Health Education for Preventing Falls in Older Adults Living in the Community

NCT ID: NCT06507020

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

888 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Accidental Falls Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Fall prevention knowledge education & Exercise education & Home hazard reduction education

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.

Group Type EXPERIMENTAL

Fall prevention knowledge education

Intervention Type 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.

Exercise education

Intervention Type 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.

Home hazard reduction education

Intervention Type 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:

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.

Fall prevention knowledge education & Exercise education

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.

Group Type EXPERIMENTAL

Fall prevention knowledge education

Intervention Type 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.

Exercise education

Intervention Type 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.

Fall prevention knowledge education & Home hazard reduction education

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.

Group Type EXPERIMENTAL

Fall prevention knowledge education

Intervention Type 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.

Home hazard reduction education

Intervention Type 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:

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.

Exercise education & Home hazard reduction education

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.

Group Type EXPERIMENTAL

Exercise education

Intervention Type 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.

Home hazard reduction education

Intervention Type 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:

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.

Fall prevention knowledge education only

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.

Group Type EXPERIMENTAL

Fall prevention knowledge education

Intervention Type 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.

Exercise education only

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.

Group Type EXPERIMENTAL

Fall prevention knowledge education

Intervention Type 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.

Home hazard reduction education only

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.

Group Type EXPERIMENTAL

Fall prevention knowledge education

Intervention Type 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.

Care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fall 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.

Intervention Type BEHAVIORAL

Exercise 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.

Intervention Type BEHAVIORAL

Home 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southern Medical University, China

OTHER

Sponsor Role collaborator

Guangzhou Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Dong Roman Xu, Ph.D.

Role: CONTACT

13910988979

Sherry Run Wang, Ph.D.

Role: CONTACT

19865182576

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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GZCDC-ECHR-2024P0116

Identifier Type: -

Identifier Source: org_study_id

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