N/A
N=42
Standing Balance as the Fifth Vital Sign in Clinical Setting
Accidental Fall · Postural Balance · Clinical Decision-making
Bottom Line
View on ClinicalTrials.gov: NCT04139642 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Percentage of Balance-Related Diagnoses — 12118; 11763; 19904 unique visits — p=<0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SimpleSway (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Balance-Related Diagnoses |
12118; 11763; 19904 | <0.0001 sig |
| PRIMARY Number of Unique Visits With and Without Balance-Related Referrals |
474; 479; 1145; 41252; 37757; 68079 | =0.15 |
| PRIMARY Providers' Perceptions Reported as Number of Responses |
117; 347; 115; 455; 47; 226 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Columbus Metropolitan Area by the following counties: Franklin, Madison, Union, Delaware, Locking, Fairfield, Pickaway.
- Physician, advanced practice registered nurse, or physician assistant, who diagnoses and treats patients in ambulatory outpatient settings
- self-report that falls are a concern for a significant fraction of the participant's patients, where the participants defines significant as they see fit.
- Participants must commit to using the test device as the primary weight scale in the clinic for the duration of the study to be selected.
Exclusion Criteria
- No gender, ethnic, or racial groups will be excluded from this study, though it is expected that the majority of the sample will be Caucasian American, given that the professions of physicians, nurse practitioners, and physician assistants are predominantly Caucasian American.
Data sourced from ClinicalTrials.gov (NCT04139642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.