Health Education for Preventing Falls in Older Adults Living in the Community: a Factorial Randomized Controlled Trial
Phase: NA
Conditions: Accidental Falls, Older Adults
Sponsor: Guangzhou Center for Disease Control and Prevention

Pilot Project Programme for Prevention of Falls
among Community-dwelling Elderly in Guangzhou
Guangzhou Centre for Disease Control and Prevention
June 2024

Table of Content
I. BACKGROUND OF THE STUDY.............................................................................................................................3
II. OBJECTIVES OF THE STUDY................................................................................................................................6
III. STUDY SUBJECTS..................................................................................................................................................7
IV. INTERVENTION STRATEGIES............................................................................................................................10
V. MAIN INTERVENTION ACTIVITIES................................................................................................................... 11
VI. PROJECT EVALUATION...................................................................................................................................... 15
VII. METHODS OF STATISTICAL ANALYSIS.........................................................................................................27
VIII. SAFETY GUARANTEE......................................................................................................................................29
IX. QUALITY CONTROL............................................................................................................................................30
X. RESEARCH FLOW CHART...................................................................................................................................35
XI. ORGANISATIONAL MANAGEMENT AND DIVISION OF RESPONSIBILITIES..........................................36

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Pilot
Project
Programme
on
Prevention
of
Falls
among
Community-dwelling Elderly in Guangzhou
I. Background of the study
According to China's seventh population census, the population aged 60 and above
reached 264 million in 2020, accounting for 18.7 per cent of the total population, and by
2025, the total number of elderly people will exceed 300 million. Falls are the leading
cause of injury and death among the elderly, and 20-30 per cent of elderly people who
recover from fall-related injuries will suffer a decline in self-care ability or even
premature death. Currently, China has a large elderly population in urban communities,
and falls among the elderly have become a public health issue of public concern.In 2019,
the State Council issued the Opinions on the Implementation of Healthy China Actions,
which emphasises "accelerating the promotion of the shift from treating illnesses as the
centre of health care to people's health as the centre of health care", and will "
Implementing health promotion actions for the elderly" as an important part of
maintaining health throughout the life cycle. Falls in the elderly are not an accident, but
the result of the interaction of multiple risk factors. Most of these risk factors can be
changed and prevented. At this stage, the majority of older people in our city live in the
community, and about 61.7 per cent of falls occur at home or in other community settings.
The community is the main venue for the implementation of the strategy of "prevention
first, moving the gate forward, and lowering the centre of gravity" for the prevention and
control of chronic diseases. However, there are no evidence-based scientific and
systematic intervention techniques, models and tools that can be directly scaled up in our
city.In 2022, there will be only 16.84 public health doctors and 112 public health nurses
per 100,000 people in our city, and public health services are severely under-resourced

4
due to the surge in the number of patients suffering from chronic diseases such as
diabetes and high blood pressure. The healthcare system is also facing an increasing
economic burden and unprecedented challenges. Therefore, it is important to explore a
fall prevention intervention service model that meets the city's economic, cultural, and
environmental conditions under limited community healthcare resources, so that more
older adults can benefit from fall prevention intervention services to improve the quality
of life of older adults and to reduce the burden of healthcare.
Risk factors for falls in older people include gait and balance disorders, visual
impairment, syncope and arrhythmia, irrational use of medication, foot disorders and
environmental hazards. Intervention studies on falls in the elderly began in developed
regions and countries in the 1980s, and the studies were mainly divided into two
categories: single-factor interventions targeting a single risk factor and multifactorial
interventions targeting multiple risk factors. Since the 1990s, there has been a gradual
increase in the number of multifactorial intervention studies on falls in older adults in
developed countries, and the number of high-quality randomised controlled studies has
also gradually increased. Existing evidence suggests that targeted interventions targeting
the various risk factors for falls in older adults are the most effective strategy for
preventing
falls
in
older
adults.
Population-based
community-based
integrated
interventions that address single risk factors, such as improving balance function and
home environment, can also be effective in preventing falls in older adults and reducing
the severity of injuries caused by falls. Based on this, the research group organised two
rounds of the project "Research on the Effectiveness of Community-Based Intervention
of Health Education Group Activities for Fall Prevention in the Elderly" in 2020 and
2022 in some communities in Guangzhou. The project is a multifactorial intervention
based on the community population, through the implementation of seven health
education
programmes,
including
fall
risk
assessment
and
management,
health
self-management skills, exercise guidance, rational use of medication, and one

5
door-to-door modification of the fall-related hazardous environment. Twelve months
after the first round of the project, the incidence of falls in the intervention group was
4.35%, compared with 24% in the control group, p < 0.05. Both rounds of the project
were effective in raising the awareness of fall prevention and the level of fall prevention
knowledge and skills among the elderly, and reducing the number of falls, which resulted
in a better intervention effect.
However, the intervention programme of seven health education classes and one
home assessment in the pre-programme, if it needs to be widely promoted in our city,
may put more pressure on the existing working mode of primary healthcare institutions,
and the curriculum needs to be streamlined for easy promotion. In addition, the
effectiveness
of
individual
intervention
components
was
not
studied
in
the
pre-intervention, and the mechanism of action of individual elements of the intervention
with respect to outcome effects could not be confirmed. When the performance of
individual intervention components is unknown, it is not clear which factor has the least
effect on outcomes. The components selected for removal may be the main cause of any
effects observed in the RCT, and therefore may result in a streamlined intervention that is
less effective or even ineffective.
Therefore, this study intends to build on the results of the previous research,
selecting community elderly in Baiyun District as the intervention target, assessing the
fall risk factors of the intervention target through qualitative analysis of fall risk, and
targeting the formation of health education activity groups; the intervention target of each
group randomly receives different combinations of interventions under the guidance of
professional and technical personnel; and evaluating the effects of different interventions
through a randomised controlled trial with analytic factor design to screen the The
effectiveness of different interventions will be evaluated through a randomised controlled
trial with a causal analysis design, in order to screen the comprehensive intervention
elements, optimise the mode of intervention combinations, and save the research

6
resources and costs; furthermore, the study will provide scientific references and
practical tools for the city to carry out the fall intervention services for the elderly
applicable to the primary healthcare institutions, and ultimately reduce the incidence of
falls among the elderly, and improve the quality of their lives.
II. Objectives of the Study
(1) General objectives of the study
Using a multi-stage optimisation strategy, the group will optimise the project
intervention programme in the improvement phase, conduct a randomised controlled trial
using a factorial design, quantitatively compare the effects of different falls programmes
on falls prevention, carry out an economic evaluation of the different intervention groups,
and ultimately determine the optimal combination of intervention strategies for the
project. To explore and establish a community-based falls prevention intervention model
for the elderly, and to provide a scientific basis and a practical tool for the establishment
of a community-based falls prevention service model for the elderly that is suitable for
implementation by primary healthcare organisations in the city. Ultimately, through
city-wide dissemination and implementation, we will achieve the goal of reducing the
incidence of falls among older adults and improving their quality of life.
(2) Specific objectives
1. To be achieved through a 2-month intervention for the target population within 12
months after the start of the implementation of the intervention:
1.1 Apply a multi-stage optimisation strategy, centred on an analytic design
randomised controlled trial, to screen for elements of a community falls prevention
intervention for older people and optimise a comprehensive intervention management
strategy for community falls prevention in older people;

7
1.2 Evaluate the inputs and outputs of the multifactorial intervention strategy for the
prevention of falls in older people, to provide a basis for the dissemination of the
intervention strategy and government decision-making.
III. Study subjects
The researcher used the Screening Form for Research Subjects (Annex 2) to select
eligible elderly people as research subjects among the elderly population by means of
questionnaires and scale assessments.
(1) Study subjects
All 24 streets within Baiyun District of Guangzhou City were included in the study
area. Sampling should take into account the state of socio-economic development, the
age of the population, the gender ratio of the neighbourhood committees (villages) as
consistent as possible, and the balanced distribution of the sample; taking into account
the principle of cost-effectiveness and the feasibility of the sampling scheme. Through
centralised open recruitment, household recruitment and other forms of recruitment,
followed by face-to-face survey, telephone survey, on-site assessment, etc., eligible
elderly people are selected as intervention research subjects and randomly assigned to
each intervention group.
1.1 Inclusion Criteria for Research Subjects
1.1.1 Inclusion criteria:

