Effects of a Health Belief Model-Based Fall Prevention Education Program on Health Literacy and Physical Function in Patients With Chronic Stroke

NCT06833580 | Completed

• 1 other identifier: E-24-9164
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Fall Prevention; Chronic Stroke Patients; Health Literacy; Education of Patients; Health Belief Model

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Before and after intervention and one month after the intervention

Secondary Outcomes (3)

• Five Times Sit-To-Stand (5TSTS)

  Before and after intervention and one month after the intervention

• Time Up and Go (TUG)

  Before and after intervention and one month after the intervention

• Stroke Specific Quality of Life Scale - Short Version (SS-QOL)

  Before and after intervention and one month after the intervention

Study Arms (2)

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)

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

Interventions

The intervention group, who will receive the health belief model-based fall prevention education program OTHER

Each participant in this group will receive two in-person individual educational sessions based on the health belief model (HBM).

The intervention group (receive the health belief model-based fall prevention education program)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe communication deficiencies.
• Having neurological conditions other than stroke or other serious medical conditions that precluded participation in the study.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

Prince Sultan military medical city

Riyadh, Riyadh Region, Saudi Arabia

Location

Study Design

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

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 19, 2025
• Study Start: July 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 12, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-02

Locations

SA (1)