FallsNCT07126925
A Trial of an Improved Fall Risk Assessment and Activity Test to Prevent Falls in Elderly Inpatients
A study testing Personalized Fall Prevention Program and Standard Fall Prevention Care in people with Falls, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This randomized controlled trial was conducted to evaluate if a personalized fall prevention strategy could reduce fall incidence in elderly hospitalized patients. A total of 320 patients were randomized into two groups. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Falls
- What is being tested?
- Personalized Fall Prevention Program and Standard Fall Prevention Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Inpatients aged 65 and above.
- Identified as being at risk of falling upon admission screening (defined as having at least one of the following: history of a fall in the last 6 months, use of a walking aid, or observed gait/balance instability).
- Able to provide informed consent or have a legal guardian provide consent.
Who cannot join
- Acutely life-threatening conditions or severe cardiorespiratory instability that would preclude any mobility testing.
- History of a severe fall-related injury (defined as a fracture or head injury requiring hospitalization) in the past 6 months that currently limits mobility assessment.
- Non-ambulatory or bed-bound patients.
- Patients with severe dementia (e.g., Mini-Mental State Examination score < 10) or diagnosed psychiatric conditions (e.g., psychosis, severe agitation) that would prevent cooperation.
- Expected hospital stay of less than 48 hours.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
About this study
Official title: Effectiveness of an Improved Fall Risk Assessment Form Combined With Obstacle Physical Activity Testing in Preventing Falls in Elderly Hospitalized Patients
This randomized controlled trial was conducted to evaluate if a personalized fall prevention strategy could reduce fall incidence in elderly hospitalized patients. A total of 320 patients were randomized into two groups. The experimental group received interventions guided by an improved fall risk assessment form and an obstacle physical activity test. The control group received standard hospital care. The primary outcome was the incidence of falls. Secondary outcomes included injury severity, nursing satisfaction, patient compliance, and quality of life.
Read the detailed description
Falls are a common and serious adverse event among elderly hospitalized patients. While standard risk assessment tools exist, they often fail to capture dynamic risk factors related to patient mobility and environmental interaction. This study aimed to determine if a comprehensive assessment approach could improve fall prevention outcomes. This was a single-center, randomized controlled trial. A total of 320 inpatients aged 65 and older were randomly assigned to either an experimental group or a control group. The experimental group was assessed using an "Improved Risk Assessment Form for Inpatient Falls" and a novel "Obstacle Physical Activity Ability Test." The results guided a personalized fall prevention plan, including targeted exercises and environmental modifications. The control group received the hospital's standard fall prevention care, which included a standard risk checklist and universal precautions. The study's main objective was to compare the incidence of falls between the two groups throughout their hospital stay. Other outcomes, such as injury severity, patient satisfaction, compliance with preventive measures, and quality of life, were also assessed to evaluate the broader impact of the intervention.
- Conditions
- Falls
- Being tested
- Personalized Fall Prevention Program, Standard Fall Prevention Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Fall Prevention ProgramBehavioural
An intervention package featuring a comprehensive, multidimensional risk assessment using an improved form and a dynamic functional test (Obstacle Physical Activity Ability Test). The assessment guided the development of a personalized prevention plan, including targeted exercises, environmental adjustments, and enhanced patient/family education.
Standard Fall Prevention CareBehavioural
Standard hospital care for fall prevention, including universal precautions (e.g., clutter-free environment, non-slip footwear) and risk assessment using a standard hospital checklist.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Personalized Fall Prevention Group | Experimental | Patients in this group received universal fall precautions plus a comprehensive assessment using the "Improved Risk Assessment Form for Inpatient Falls" and the "Obstacle Physical Activity Ability Test." Based on the assessment results, a personalized fall prevention plan was developed and implemented by the nursing and physical therapy team. Receives: Behavioral: Personalized Fall Prevention Program |
| Active Comparator: Standard Care Group | Active comparator | Patients in this group received the hospital's standard of care for fall prevention. This included universal fall precautions and a standard risk assessment using the hospital's existing protocol based on static factors. Interventions were standard and not explicitly tailored to individual functional deficits. Receives: Behavioral: Standard Fall Prevention Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Incidence
The proportion of patients experiencing one or more falls. A fall was defined as an event which results in a person coming to rest inadvertently on the ground or floor or other lower level. It was recorded through the hospital's incident reporting system, patient self-report, and daily nursing checks.
Measured: Through study completion, an average of 10 days
Secondary outcomes (5)
Severity of Fall-Related Injury
Classification of injuries sustained from a fall, categorized by a physician as: no injury, minor injury (e.g., bruises, abrasions), or major injury (e.g., fracture, head injury with loss of consciousness, laceration requiring sutures).
Measured: Through study completion, an average of 10 days
Nursing Satisfaction
Patient-reported satisfaction with nursing communication, responsiveness, and fall prevention education, measured using a 5-item institutional survey on a 10-point scale.
Measured: At discharge (an average of 10 days post-admission)
Patient Compliance
Adherence to prescribed fall prevention precautions, assessed via a 10-item observational checklist of precautions (e.g., using call bell, bed in low position). Compliance was categorized based on the percentage of items adhered to.
Measured: Through study completion, an average of 10 days (assessed weekly)
Change in Physical Activity Ability
Change in physical mobility from admission to discharge, categorized by the treating physical therapist as "Improved markedly," "Improved," "No change," or "Reduced," based on clinical judgment and performance on the obstacle test.