Age 60-80 years old, including 60 and 80 years old

Living 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

8
1.1.2 Exclusion criteria:

Exclusion of study subjects with acute illnesses or acute stages of chronic
diseases
1.1.3 Requirements for the proportion of recruited subjects
In order to increase the homogeneity of study subjects, study subjects can be
recruited with reference to the following gender and age requirements:
①20% male, 80% female; ②30%-35% aged 60-65 years, ③30%-35% aged
66-70 years, ④30%-35% aged 71-75 years, ⑤less than 10% aged 76-80 years.
(2) Sample size estimation
After scientific calculations, combined with the actual work, a total of 888 people
are needed for this project, then each group needs a sample size of n=111, and a total of
37 people are recruited in each street (town). The sample size calculation process is as
follows:
This study uses the dichotomous variable "whether a fall occurs" as the outcome
indicator. According to the results of the occurrence of falls among the elderly in the
community in Guangzhou City in 2023, the incidence of falls among the elderly in
Baiyun District was 17%. After discussion with experts, it was concluded that a 35%
reduction in the incidence of falls after the intervention was considered to be of public
health significance. In this study, the test level was set at α=0.05 and the test efficacy at
0.8 (i.e., β=0.2). The proposed factorial design for this study is based on the sample size
formula (below) for factorial designs in which the outcome variable is a dichotomous
variable, and the sample size required for each test condition can be obtained as:

9
n=
(�1−�/2+�1−�)2
2�[������(
�+��
2 )−������(
�−��
2 )]2 ≈83
�=0.17, �=0.35, �1−�/2=1.96, �1−�=0.84, k=3.
The total sample size required for the 8 test conditions was:
Nconditions = 83×8=664
According to S. Bhasin, T.M et al, the design effect of whole cluster randomisation
can be obtained by estimating ICC = 0.0076 and mean number of individuals in the
cluster m = 28:
DE= 1+（m-1）×ICC=1+（28-1）× 0.0076=1.2052
The sample size was set to be the same for the eight test conditions, and the total
sample size required for the study was:
N= �����������× DE ÷ 1 −10% ≈888
The required sample size for each test condition was then 111 cases;
Each of the 24 streets recruited 37 study participants.
(3) Intervention groups
The study subjects were grouped in a completely randomised manner, with a
statistician independent of the research team using a computer to generate random
numbers, and equal proportions of the study subjects recruited from the 24 streets (towns)
were allocated to the 8 experimental condition groups, so that each experimental
condition contained all the study subjects from 3 streets (towns). After grouping was
completed, a database of basic information about the study participants was created, as
shown in Table 1.This study was blinded only to the data collectors and data analysers.

10
Table 1 Subgroups of the Community Falls Prevention for Older People Pilot Project
groups
Fall Prevention
Education Course
Development of
personal exercise skills
Environmental
assessment
Group 1
Yes
Yes
Yes
Group 2
Yes
Yes
No
Group 3
Yes
No
Yes
Group 4
Yes
No
No
Group 5
No
No
No
Group 6
No
Yes
Yes
Group 7
No
Yes
No
Group 8
No
No
Yes
IV. Intervention Strategies
(1) Strategy 1: Falls prevention education programme
To organise the research subjects in the intervention group to set up a fall prevention
health education activity group, in which the project team will disseminate knowledge
and concepts of fall prevention through lectures, discussions, questions and answers, and
sharing, so as to enhance the knowledge base required by the research subjects to prevent
falls and to cultivate the relevant concepts.
(2) Strategy 2: Developing personal exercise skills
Through lectures, demonstrations, on-site exercises and practices, the project team
taught the intervention group participants to improve their balance function, lower limb
muscle strength, endurance exercise and other fall prevention exercise skills, and to use
fall prevention aids through group activities.

