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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05815875
Other study ID # 92-2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date August 31, 2023

Study information

Verified date September 2023
Source King Abdullah University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The STEADI (Stopping Elderly Accidents, Deaths & Injuries) program was developed by the Centers for Disease Control and Prevention (CDC) to help healthcare providers address falls among older adults. The STEADI program provides healthcare providers with tools and resources to screen their older patients for fall risk, assess risk factors, and develop and implement an individualized fall prevention plan. The STEADI program is an evidence-based approach to fall prevention and has been shown to reduce falls among older adults. However, evidence regarding the effectiveness and usefulness of the STEADI among neurosurgery patients is lacking. The investigators of the current research will conduct a 2-hour educational session to train healthcare providers in a neurosurgery unit on using the STEADI tools and algorithm. Then, the investigators will collect data to assess whether applying the STEADI decreases the risk for falls in neurosurgery patients.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date August 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Bedridden and unconscious/comatose patients

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
STEADI Program
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.
Other:
Routine care
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.

Locations

Country Name City State
Jordan Jehad Rababah Irbid

Sponsors (2)

Lead Sponsor Collaborator
King Abdullah University Hospital Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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