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Standing Balance as the Fifth Vital Sign in Clinical Setting

NCT04139642 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2023-10-25

Study results available
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Summary

This 18-month prospective, observational study involving real world data will determine if the use of a standing scale that delivers a quantitative measure of standing balance along with weight (balance + weight) in place of a scale that only delivers weight (weight only) influences clinical decision making by health care practitioners in the ambulatory outpatient setting. Providers will be randomized to receive the balance+weight scale or weight-only scale for 9 months, then to crossover and receive the other for 9 months. The primary outcome measures are (1) providers' self-reported perceptions of whether the balance measurement influences their clinical decision making and (2) the rate of performing falls risk assessments or referring to a specialist for evaluation and treatment based on aggregate billing data. The secondary outcome measure is qualitative interviews with practitioners regarding their perceptions on the utility and barriers to using the device.

Conditions

  • Accidental Fall
  • Postural Balance
  • Clinical Decision-making

Interventions

DEVICE

SimpleSway

During the 9-month period each practitioner who receives the balance + weight device is asked to provide anonymous feedback via a kiosk regarding if the balance data influenced clinical decision making after every patient. The kiosk has four marked buttons indicating a 4-point Likert Scale, so the practitioner just presses one of the four buttons to indicate their agreement with the statement, "The balance measurement influenced my clinical decision making with this patient." After 9 months, the devices are switched so that every practitioner who had a weight only device receives balance + weight device and vice versa. After the second 9-month period concludes all devices will be retrieved by study personnel, and participants will be asked to complete surveys regarding their experience and attend group feedback sessions regarding their experiences.

Sponsors & Collaborators

  • Bertec Corporation

    collaborator INDUSTRY

  • National Institute on Aging (NIA)

    collaborator NIH

  • Ohio State University

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2022-04-30
Completion
2022-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04139642 on ClinicalTrials.gov