Elderly, FrailNCT04003779
Reconfiguring the Patient Room to Increase Patient Stability
A study testing Room configuration in people with Elderly, Frail and Accidental Falls, run by University of Utah at 1 site in United States.
Trial summary
Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly, Frail, Accidental Falls, Hospitals
- What is being tested?
- Room configuration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 29 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Frail elderly, impaired gait
Who cannot join
- Use of walking aid
Trial locations and contacts
1 site in 1 country.
United States1 site
Dumke Health Professions Building
Salt Lake City, Utah, 84108
About this study
Official title: Reconfiguring the Patient Room for a Fall Protection Strategy to Increase Patient Stability During Ambulation
Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.
Read the detailed description
Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.
An innovative simulation environment will be built to enable rapid assessment of room layout and fixture positioning and patient stability. The results from multiple simulations will be used to fabricate a prototype room layout that will be tested by patients with Parkinson disease and reviewed and updated with input from other relevant stakeholders. A final room prototype will be built and tested. Results will be translated and shared with all stakeholders and disseminated for implementation.
- Conditions
- Elderly, Frail, Accidental Falls, Hospitals
- Being tested
- Room configuration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Room configurationOther
Adjust distance, handrails, degrees of turn for participant
| Study group | Role | What they receive |
|---|---|---|
| Participant stability with various room configurations | Other | Single-arm. Ergonomically exploring patient stability moving around various configurations of a hospital room. Receives: Other: Room configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait: increased stability
Increased balance
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start14 Jul 2022
- Primary completion29 Sep 2024
- Study completion29 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly, FrailStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Using virtual reality and ergonomic measures, we will sequentially adjust features of the hospital room to determine the most stable gate in frail elderly patients.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- The Center for Health Design
- Responsible party
- Principal investigator, Bob Wong, University of Utah
- Investigators
- Bob G Wong, PhD, Principal investigator, University of UtahAndrew Merryweather, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003779
- Sponsor's protocol ID
- 00099410
- Status last verified
- Mar 2025
- First submitted
- 25 Jun 2019
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconfiguring the Patient Room for a Fall Protection Strategy to Increase Patient Stability During Ambulation
- ClinicalTrials.gov ID
- NCT04003779
- Acronym / sponsor ID
- 00099410
- Conditions
- Elderly, Frail, Accidental Falls, Hospitals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- The Center for Health Design
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 29 Sep 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.
Detailed description
Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.
An innovative simulation environment will be built to enable rapid assessment of room layout and fixture positioning and patient stability. The results from multiple simulations will be used to fabricate a prototype room layout that will be tested by patients with Parkinson disease and reviewed and updated with input from other relevant stakeholders. A final room prototype will be built and tested. Results will be translated and shared with all stakeholders and disseminated for implementation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Using virtual reality and ergonomic measures, we will sequentially adjust features of the hospital room to determine the most stable gate in frail elderly patients.
| Arm | Type | Receives |
|---|---|---|
| Participant stability with various room configurations | Other | Other: Room configurationSingle-arm. Ergonomically exploring patient stability moving around various configurations of a hospital room. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Frail elderly, impaired gait
Key exclusion criteria (1 listed)
- Use of walking aid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Room configurationAdjust distance, handrails, degrees of turn for participant | Other | Participant stability with various room configurations |
Primary outcome
Gait: increased stability
Time frame: 24 months
Increased balance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bob G Wong, PhD principal investigator
University of Utah
Andrew Merryweather, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Room configuration in people with Elderly, Frail and Accidental Falls, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait: increased stability (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.