11
(3) Strategy 3: Environmental Assessment
Through the staff's home assessment and guidance, the project team instructed the
study participants to assess the risk factors of fall-related home environment and made
suggestions for modification.
V. Main intervention activities
(1) Strategy 1: Fall prevention education programme:
1.1 Frequency of intervention
4 times
1.2 Duration and intensity of intervention
60 minutes/time, once in each of the 1st, 3rd, 5th and 8th weeks of the intervention
period.
1.3 Intervention format
group intervention, 12 people in a group (in principle, no more than 15 people).
1.4 Intervention content
The content of health education includes (1) fall risk and preventability in the
elderly
(2)
improving
the
home
environment
to
prevent
falls
(3)
identifying
environmental risk factors in the community and public places (4) changing fall-prone
behaviours.
See Table 2 for specific content.

12
1.5 Intervention tool
accompanying teaching materials (PPT)
1.6 Intervention providers
the intervention was completed by trained staff of the community health service
centres in the project area, with at least two staff members required in each community,
one staff member acting as the health education activity group leader, who was mainly
responsible for organising and implementing each health education group activity
(lecturing, organising discussions, teaching exercise movements, answering questions
from the study participants, and generally arranging the group's activities); the other staff
member As an assistant, the other staff member worked with the group leader to
implement the group activities, and visited and protected the study participants during the
exercise period.
(2) Strategy 2: Development of individual exercise skills:
2.1 Frequency of intervention
4 times
2.2 Duration and intensity of intervention
30 minutes/time, once in each of the 1st, 3rd, 5th and 8th weeks of the intervention
period.
2.3 Intervention format
group intervention, 12 people in a group (in principle, no more than 15 people).

13
2.4 Intervention content
The content of health education included (1) basic knowledge of exercise safety, 4
methods of balance function exercise (2) review of 4 methods of balance function
exercise (3) methods of exercising muscle strength (4) 2 methods of endurance exercise.
See Table 3 for specific content.
2.5 Intervention tool
accompanying teaching text (PPT)
2.6 Intervention providers:
same as before.
Table 2 Time, frequency and main content of the implementation of the 4 fall
prevention education courses
Number of group
activities
intervention
time
Key knowledge skills
First time
Week 1
Fall risk and preventability in the elderly
Second time
Week 3
Improving the home environment to prevent falls
Third time
Week 5
Identify
environmental
risk
factors
in
communities and public places
Fourth time
Week 8
Change behaviours that predispose to falls.
Reviewing skills and exercises that have already
been learnt
Table 3
Time, frequency, and main content of 4 development of individual exercise
skills
Number of group
activities
intervention
time
Key knowledge skills

14
(3) Strategy 3: Environmental assessment
3.1 Duration and intensity of intervention:
The integrated intervention group and the environmental intervention group
community implemented 1 home falls environmental risk factor assessment and
modification guidance for the intervention group study participants in the 6th week after
the start of the health education group activities.
3.2 Intervention method, intervention content and intervention tools:
3.2.1 Intervention content
①Assessment of environmental risk factors for falls in the indoor environment of
the homes, hallways, or courtyards where the elderly people live on a daily basis;
②Provide in-person guidance on the environmental risk factors found and fill out
two written environmental assessment and modification recommendations, one to be
filled out by the investigator and then filed and entered; the other record to be left for the
use of the respondents;
③Provide at least the services of a night light, bathroom non-slip mats, fall
prevention warning signs, and double-sided adhesive fixed carpet floor mats. Conditional
areas are encouraged to provide more retrofitting services.
First time
Week 1
Basic knowledge of exercise safety
4 methods of exercising balance function
Second time
Week 3
Reviewing learned exercise methods
4 methods of exercising balance function
Third time
Week 5
Reviewing learned exercise methods
3 ways to build muscle strength
Fourth time
Week 8
2 endurance exercise methods
Reviewing learned exercise methods

