Fall PreventionNCT06833580
Effects of a Health Belief Model-Based Fall Prevention Education Program on Health Literacy and Physical Function in Patients With Chronic Stroke
A study testing The intervention group, who will receive the health belief model-based fall prevention education program in people with Fall Prevention and Chronic Stroke Patients, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to to evaluate the effects of a health belief model-based fall prevention education program on health literacy and physical function, fall rate, fall risk, fear of fall, and quality of life in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Fall Prevention, Chronic Stroke Patients, Health Literacy
- What is being tested?
- The intervention group, who will receive the health belief model-based fall prevention education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jul 2025to 12 Mar 2026
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 45 years and older
- Diagnosed with stroke (more than 6 months),
- No cognitive impairment (Arabic version of Mini-Mental State Examination [MMSE-A] score of 24 or more)
- No visual or hearing impairment
- Able to walk independently or with assistive devices for 10 meters
Who cannot join
- Severe communication deficiencies.
- Having neurological conditions other than stroke or other serious medical conditions that precluded participation in the study.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Prince Sultan military medical city
Riyadh, Riyadh Region
About this study
The goal of this clinical trial is to to evaluate the effects of a health belief model-based fall prevention education program on health literacy and physical function, fall rate, fall risk, fear of fall, and quality of life in patients with chronic stroke.
The main question it aim to answer is
Read more
- Does a health belief model-based fall prevention education program have a positive effect on health literacy, physical function, fall risk, fear of falling, and quality of life in patients with chronic stroke?
Researchers will compare the intervention group, who will receive the health belief model-based fall prevention education program, to the control group, who will receive their usual intervention in the physical therapy clinic, to see if the health belief model-based fall prevention education program has an effect on health literacy and physical function, fall rate, fall risk, fear of falling, and quality of life in patients with chronic stroke.
The clinical trial will be conducted in four phases; each participant will take around 6 weeks and will receive two in-person individual educational sessions based on the health belief model (HBM).
- Conditions
- Fall Prevention, Chronic Stroke Patients, Health Literacy, Education of Patients, Health Belief Model
- Being tested
- The intervention group, who will receive the health belief model-based fall prevention education program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention group, who will receive the health belief model-based fall prevention education programOther
Each participant in this group will receive two in-person individual educational sessions based on the health belief model (HBM).
| Study group | Role | What they receive |
|---|---|---|
| The intervention group (receive the health belief model-based fall prevention education program) | Experimental | Each participant in this group will receive two in-person individual educational sessions based on the health belief model (HBM) Receives: Other: The intervention group, who will receive the health belief model-based fall prevention education program |
| The control group, who will receive their usual intervention in the physical therapy clinic | No intervention | Each participant in this group will receive their usual intervention in the physical therapy clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Health Literacy Survey (HLS-EU-Q16)
The Arabic version of the European Health Literacy Survey Questionnaire (Ar- HLS-EU) will be used to assess health literacy (HL).
It is a self-reported questionnaire that consists of 16 items that measure the individual's ability to access, understand, process, and apply health information.
Each respondent expresses an opinion on a specific statement on the Likert 4-point scale (very easy, easy, difficult, very difficult).
The responses are dichotomized into easy (given a value of 1) and difficult (given a value of 0).
Total scores range from 0 to 16, in which zero represented the lowest possible HL and 16 represented the highest possible one. Then, participants' scores were categorized into inadequate (0-8), problematic (9-12), and sufficient (13-16) health literacy.
The HLS-EU-Q16 has been translated to the Arabic language and reported to be valid and reliable.
Measured: Before and after intervention and one month after the intervention
Falls Risk Questionnaire (FRQ)
FRQ is a self-reported questionnaire used to assess personal fall risk awareness. It contains 12 yes/no questions assessing different fall- risk factors in older adults.
The answers were scored as (No = 0) or (Yes = 2) for the first two questions and (Yes = 1) for the remaining 10 questions.
Individuals scoring four or more were considered at increased risk of falling. The Arabic version of FRQ It is highly valid and reliable in providing valuable data for evaluating fall risk.
