Fall PatientsNCT05815875
The Effect of The STEADI Program on Falls and Falls Prevention in Neurosurgical Patients in Jordan
A study testing STEADI Program and Routine care in people with Fall Patients, run by King Abdullah University Hospital at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fall Patients
- What is being tested?
- STEADI Program and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteJordan
- Study dates
- 1 Mar 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Bedridden and unconscious/comatose patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Fall Patients
- Being tested
- STEADI Program, Routine care
- Keywords
- Falls prevention, Neurosurgery patients, STEADI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At final (1-month) assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Mar 2023
- Primary completion31 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fall PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Jehad Rababah, King Abdullah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815875
- Sponsor's protocol ID
- 92-2023
- Status last verified
- Sep 2023
- First submitted
- 17 Mar 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared with other researchers. Only aggregate data will be disseminated.
Publications
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.
PubMed 23159993
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The STEADI Program on Falls and Falls Prevention in Neurosurgical Patients in Jordan
- ClinicalTrials.gov ID
- NCT05815875
- Acronym / sponsor ID
- 92-2023
- Conditions
- Fall Patients
- Keywords
- Falls prevention, Neurosurgery patients, STEADI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: STEADI ProgramThe 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. |
| Control | Active comparator | Other: Routine careThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Bedridden and unconscious/comatose patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEADI ProgramThe 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. | Combination product | Intervention |
| Routine careThe 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. | Other | Control |
Primary outcome
The Stay Independent Brochure (SIB)
Time frame: Change from baseline to 5-days and 1-month
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.
The clinician's 3 key questions
Time frame: Change from baseline to 5-days and 1-month
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.
Time Up and Go (TUG)
Time frame: Change from baseline to 5-days and 1-month
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.
30-Second Chair Stand
Time frame: Change from baseline to 5-days and 1-month
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.
The 4-Stage Balance test
Time frame: Change from baseline to 5-days and 1-month
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.
Actual falls
Time frame: At final (1-month) assessment
The actual number of falls will be recorded for all patients. Results will be reported as an average number of falls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Results publication: PubMed 23159993Stevens 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.
- Individual participant dataSharing planned: No. The IPD will not be shared with other researchers. Only aggregate data will be disseminated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEADI Program and Routine care in people with Fall Patients, run by King Abdullah University Hospital at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Stay Independent Brochure (SIB) (time frame: Change from baseline to 5-days and 1-month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05815875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.