Health Education for Preventing Falls in Older Adults Living in the Community
1 other identifier
interventional
888
0 countries
N/A
Brief Summary
This clinical trial aims to evaluate the effectiveness of three health education intervention modules in preventing falls among older adults living in the community. The study is designed as a factorial randomized controlled trial, assessing the impact of three health education intervention modules: Fall prevention knowledge education，Exercise education, and Home hazard reduction education. Each module will have a 'yes' and 'no' version, resulting in eight experimental conditions. The primary questions it seeks to address are: (1) What is the main effect of different health education intervention modules on preventing falls in older adults living in the community? (2)What is the interactive effect of different health education intervention modules on preventing falls in older adults living in the community? The trial will be conducted in twenty four sub-district in Baiyun District, Guangzhou City. An estimated 37 participants will be recruited from each of the 24 sub-districts, with the sub-districts being randomly assigned to one of the eight experimental groups by a statistician independent of the research team using computer-generated random numbers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2024
CompletedFirst Posted
Study publicly available on registry
July 18, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJuly 18, 2024
July 1, 2024
6 months
June 27, 2024
July 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of falling in each group
Falls will be monitored with supplied monthly fall diaries.
Baseline, 6-month, 12-month
Secondary Outcomes (2)
Fall efficacy in each group
Baseline, 6-month, 12-month
Quality of life in each group
Baseline, 6-month, 12-month
Study Arms (8)
Fall prevention knowledge education & Exercise education & Home hazard reduction education
EXPERIMENTALFall Prevention Education: Form a health education group for the intervention subjects to learn about fall prevention. The project team will teach through talks, discussions, and shared experiences to boost their understanding and concepts on preventing falls. Exercise Education: In group settings, the project team will instruct participants on exercises to prevent falls, focusing on balance, leg strength, and endurance, and demonstrate the use of assistive tools. Home Hazard Reduction: Staff will visit homes to assess and guide on reducing fall risks, teaching participants to identify and suggest changes to home environment hazards.
Fall prevention knowledge education & Exercise education
EXPERIMENTALThe intervention in this arm consists of the following two components： Component 1: Fall prevention knowledge education To organise the study subjects in the intervention group to set up a falls prevention health education activity group, in which the project team will disseminate the knowledge and concepts of falls prevention through lectures, discussions, questions and answers, and sharing, so as to enhance the knowledge base required by the study subjects to prevent falls as well as to cultivate the relevant concepts. Component 2: Exercise education Using the group activities of the intervention group, through lectures, demonstrations, on-site exercises and practices, the project team taught the intervention group participants fall prevention exercise skills such as improvement of balance function, enhancement of lower limb muscle strength, endurance exercise, etc., and the use of fall prevention related assistive tools.
Fall prevention knowledge education & Home hazard reduction education
EXPERIMENTALThe intervention in this arm consists of the following two components： Component 1: Fall prevention knowledge education To organise the study subjects in the intervention group to set up a falls prevention health education activity group, in which the project team will disseminate the knowledge and concepts of falls prevention through lectures, discussions, questions and answers, and sharing, so as to enhance the knowledge base required by the study subjects to prevent falls as well as to cultivate the relevant concepts. Component 2: Home hazard reduction education Through the staff's in-home assessment and guidance, the project team instructed the study participants to assess the fall-related home environment risk factors and make recommendations for modifications.
Exercise education & Home hazard reduction education
EXPERIMENTALThe intervention in this arm consists of the following two components： Component 1: Exercise education Using the group activities of the intervention group, through lectures, demonstrations, on-site exercises and practices, the project team taught the intervention group participants fall prevention exercise skills such as improvement of balance function, enhancement of lower limb muscle strength, endurance exercise, etc., and the use of fall prevention related assistive tools. Component 2: Home hazard reduction education Through the staff's in-home assessment and guidance, the project team instructed the study participants to assess the fall-related home environment risk factors and make recommendations for modifications.
Fall prevention knowledge education only
EXPERIMENTALFall prevention knowledge education: To organise the study subjects in the intervention group to set up a falls prevention health education activity group, in which the project team will disseminate the knowledge and concepts of falls prevention through lectures, discussions, questions and answers, and sharing, so as to enhance the knowledge base required by the study subjects to prevent falls as well as to cultivate the relevant concepts.
Exercise education only
EXPERIMENTALExercise education: Using the group activities of the intervention group, through lectures, demonstrations, on-site exercises and practices, the project team taught the intervention group participants fall prevention exercise skills such as improvement of balance function, enhancement of lower limb muscle strength, endurance exercise, etc., and the use of fall prevention related assistive tools.
Home hazard reduction education only
EXPERIMENTALHome hazard reduction education: Through the staff's in-home assessment and guidance, the project team instructed the study participants to assess the fall-related home environment risk factors and make recommendations for modifications.
Care as usual
NO INTERVENTIONInterventions
Frequency of Intervention: 4 sessions, 60 mins each, weeks 1, 3, 5, 8. Intervention format：group intervention, 12-15 participants in one group. Intervention content: Elderly fall risks, home safety improvements, community hazard identification, behavior modification. Intervention tools: digital teaching PPTs. Intervention deliverers: 2 members per community, one as leader for organizing health ed. activities (lectures, discussions, exercises, Q\&A), the other as assistant for support and participant safety during exercises.
Frequency of intervention: 4 sessions Duration of intervention: 30 minutes/session, once in each of the 1st, 3rd, 5th and 8th weeks of the intervention period. Intervention format: group intervention, 12 people in a group (in principle, no more than 15 people). Intervention content: The content of health education included (1) basic knowledge of exercise safety, 4 methods of balance function exercise (2) review 4 methods of balance function exercise(3) methods of exercising muscle strength (4) 2 methods of endurance exercise. Intervention tools: accompanying teaching materials Intervention deliverers: same as before.
Intervention Time: One home fall risk assessment and modification instruction at week 6 of health education. Frequency of Intervention: Single session. Intervention Format: Project staff conduct in-home fall risk assessments by appointment. Intervention Content: 1. Evaluate fall risks in elderly living areas. 2. Provide personal guidance, complete two written forms-one for records, one for the participants. 3. Supply night lights, anti-slip mats, warning signs, and carpet mats; more services encouraged where possible. Intervention Tools: Utilize "Elderly Home Fall Risk and Retrofitting Guide" for detailed assessments and suggestions. Include tools like night lights, mats, and signs. Intervention Deliverers: Skilled community social workers or community health center staff.
Eligibility Criteria
You may qualify if:
- Age 60-80 inclusive
- Live in the community
- Expected to live in their current place of residence for the next 12 months
- can walk 50 metres without the assistance of an assistive device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2024
First Posted
July 18, 2024
Study Start
August 1, 2024
Primary Completion
February 1, 2025
Study Completion
August 1, 2025
Last Updated
July 18, 2024
Record last verified: 2024-07