Clinical trial NCT06833580: Effects of a Health Belief Model-Based Fall Prevention Education Program on Health Literacy and Physical Function in Patients with Chronic Stroke
Official title: Effects of a Health Belief Model-Based Fall Prevention Education Program on Health Literacy and Physical Function in Patients with Chronic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fall Prevention
Chronic Stroke Patients
Health Literacy
Education of Patients
Health Belief Model
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 8 weeks and will receive two in-person individual educational sessions based on the health belief model (HBM).


Eligibility criteria: Inclusion Criteria:

* Aged 60 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

Exclusion Criteria:

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

Primary outcomes:
measure: European Health Literacy Survey (HLS-EU-Q16)
timeFrame: Before intervention in week 1 and after intervention in week 6
measure: Falls Risk Questionnaire (FRQ)
timeFrame: Before intervention in week 1 and after intervention in week 6
measure: The Iconographical Falls Efficacy Scale - Short Version (Icon-FES)
timeFrame: Before intervention in week 1 and after intervention in week 6
Secondary outcomes:
measure: Five Times Sit-To-Stand (5TSTS)
timeFrame: Before intervention in week 1 and after intervention in week 6
measure: Time Up and Go (TUG)
timeFrame: Before intervention in week 1 and after intervention in week 6
measure: Stroke Specific Quality of Life Scale - Short Version (SS-QOL)
timeFrame: Before intervention in week 1 and after intervention in week 6
Other outcomes:
Locations:
Study officials:
References: