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

Not Applicable

Not yet recruiting

• Conditions: Older Adults; Accidental Falls

• Registration Number: NCT06507020
• Lead Sponsor: Guangzhou Center for Disease Control and Prevention

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-27
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18
• Study Start: 2024-08-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 888

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
The rate of falling in each group	Baseline, 6-month, 12-month	Falls will be monitored with supplied monthly fall diaries.

Secondary Outcome Measures

Name	Time	Method
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