accuracy of CatchU for identifying older adults at-risk for falls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall Injury, Age Problem, Well Aging, Sensory Disorders
Keywords
falls, aging, multisensory integration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This randomized clinical trial, first examines whether participants are good or bad multisensory integrators. If eligible and interested in participating, we will screen 300 participants level of multisensory integration. If participants are good integrators, no randomization will be necessary as these participants will not meet inclusion trial for the intervention trial. If participants are poor integrators, then they will be randomized into either the control (regular care) or intervention (CDC recommendations and falls counseling) arms. Note that be expect ~134 participants to be poor integrators. Those that are good integrators will not be included in the intervention trial but will be included in the larger observational study to test other study aims including 1) demonstrating acceptable concurrent validity of CatchU for identifying older adults' multisensory integration performance in older adults and 2) Examining predictive validity of CatchU in older adults.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Placement into the intervention vs. control group is random, but dependent upon multisensory integration performance. Meaning, older adults who are enrolled and screened with good integration abilities on the CatchU test (aka: VSI + (good) integrators), (VSI = visual-somatosensory integration) will not be placed in either the intervention or control group since better visual-somatosensory integration performance has been linked to better cognitive and motor outcomes. These participants will be included in examination of additional study aims not related to the intervention. VSI - (poor) integrators, will be randomly assigned into either the intervention or control group to test the beneficial effect of the CatchU intervention. Participants in the Control arm will be monitored every two months via telephone surveys to determine falls history, but will not receive the CatchU intervention.
Arm Title
CatchU Intervention
Arm Type
Experimental
Arm Description
Placement into the intervention vs. control group is random, but dependent upon multisensory integration performance. VSI - (poor) integrators, will be randomly assigned into either the intervention or control group to test the beneficial effect of the CatchU intervention. Participants in the Intervention arm will be monitored every two months to determine falls history, but will also receive the CatchU intervention which consists of physicians relaying individualized recommendations from the CatchU physician report to the participant, as well as providing the participant with falls intervention referrals and falls counseling.
Intervention Type
Other
Intervention Name(s)
CatchU Intervention
Intervention Description
The CatchU Intervention arm will receive individualized recommendations (adapted from the CDC STEADI program) as outlined on the CatchU physician report sent to the participants physicians. These recommendations in combination with falls intervention referrals and falls counseling tips will be monitored and statistical investigation of the impact of CatchU intervention in preventing future falls will be determined.
Primary Outcome Measure Information:
Title
Falls
Description
Information about falls (answers to questions regarding whether the participant has had a fall in the past 1 year or past 2 months after study enrollment) will be collected. If a fall is endorsed during the interview, further information regarding when and where the fall occurred and whether it led to a major injury or hospitalization will also be collected. The relationship of multisensory integration performance on CatchU with history of falls in the past year (baseline) and incident falls over a 24-month period post-baseline visit (collected bimonthly through telephone interviews) will be assessed using Cox proportional hazard models. Here we will look at fall presence (yes or no) and time to fall (or censor if no fall) relative to baseline enrollment date
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
General inclusion criteria: Adults aged 65 and older, residing in New York Metropolitan area who plan to be in area for next three or more years. Able to speak English at a level sufficient to undergo our assessment battery. Ambulatory. Participants are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit. These include participants who are bed-bound as a result of severe medical illness or those who require assistive medical devices (respiratory support or ventilators) that cannot be transported or those who cannot complete our mobility protocols. We will not exclude participants who use walking aids (canes, crutches) for ambulation. Participants who require walking aids to walk outside but are able to complete our mobility protocols without an assistive device or the assistance of another person will not be excluded. General exclusion criteria (one or more criteria): Presence of dementia as defined as a score of ≥ 2 on the Alzheimer's Disease 8 (AD8) or < 25 on The Montreal Cognitive Assessment (MoCA). These cut scores and procedures have been validated in our and other aging studies. Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease. Individuals with recent cardiovascular or cerebrovascular event (Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass Graft, or stroke) will not be excluded if they meet above inclusion criteria. Many of these chronic conditions are very common in older adults. Hence, mere presence of these conditions will not be used to exclude participants if well controlled or of mild severity and if participants are able to complete training and mobility tasks. Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent participants from completing mobility tests. Any medical condition or chronic medication use (e.g., neuroleptics) in the judgment of the screening clinician that will compromise safety or affect cognitive functioning or terminal illness with life expectancy less than 12 months. Progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS) diagnosed by study clinician or as per medical history. Presence of clinical disorders that overtly alter attention like delirium. Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g., hip or knee replacement) and that prevent participants from completing mobility tests or plans for surgery affecting mobility in the next 6 months. Severe auditory, visual, or somatosensory self-reported impairments. Visual acuity will be screened using a Snellen chart by the psychological assistant. Presence of neuropathy will be assessed using the Michigan Neuropathy Screening Instrument. Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols. Past history of these symptoms or presence of psychiatric illness not used as exclusion criteria. Living in nursing home. Participation in another intervention trial. Participants can participate in other observational studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeannette R Mahoney, PhD
Phone
18457212086
Email
jeannette.mahoney@einsteinmed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mooyeon Oh-Park, MD
Phone
19145972514
Email
MOhPark@burke.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannette R Mahoney, PhD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine/Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeannette R Mahoney, PhD
Phone
845-721-2086
Email
jeannette.mahoney@einsteinmed.edu
Facility Name
Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mooyeon Oh-Park, MD
Phone
914-597-2514
Email
MOhPark@burke.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De identified participant data will be shared
IPD Sharing Time Frame
De-identified study data will be available forever
Links:
URL
http://catchu.net
Description
Catchu Website

Learn more about this trial

CatchU: A Quantitative Multisensory Falls-Assessment Study

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