Measured: Before and after intervention and one month after the intervention
The Iconographical Falls Efficacy Scale - Short Version (Icon-FES)
Short Version of Icon-FES will be used to assess concern about falling during 10 activities of daily living through a combination of images and brief descriptions.
Participants will be instructed to carefully observe each image and visualize themselves performing the activity.
Each item is rated on a 4-point scale (1 = not at all concerned to 4 = very concerned), with facial expression icons providing a visual representation of concern levels.
The total Icon-FES score ranges from 10 to 40, where 10-18 indicates low concern about falling, and 19-40 reflects high concern.
The Arabic short version of Icon-FES has been proven to be a reliable and valid tool for assessing fall-related concern in community-dwelling older adults.
Measured: Before and after intervention and one month after the intervention
Secondary outcomes (3)
Five Times Sit-To-Stand (5TSTS)
5TSTS will be used to assess functional lower extremity strength. It measured the time (in seconds) taken to complete 5 repetitions of the sit-to-stand from a seated position.
To perform the test, the patient sits in a standardized chair (height 43 cm and depth 47.5 cm), with arms crossed over his chest and with his back resting on the back of the chair.
The patients were instructed to stand up and sit down five times as fast as possible with the command "GO." The patient had to stand fully between repetitions of the test and not touch the back of the chair during each repetition. Timing began at "GO" and ended when the patient's back touched the backrest of the chair after the fifth repetition The shorter the time taken by the patient, the better their functional condition. 5STS is valid and has an excellent intraclass correlation coefficient (ICC) (range,.970-.976) in patients with chronic stroke
Measured: Before and after intervention and one month after the intervention
Time Up and Go (TUG)
TUG will be used to measure functional mobility and balance in a short time. The test involved standing up from a chair, walking 3 meters, turning, walking back to the chair, and sitting down.
Participants were allowed to use their walking aid and to use the armrest for support when getting up. The time will be recorded in seconds from standing up to sitting down.
TUG will be performed twice and the mean of the 2 trials will be used. A shorter time indicates better functional mobility. Patients who take ≥14 seconds to complete the TUG are at risk for falling.
TUG has been reported to have excellent test-retest reliability (ICC = 0.95-0.97) in patients with chronic stroke.
Measured: Before and after intervention and one month after the intervention
Stroke Specific Quality of Life Scale - Short Version (SS-QOL)
A short version of the Stroke Specific Quality of Life Scale will be used to assess quality of life. The SS-QOL-12-AR adopts a two-domain structure and incorporates 12 selected items derived from the original 49-item SSQOL-A scale.
The psychosocial domain includes seven items involving thinking, family roles, social roles, personality, mood, energy, and language. Additionally, the physical domain comprises five items addressing self-care, mobility, upper extremity function, vision, and work.
Each of the 12 items is assessed using a consistent five-point scale that aligns with its corresponding item in the original SSQOL-A scale.
Responses from each item are summed up, and the resulting composite score ranges from a minimum of 12 to a maximum of 60, with higher scores indicating a better QOL. The SS-QOL-12 has been translated to Arabic and it has excellent psychometric properties.
Measured: Before and after intervention and one month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jul 2025
- Primary completion1 Feb 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PreventionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuha Awadh Alharbi, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833580
- Sponsor's protocol ID
- E-24-9164
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Health Belief Model-Based Fall Prevention Education Program on Health Literacy and Physical Function in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06833580
- Acronym / sponsor ID
- E-24-9164
- Conditions
- Fall Prevention, Chronic Stroke Patients, Health Literacy, Education of Patients, Health Belief Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 19 Feb 2025 (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 clinical trial is to to evaluate the effects of a health belief model-based fall prevention education program on health literacy and physical function, fall rate, fall risk, fear of fall, and quality of life in patients with chronic stroke.
The main question it aim to answer is
- Does a health belief model-based fall prevention education program have a positive effect on health literacy, physical function, fall risk, fear of falling, and quality of life in patients with chronic stroke?
Researchers will compare the intervention group, who will receive the health belief model-based fall prevention education program, to the control group, who will receive their usual intervention in the physical therapy clinic, to see if the health belief model-based fall prevention education program has an effect on health literacy and physical function, fall rate, fall risk, fear of falling, and quality of life in patients with chronic stroke.
