Chinese Version of LIVE-LiFE for Older Adults With Previous Falls

Multifaceted Fall Prevention Program for Chinese Community-dwelling Older Adults With Fall Risks: A Pilot Randomized Controlled Trial

The research is to solve the problem of the high incidence of falls among older adults in China. To this end, the investigators will develop a multi-dimensional fall prevention program by cultivating nursing students as community intervention personnel to address the current shortage of fall prevention programs and professional intervention in China. The research will make an important contribution to health care.

Study Overview

• Status: Recruiting
• Conditions: Accidental Falls
• Intervention / Treatment: Behavioral: Multi-dimensional fall prevention intervention program for 12 weeks

Detailed Description

The study intervention group is a 12-week multi-dimensional intervention, consisting of four parts: individualized balance and strength training, vision screening, drug evaluation, home risk assessment and home repair and transformation. Interventors will teach skills related to balance and strength training, incorporate these principles and exercises into daily and leisure activities, and how to increase the challenge of balance. The one-hour home visit aims to develop a personalized plan for participants by understanding each participant's health, exercise preferences, sedentary behaviors, and identifying needs related to the risk of falling. In particular, the interventionist will work with the participant to determine 6 skills or activities, and the participant hopes to practice ankle weight bearing at least 3 times a week based on their interests and abilities. Interventions and participants will work together to develop personal goals and plans, using exercise logs for gradual exercise, to continuously increase strength, resistance, weight, and challenge balance or strength. During home visits, the intervener will also assess participants' inherent risks by assessing their visual acuity, assess their home risk factors, and discuss with their caregiver or their children what risks would arise if the elderly live alone. In addition to group meetings and home visits, the interventionists will call to ask about progress and provide support and encouragement. Participants in the control group will receive the same amount of health education。

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minhui Liu, Ph.D; Phone Number: +86 133-7894-9466; Email: mliu62@jhu.edu

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 430100
      • Recruiting
      • Central South University
      • Contact: Yuqian Luo, Bachelor; Phone Number: 18175172084; Email: 207811018@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• age ≥60 years;
• Falls ≥2 times or injuries caused by falls ≥ 1times in the past year;

Exclusion criteria:

• residents who cannot live in a community in Changsha for more than 3 months, or who reside in a long-term care institution in Changsha;
• Moderate to severe cognitive impairment based on a simple and portable mental state questionnaire;
• Unable to walk independently;
• Has the nervous system condition which seriously affects its gait and activity;
• Any unstable or terminal illness that may interfere with planned exercise and is unlikely to be resolved;
• He is currently undergoing physical therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The intervention group; The intervention group of this study is a multi-dimensional intervention conducted by nursing students over a 12-week period, consisting of four parts: individualized balance and strength training, vision screening, drug evaluation, home risk assessment and home repair and transformation. These components were carried out through a combination of personal home visits and telephone interviews.	Behavioral: Multi-dimensional fall prevention intervention program for 12 weeks; The intervention group of this study is a multi-dimensional intervention conducted by nursing students over a 12-week period, consisting of four parts: individualized balance and strength training, vision screening, drug evaluation, home risk assessment and home repair and transformation. These components were carried out through a combination of personal home visits and telephone interviews.
No Intervention: The control group; The control group would receive the same amount of health education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Functioning:1.（short physical performance battery, SPPB）	SPPB is used to evaluate the comprehensive functions of lower limb muscle strength, balance, and walking, including 3 parts: 5 sit-ups, standing in series (including two feet standing side by side, one heel and the other side of the big toe standing sideways, one Stand with the heel of one foot close to the top of the big toe of the other foot) and walk 8 feet.	Three months
Physical Functioning:2. (timed get up and go test/the timed up and go test, TUG)	2. TUG involves balance in the sitting position, whether the transition from sitting to standing is smooth, walking gait, speed, and stability, and whether hesitant to turn around, etc., and can be used to evaluate the dynamic balance ability and mobility function.	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of falling was assessed by the Fall Efficacy Scale-International Chinese Version (FES-I (Ch)) Fear of falls was assessed by the Fall Efficacy Scale-International Chinese Version (FES-I (Ch))	FES-I (Ch) measures the degree of anxiety about falls among participants during 16 activities. The total score ranges from 16-64 points, a higher total score indicates a greater sense of fall efficacy. The original FES-I and FES-I (Ch) have good reliability (Cronbach's alpha: 0.96 ~ 0.97) and have structural validity in different studies.	Three months
Quality of life was measured using the Chinese version of the five EuroQol questionnaire (EQ-5D)	Participants will be asked if they have no problems in five dimensions, some or moderate questions, including actions, self-care, daily activities, pain / discomfort, anxiety / depression. The total score ranges from 0 to 100 points, higher scores mean a better quality of life.	Three months
Cognitive function and mental status are adopted: Mini-cog Test, Patient health questionnaire (PHQ-9).	(1) Mini-cog Test, which can be completed in 3 minutes, and is mostly used to distinguish whether or not they have dementia. The total score ranges 1 to 3, higher scores mean a better cognitive status. The scale has a sensitivity of 76% ～ 99%, specificity is 89% -93%, and has a good predictive value of dementia for the participants. (2) Patient health questionnaire (PHQ-9). This scale is used to understand how much time participants have been affected by 9 questions including depression and interest in the past two weeks. The total score ranges from 0 to 27, higher scores mean a worse depressive status. The researchers Summarized (PHQ-9) that the Cronbach's alpha used in the community elderly population was 0.832, the sensitivity was 88%, and the specificity was 99% 49.	Three months
Living habits and physical activities used: Physical Activity Scale for the Elderly (PASE), Activity of daily living function (ADL), Instrumental Daily Life Activity Ability Scale (IADL)	(1) Physical Activity Scale for the Elderly (PASE). The scale consists of 10 major categories of problems, including physical exercise, housework, and occupational physical activity. The total score range from 0 to 400, higher scores mean a better physical activity. (2) Activity of daily living function (ADL), which includes two parts: Physical Self-Maintenance Scale (PSMS; 6 items) and instrumental ability of daily living Scale (Instrumental Activity of Daily Living IADL; 8). Each entry is graded on a scale of 1 to 4. The total score ranges from 0 to 100, higher scores mean a worse ability of daily activity. (3) Instrumental Daily Life Activity Ability Scale (IADL): Includes recreation and leisure, use of transportation, cooking, housework maintenance, telephone use, medication, and financial management. The total score ranges from 0 to 56, higher scores mean a worse ability of instrumental daily activity.	Three months
Taking medications and dietary supplements uses the Beliefs About Medical Questionnaire (BMQ)	Medical Questionnaire (BMQ), which includes two sub-scales: the patient's general belief in any drug (BMQ-General) and specificity for a certain class of drugs Belief (BMQ-Specific). The researchers experimentally obtained the Cronbach's alpha coefficients of the two dimensions of the Chinese version of BMQ medication necessity and medication concern in elderly patients with depression; the retest reliability was 0.743 and 0.786, respectively; Degree coefficient (CVI) is 0.80 ~ 1.00	Three months

Collaborators and Investigators

• Sponsor: Sigma Theta Tau International
• Investigators: Principal Investigator: Minhui Liu, Ph.D, Central South University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2019
• Primary Completion (Anticipated): December 6, 2023
• Study Completion (Anticipated): December 12, 2023

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB00186421

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No