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

May 11, 2022 updated by: Minhui Liu, Sigma Theta Tau International

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Functioning:1.（short physical performance battery, SPPB）
Time Frame: Three months
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)
Time Frame: Three months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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))
Time Frame: Three months
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)
Time Frame: Three months
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).
Time Frame: Three months
(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)
Time Frame: Three months
(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)
Time Frame: Three months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sigma Theta Tau International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Minhui Liu, Ph.D, Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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