The clinical trial will be conducted in four phases; each participant will take around 6 weeks and will receive two in-person individual educational sessions based on the health belief model (HBM).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group (receive the health belief model-based fall prevention education program) | Experimental | Other: The intervention group, who will receive the health belief model-based fall prevention education programEach participant in this group will receive two in-person individual educational sessions based on the health belief model (HBM) |
| The control group, who will receive their usual intervention in the physical therapy clinic | No intervention | –Each participant in this group will receive their usual intervention in the physical therapy clinic |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 45 years and older
- Diagnosed with stroke (more than 6 months),
- No cognitive impairment (Arabic version of Mini-Mental State Examination [MMSE-A] score of 24 or more)
- No visual or hearing impairment
- Able to walk independently or with assistive devices for 10 meters
Key exclusion criteria (2 listed)
- Severe communication deficiencies.
- Having neurological conditions other than stroke or other serious medical conditions that precluded participation in the study.
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 |
|---|---|---|
| The intervention group, who will receive the health belief model-based fall prevention education programEach participant in this group will receive two in-person individual educational sessions based on the health belief model (HBM). | Other | The intervention group (receive the health belief model-based fall prevention education program) |
Primary outcome
European Health Literacy Survey (HLS-EU-Q16)
Time frame: Before and after intervention and one month after the intervention
The Arabic version of the European Health Literacy Survey Questionnaire (Ar- HLS-EU) will be used to assess health literacy (HL). It is a self-reported questionnaire that consists of 16 items that measure the individual's ability to access, understand, process, and apply health information. Each respondent expresses an opinion on a specific statement on the Likert 4-point scale (very easy, easy, difficult, very difficult). The responses are dichotomized into easy (given a value of 1) and difficult (given a value of 0). Total scores range from 0 to 16, in which zero represented the lowest possible HL and 16 represented the highest possible one. Then, participants' scores were categorized into inadequate (0-8), problematic (9-12), and sufficient (13-16) health literacy. The HLS-EU-Q16 has been translated to the Arabic language and reported to be valid and reliable.
Falls Risk Questionnaire (FRQ)
Time frame: Before and after intervention and one month after the intervention
FRQ is a self-reported questionnaire used to assess personal fall risk awareness. It contains 12 yes/no questions assessing different fall- risk factors in older adults. The answers were scored as (No = 0) or (Yes = 2) for the first two questions and (Yes = 1) for the remaining 10 questions. Individuals scoring four or more were considered at increased risk of falling. The Arabic version of FRQ It is highly valid and reliable in providing valuable data for evaluating fall risk.
The Iconographical Falls Efficacy Scale - Short Version (Icon-FES)
Time frame: Before and after intervention and one month after the intervention
Short Version of Icon-FES will be used to assess concern about falling during 10 activities of daily living through a combination of images and brief descriptions. Participants will be instructed to carefully observe each image and visualize themselves performing the activity. Each item is rated on a 4-point scale (1 = not at all concerned to 4 = very concerned), with facial expression icons providing a visual representation of concern levels. The total Icon-FES score ranges from 10 to 40, where 10-18 indicates low concern about falling, and 19-40 reflects high concern. The Arabic short version of Icon-FES has been proven to be a reliable and valid tool for assessing fall-related concern in community-dwelling older adults.
3 secondary outcomes
Five Times Sit-To-Stand (5TSTS)
Time frame: Before and after intervention and one month after the intervention
Time Up and Go (TUG)
Time frame: Before and after intervention and one month after the intervention
Stroke Specific Quality of Life Scale - Short Version (SS-QOL)
Time frame: Before and after intervention and one month after the intervention
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 13 Mar 2026.
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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 The intervention group, who will receive the health belief model-based fall prevention education program in people with Fall Prevention and Chronic Stroke Patients, run by King Saud University at 1 site in Saudi Arabia.
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 5 inclusion and 2 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 13 Mar 2026. 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 Saudi Arabia. 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?
European Health Literacy Survey (HLS-EU-Q16) (time frame: Before and after intervention and one month after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2026.