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

Accidental Falls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377801
• Other study ID #: IRB00186421
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: December 12, 2023

Study information

• Verified date: May 2022
• Source: Sigma Theta Tau International
• Contact: Minhui Liu, Ph.D
• Phone: +86 133-7894-9466
• Email: mliu62[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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。

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 12, 2023
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Accidental Falls

Intervention

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.

Locations

Country	Name	City	State
China	Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Sigma Theta Tau International

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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