NCT05815875

Brief Summary

The goal of this interventional study will be to evaluate the effectiveness of the STEADI Program on falls and falling prevention compared with routine falling assessment in neurosurgical patients in Jordan. The researchers will compare the effectiveness of the STEADI intervention in the intervention group. Participants in the intervention group will be assessed for falls risk using well-established tools as recommended by the Centers for Disease Control and Prevention (CDC). The control group participants will receive regular falling assessment which involves using Morse Fall Scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

March 17, 2023

Last Update Submit

September 5, 2023

Conditions

Fall Patients

Keywords

Falls preventionNeurosurgery patientsSTEADI

Outcome Measures

Primary Outcomes (6)

  • The Stay Independent Brochure (SIB)

    The Stay Independent Brochure (SIB) will be used to assess the risk for falls as recommended by the CDC's STEADI. The SIB involves 12 items, and each item has a potential response of "No" (= 0) or "Yes" (= 1). Scoring relies on the number of "yes" answers to each question item, with a total possible score of 12. Participants are considered to be at risk of fall based on the following criteria: answer "yes" to 4 or more out of 12 questions, otherwise not at risk.

    Change from baseline to 5-days and 1-month

  • The clinician's 3 key questions

    The clinician's 3 key questions will also be used to assess the risk for falls as recommended by the CDC's STEADI. The three questions used are "fell in the past year?" "feel unsteady when standing or walking?" and "worries about walking?" Participants with a "yes" answer to any of the 3 key questions will be considered at risk of falls, and those with all "no" answers will be considered not at risk for falls.

    Change from baseline to 5-days and 1-month

  • Time Up and Go (TUG)

    The TUG is designed to evaluate mobility skills, balance, and fall risk. TUG performance is measured as the time taken to complete the test, with a longer completion time indicating poorer functional mobility and higher fall risk.

    Change from baseline to 5-days and 1-month

  • 30-Second Chair Stand

    The 30-S Chair Stand assesses lower extremity strength and endurance. This test uses a chair with a straight back without armrests and a seat height of 17 inches. The participant will sit in a chair with their arms crossed over their chest. When the investigator says "go," the participant will stand up and sit down again. And repeat this for 30 seconds. The investigator will count how many times a participant can do this. A lower number may mean the participant is at higher risk for a fall.

    Change from baseline to 5-days and 1-month

  • The 4-Stage Balance test

    The 4-Stage Balance test is an assessment of static balance in four different positions and increasingly challenging positions: (1) feet together, (2) instep of foot advanced to toe of other foot, (3) foot in front of other foot (tandem), and (4) and single-leg stance. Without being able to stand or lasting less than 10 seconds, all 4 types are considered to be at risk for falls, standing for 10 seconds or more is considered not at risk for falls.

    Change from baseline to 5-days and 1-month

  • Actual falls

    The actual number of falls will be recorded for all patients. Results will be reported as an average number of falls.

    At final (1-month) assessment

Study Arms (2)

Intervention

EXPERIMENTAL

The STEADI program will be applied to this group of participants. The STEADI involves frequent assessment of patients' risk for falls and making appropriate changes to decrease the risk for falls.

Combination Product: STEADI Program

Control

ACTIVE COMPARATOR

The STEADI program will not be applied to the control group participants. This group will receive the usual care provided to the patients in the hospital.

Other: Routine care

Interventions

STEADI ProgramCOMBINATION_PRODUCT

The investigators will conduct STEADI Algorithm for Falls Prevention educational sessions for healthcare providers in the neurosurgery unit, including doctors, nurses, physical therapists, and pharmacists. All healthcare providers in the neurosurgery unit will be invited to attend the educational sessions. Their participation will be voluntary and no obligations will be made, though. Healthcare providers will be invited to attend one 2-hour educational session. In each session, The investigators will have between 8-10 healthcare providers. The educational sessions will be delivered in the classroom available in the neurosurgery unit to facilitate the healthcare providers' access. PowerPoint presentations, videos, quizzes, case studies, and in-class discussions will be used to deliver learning content during the educational sessions. Healthcare providers will then be asked to apply the STEADI interventions on a group of patients.

Intervention
Routine careOTHER

The control group participants will receive routine care. Routine care involves only assessing for falls using Morse Falls Scale (MFS). MFS assesses a patient's fall risk upon admission, following a change in status, and at discharge or transfer to a new setting.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly admitted patients to the neurosurgery unit as a case of neurosurgery, have ≥4 scores on the Stay Independent Brochure (SIB), 18 years old or older.

You may not qualify if:

  • Bedridden and unconscious/comatose patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jehad Rababah

Irbid, 22110, Jordan

Location

Related Publications (1)

  • Stevens JA, Phelan EA. Development of STEADI: a fall prevention resource for health care providers. Health Promot Pract. 2013 Sep;14(5):706-14. doi: 10.1177/1524839912463576. Epub 2012 Nov 16.

    PMID: 23159993RESULT

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study will be conducted using a 1-month prospective quasi-experimental design. The study sample will be 70 neurosurgical patients at King Abdullah University Hospital. The study sample will be non-randomly divided into a control group (35 patients) and an intervention group (35 patients).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 18, 2023

Study Start

March 1, 2023

Primary Completion

July 31, 2023

Study Completion

August 31, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

The IPD will not be shared with other researchers. Only aggregate data will be disseminated.

Locations

JO(1)