At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Standing Balance as the Fifth Vital Sign in Clinical Setting
In Brief
An observational study evaluating SimpleSway for Accidental Fall and 2 related conditions. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.