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NCT Number: NCT07126925

A Trial of an Improved Fall Risk Assessment and Activity Test to Prevent Falls in Elderly Inpatients

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.

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Key information

Conditions

Falls

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Personalized Fall Prevention Program

Behavioral

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 Care

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Severity of Fall-Related Injury

    Time frame: Through study completion, an average of 10 days

    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).

  2. Nursing Satisfaction

    Time frame: At discharge (an average of 10 days post-admission)

    Patient-reported satisfaction with nursing communication, responsiveness, and fall prevention education, measured using a 5-item institutional survey on a 10-point scale.

  3. Patient Compliance

    Time frame: Through study completion, an average of 10 days (assessed weekly)

    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.

  4. Change in Physical Activity Ability

    Time frame: Baseline and at discharge (an average of 10 days)

    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.

  5. Change in Quality of Life (QoL)

    Time frame: Baseline and at discharge (an average of 10 days)

    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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Effectiveness of an Improved Fall Risk Assessment Form Combined With Obstacle Physical Activity Testing in Preventing Falls in Elderly Hospitalized Patients

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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