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

NCT ID: NCT06833580

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-03-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Each 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

Each participant in this group will receive their usual intervention in the physical therapy clinic

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Nuha Awadh Alharbi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince Sultan military medical city

Riyadh, Riyadh Region, Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Facility Contacts

Nuha Awadh Alharbi

Role: primary

nuhaharbi@psmmc.med.sa

00966548582469

Other Identifiers

E-24-9164

Identifier Type: -

Identifier Source: org_study_id