Accidental Falls, Older Adults
Conditions
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.
Interventions
BEHAVIORALFall prevention knowledge education
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.
BEHAVIORALExercise education
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.
BEHAVIORALHome hazard reduction education
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.
Sponsors
Southern Medical University, China
Guangzhou Center for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Exclusion of subjects with acute illness or acute stages of chronic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of falling in each group | Baseline, 6-month, 12-month | Falls will be monitored with supplied monthly fall diaries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fall efficacy in each group | Baseline, 6-month, 12-month | 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. |
| Quality of life in each group | Baseline, 6-month, 12-month | 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 |
Contacts
Primary ContactDong Roman Xu, Ph.D.
Backup ContactSherry Run Wang, Ph.D.
Outcome results
None listed