Health Education for Preventing Falls in Older Adults Living in the Community
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorGuangzhou Center for Disease Control and Prevention
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Exclusion of subjects with acute illness or acute stages of chronic disease
Trial design
Design model
Factorial
Treatments tested in this trial
Fall prevention knowledge education
BehavioralFrequency 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 education
BehavioralFrequency 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 education
BehavioralIntervention 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.
Treatment groups
888 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Fall prevention knowledge education & Exercise education & Home hazard reduction educationExperimental treatment 3 interventions
Group B: Fall prevention knowledge education & Exercise educationExperimental treatment 2 interventions
Group C: Fall prevention knowledge education & Home hazard reduction educationExperimental treatment 2 interventions
Group D: Exercise education & Home hazard reduction educationExperimental treatment 2 interventions
Group E: Fall prevention knowledge education onlyExperimental treatment 1 intervention
Group F: Exercise education onlyExperimental treatment 1 intervention
Group G: Home hazard reduction education onlyExperimental treatment 1 intervention
Group H: Care as usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The rate of falling in each group
Falls will be monitored with supplied monthly fall diaries.
Time frame
Baseline, 6-month, 12-monthSecondary outcomes
1
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.
Time frame
Baseline, 6-month, 12-month2
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
Time frame
Baseline, 6-month, 12-monthLocations
Sponsors and contacts
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Guangzhou Center for Disease Control and Prevention
Lead sponsor
Southern Medical University, China
Collaborator
Source ClinicalTrials.gov
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