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

NCT07126925 | Completed

• 1 other identifier: 2022S0477
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Falls

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 10 days

Secondary Outcomes (5)

• Severity of Fall-Related Injury

  Through study completion, an average of 10 days

• Nursing Satisfaction

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

• Patient Compliance

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

• Change in Physical Activity Ability

  Baseline and at discharge (an average of 10 days)

• Change in Quality of Life (QoL)

  Baseline and at discharge (an average of 10 days)

Study Arms (2)

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.

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.

Behavioral: Standard Fall Prevention Care

Interventions

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.

Experimental: Personalized Fall Prevention Group

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.

Active Comparator: Standard Care Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 17, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

CN (1)