Measured: Baseline and at discharge (an average of 10 days)
Change in Quality of Life (QoL)
Change in QoL from admission to discharge, measured by the mean change in a 10-point global QoL rating from a structured, non-validated questionnaire covering physical, psychological, and social domains. The scale is a 10-point global Quality of Life rating questionnaire, with a range from 1 (worst possible quality of life) to 10 (best possible quality of life). A higher score indicates a better outcome.
Measured: Baseline and at discharge (an average of 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Lu, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126925
- Sponsor's protocol ID
- 2022S0477
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Improved Fall Risk Assessment Form Combined With Obstacle Physical Activity Testing in Preventing Falls in Elderly Hospitalized Patients
- ClinicalTrials.gov ID
- NCT07126925
- Acronym / sponsor ID
- 2022S0477
- Conditions
- Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Aug 2025 (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.
This randomized controlled trial was conducted to evaluate if a personalized fall prevention strategy could reduce fall incidence in elderly hospitalized patients. A total of 320 patients were randomized into two groups. The experimental group received interventions guided by an improved fall risk assessment form and an obstacle physical activity test. The control group received standard hospital care. The primary outcome was the incidence of falls. Secondary outcomes included injury severity, nursing satisfaction, patient compliance, and quality of life.
Detailed description
Falls are a common and serious adverse event among elderly hospitalized patients. While standard risk assessment tools exist, they often fail to capture dynamic risk factors related to patient mobility and environmental interaction. This study aimed to determine if a comprehensive assessment approach could improve fall prevention outcomes. This was a single-center, randomized controlled trial. A total of 320 inpatients aged 65 and older were randomly assigned to either an experimental group or a control group. The experimental group was assessed using an "Improved Risk Assessment Form for Inpatient Falls" and a novel "Obstacle Physical Activity Ability Test." The results guided a personalized fall prevention plan, including targeted exercises and environmental modifications. The control group received the hospital's standard fall prevention care, which included a standard risk checklist and universal precautions. The study's main objective was to compare the incidence of falls between the two groups throughout their hospital stay. Other outcomes, such as injury severity, patient satisfaction, compliance with preventive measures, and quality of life, were also assessed to evaluate the broader impact of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Personalized Fall Prevention Group | Experimental | Behavioral: Personalized Fall Prevention ProgramPatients in this group received universal fall precautions plus a comprehensive assessment using the "Improved Risk Assessment Form for Inpatient Falls" and the "Obstacle Physical Activity Ability Test." Based on the assessment results, a personalized fall prevention plan was developed and implemented by the nursing and physical therapy team. |
| Active Comparator: Standard Care Group | Active comparator | Behavioral: Standard Fall Prevention CarePatients in this group received the hospital's standard of care for fall prevention. This included universal fall precautions and a standard risk assessment using the hospital's existing protocol based on static factors. Interventions were standard and not explicitly tailored to individual functional deficits. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Inpatients aged 65 and above.
- Identified as being at risk of falling upon admission screening (defined as having at least one of the following: history of a fall in the last 6 months, use of a walking aid, or observed gait/balance instability).
- Able to provide informed consent or have a legal guardian provide consent.
Key exclusion criteria (5 listed)
- Acutely life-threatening conditions or severe cardiorespiratory instability that would preclude any mobility testing.
- History of a severe fall-related injury (defined as a fracture or head injury requiring hospitalization) in the past 6 months that currently limits mobility assessment.
- Non-ambulatory or bed-bound patients.
- Patients with severe dementia (e.g., Mini-Mental State Examination score < 10) or diagnosed psychiatric conditions (e.g., psychosis, severe agitation) that would prevent cooperation.
- Expected hospital stay of less than 48 hours.
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 |
|---|---|---|
| Personalized Fall Prevention ProgramAn intervention package featuring a comprehensive, multidimensional risk assessment using an improved form and a dynamic functional test (Obstacle Physical Activity Ability Test). The assessment guided the development of a personalized prevention plan, including targeted exercises, environmental adjustments, and enhanced patient/family education. | Behavioural | Experimental: Personalized Fall Prevention Group |
| Standard Fall Prevention CareStandard hospital care for fall prevention, including universal precautions (e.g., clutter-free environment, non-slip footwear) and risk assessment using a standard hospital checklist. | Behavioural | Active Comparator: Standard Care Group |
Primary outcome
Fall Incidence
Time frame: Through study completion, an average of 10 days
The proportion of patients experiencing one or more falls. A fall was defined as an event which results in a person coming to rest inadvertently on the ground or floor or other lower level. It was recorded through the hospital's incident reporting system, patient self-report, and daily nursing checks.
5 secondary outcomes
Severity of Fall-Related Injury
Time frame: Through study completion, an average of 10 days
Nursing Satisfaction
Time frame: At discharge (an average of 10 days post-admission)
Patient Compliance
Time frame: Through study completion, an average of 10 days (assessed weekly)
Change in Physical Activity Ability
Time frame: Baseline and at discharge (an average of 10 days)
Change in Quality of Life (QoL)
Time frame: Baseline and at discharge (an average of 10 days)
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 17 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Fall Prevention Program and Standard Fall Prevention Care in people with Falls, run by The First Hospital of Hebei Medical University at 1 site in China.
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 3 inclusion and 5 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 17 Aug 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 China. 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?
Fall Incidence (time frame: Through study completion, an average of 10 days). 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 17 Aug 2025.