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| Name | Class |
|---|---|
| Southern Medical University, China | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Fall prevention knowledge education & Home hazard reduction education |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fall prevention knowledge education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of falling in each group | Falls will be monitored with supplied monthly fall diaries. | Baseline, 6-month, 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6-month, 12-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Roman Xu, Ph.D. | Contact | 13910988979 | roman.xu@gmail.com | |
| Sherry Run Wang, Ph.D. | Contact | 19865182576 | runwang@i.smu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 3, 2024 | Jul 7, 2024 | Prot_SAP_ICF_000.pdf |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Care as usual | No Intervention |
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| Exercise education | Behavioral | 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. |
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| Home hazard reduction education | Behavioral | 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:
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. |
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| 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 | Baseline, 6-month, 12-month |