Accidental FallsNCT06507020
Health Education for Preventing Falls in Older Adults Living in the Community
A study testing Fall prevention knowledge education, Exercise education and Home hazard reduction education in people with Accidental Falls and Older Adults, run by Guangzhou Center for Disease Control and Prevention.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Older Adults
- What is being tested?
- Fall prevention knowledge education, Exercise education and Home hazard reduction education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 888 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2025
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Exclusion of subjects with acute illness or acute stages of chronic disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Health Education for Preventing Falls in Older Adults Living in the Community: a Factorial Randomized Controlled Trial
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.
- Conditions
- Accidental Falls, Older Adults
- Being tested
- Fall prevention knowledge education, Exercise education, Home hazard reduction education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall prevention knowledge educationBehavioural
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.
Exercise educationBehavioural
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.
Home hazard reduction educationBehavioural
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:
- Evaluate fall risks in elderly living areas.
- Provide personal guidance, complete two written forms-one for records, one for the participants.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Fall prevention knowledge education & Exercise education & Home hazard reduction education | Experimental | Fall 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. Receives: Behavioral: Fall prevention knowledge education; Behavioral: Exercise education; Behavioral: Home hazard reduction education |
| Fall prevention knowledge education & Exercise education | Experimental | The 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. Receives: Behavioral: Fall prevention knowledge education; Behavioral: Exercise education |
| Fall prevention knowledge education & Home hazard reduction education | Experimental | The 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. Receives: Behavioral: Fall prevention knowledge education; Behavioral: Home hazard reduction education |
| Exercise education & Home hazard reduction education | Experimental | The 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. Receives: Behavioral: Exercise education; Behavioral: Home hazard reduction education |
| Fall prevention knowledge education only | Experimental | 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. Receives: Behavioral: Fall prevention knowledge education |
| Exercise education only | Experimental | 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. Receives: Behavioral: Fall prevention knowledge education |
| Home hazard reduction education only | Experimental | 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. Receives: Behavioral: Fall prevention knowledge education |
| Care as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of falling in each group
Falls will be monitored with supplied monthly fall diaries.
Measured: Baseline, 6-month, 12-month
Secondary outcomes (2)
Fall efficacy in each group
Fall efficacy will be monitored with 'Falls Efficacy Scale International, FES-I', and each item is scored on a scale of 1 to 4 (from "not at all confident" to "very confident"), with a total score of 16 to 64, with higher scores indicating a greater sense of fall efficacy or self-confidence.
Measured: Baseline, 6-month, 12-month
Quality of life in each group
Quality of life will be monitored with 'the 12-item MOS Short-form Health Survey version 2, SF-12 V.2'. All entries except 1, 8, 9 and 10 are positively scored and the total score is calculated by the scale's unique standardised method, with a minimum score of 0 and a maximum score of 100
Measured: Baseline, 6-month, 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 888 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- Southern Medical University, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507020
- Sponsor's protocol ID
- GZCDC-ECHR-2024P0116
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 18 Jul 2024
- 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 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Education for Preventing Falls in Older Adults Living in the Community: a Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06507020
- Acronym / sponsor ID
- GZCDC-ECHR-2024P0116
- Conditions
- Accidental Falls, Older Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 888 participants (estimated)
- Lead sponsor
- Guangzhou Center for Disease Control and PreventionOther government
- Collaborators
- Southern Medical University, China
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 18 Jul 2024 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Fall prevention knowledge education & Exercise education & Home hazard reduction education | Experimental | Behavioral: Fall prevention knowledge education, Behavioral: Exercise education, Behavioral: Home hazard reduction educationFall 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 | Experimental | Behavioral: Fall prevention knowledge education, Behavioral: Exercise educationThe 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 | Experimental | Behavioral: Fall prevention knowledge education, Behavioral: Home hazard reduction educationThe 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 | Experimental | Behavioral: Exercise education, Behavioral: Home hazard reduction educationThe 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 | Experimental | Behavioral: Fall prevention knowledge educationFall 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 | Experimental | Behavioral: Fall prevention knowledge educationExercise 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 | Experimental | Behavioral: Fall prevention knowledge educationHome 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 intervention | – |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Exclusion of subjects with acute illness or acute stages of chronic disease
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 |
|---|---|---|
| Fall prevention knowledge educationFrequency 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. | Behavioural | Exercise education only, Fall prevention knowledge education & Exercise education, Fall prevention knowledge education & Exercise education & Home hazard reduction education, Fall prevention knowledge education & Home hazard reduction education, Fall prevention knowledge education only, Home hazard reduction education only |
| Exercise educationFrequency 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. | Behavioural | Exercise education & Home hazard reduction education, Fall prevention knowledge education & Exercise education, Fall prevention knowledge education & Exercise education & Home hazard reduction education |
| Home hazard reduction educationIntervention 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. | Behavioural | Exercise education & Home hazard reduction education, Fall prevention knowledge education & Exercise education & Home hazard reduction education, Fall prevention knowledge education & Home hazard reduction education |
Primary outcome
The rate of falling in each group
Time frame: Baseline, 6-month, 12-month
Falls will be monitored with supplied monthly fall diaries.
2 secondary outcomes
Fall efficacy in each group
Time frame: Baseline, 6-month, 12-month
Quality of life in each group
Time frame: Baseline, 6-month, 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fall prevention knowledge education, Exercise education and Home hazard reduction education in people with Accidental Falls and Older Adults, run by Guangzhou Center for Disease Control and Prevention.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Roman Xu, Ph.D. (13910988979, roman.xu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of falling in each group (time frame: Baseline, 6-month, 12-month). 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 18 Jul 2024.