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

NCT ID: NCT07126925

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-31

Brief 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. 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.

Conditions

Falls

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental: Personalized Fall Prevention Group

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.

Group Type: EXPERIMENTAL

Personalized Fall Prevention Program

Intervention Type: 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.

Active Comparator: Standard Care Group

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.

Group Type: ACTIVE_COMPARATOR

Standard Fall Prevention Care

Intervention Type: 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.

Interventions

Personalized Fall Prevention Program

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.

Intervention Type: BEHAVIORAL

Standard Fall Prevention Care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yang Lu

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2022S0477

Identifier Type: -

Identifier Source: org_study_id