15
3.2.2 Intervention Methods
After making an appointment, the project staff will enter the households at the
agreed time to conduct fall risk assessment of the study subject families in the
intervention group.
3.2.3 Intervention Tools
When carrying out the guidance on assessing the risk factors for falls in the home
environment, project staff mainly used the "Risk Factors for Falls in the Home
Environment of the Elderly and Suggestions for Retrofitting" (Appendix 4) to carry out
the assessment on an article-by-article basis and to provide suggestions for retrofitting.
Other intervention tools included night lights, non-slip mats, fall prevention warning
signs, double-sided tape, and other tools.
3.3 Intervention providers
Trained project community social workers or CHC staff.
3.4 Implementation Records
When carrying out the home environment risk assessment, with the consent of the
study participants, record the time of the assessment, the participants, the assessment
process, the assessment results, and the guidance suggestions using pictures, videos, and
words, and fill in the "Record of Home Environment Assessment and Improvement
Form" (Appendix 8); special attention is paid to the collection of comparisons before and
after the environmental modification.
VI. Project evaluation
Project evaluation includes baseline survey evaluation, effectiveness evaluation and

16
economics evaluation.
(1) Baseline survey assessment
1.1 Pre-intervention status of research subjects (baseline survey)
1.1.1 Implementation time
May 2024-June 2024.
1.1.2 Subjects of the survey
All older adults in the 8 study groups.
1.2 Baseline survey assessment content
1.2.1 Basic demographic information
Name,
gender,
age,
address,
contact
information,
ethnicity,
cohabitation,
occupational status, and education level.
1.2.2 Physical activity
Daily physical activity.
1.2.3 Illness and medication status
Type and number of illnesses, type and number of medications.
1.2.4 Falls-related information
Specific information on the occurrence of falls in the past year, fall effectiveness
level.
1.2.5 Assessment methods and tools
①Assessment methods
Questionnaire survey, on-site observation and other methods are selected according

17
to different assessment contents.
②Assessment tools
Self-administered questionnaire: basic demographic information, physical
activity, illness and medication use, and occurrence of falls (occurrence of falls in the last
year);
Established scale measurements: Falls Effectiveness Scale for the Elderly,
Quality of Life Scale.
See Annex 5 for specific assessment methods and tools.
Table 4 List of project baseline survey and assessment contents, methods and tools
Content
Method
Tool
classification
item
Basic demographic
information
Name, sex, age, address, contact
details,
ethnicity,
level
of
education, living with the family,
occupational status
Survey
Annex 5: Survey Asse
ssment Form (Part I)
Illness, Medication
and Medical
conditions
Type and number of illnesses,
type and number of medicines
used
Survey
Annex 5: Survey Asse
ssment Form (Part II)
Information about
falls
Incidents of falls, history of falls
Survey
Annex 5: Survey Asse
ssment Form (Part III)
Falls
Related
Knowledge,
Attitude and Action
Survey
Annex 5: Survey Asse
ssment Form (Part IV)
Falls efficacy
Scale
Annex 5: Survey Asse
ssment Form (Part V)
Quality of Life Scale
Capacity for daily living
Scale
Annex 5: Survey Asse
ssment Form (Part VI)
Gait
"Stand-up-and-walk" timing test
on-site test
Annex 5: Survey Asse
ssment Form (Part VI
I)
1.2.6 Main Evaluation Indicators
①Indicators reflecting the occurrence of falls: rate of people falling (number), rate
of people falling (number), rate of people falling (number), rate of people falling

18
(number), rate of people falling (number), and rate of people falling (number).
The rate of people falling (number), the rate of people falling (number), the rate of
people falling (number), the rate of people falling (number).
②Reflecting the effectiveness of falls: the score of the Falls Effectiveness
Assessment Scale.
③Reflecting the ability to perform daily living tasks: score on the Quality of Life
Scale.
(2) Process evaluation (intervention phase)
2.1 Evaluation time
May 2024-November 2024 (the whole process of project implementation)
2.2 Assessment Objects
Research subjects, project team staff.
2.3 Assessment contents and methods
2.3.1 Completion of group activities of research subjects
Evaluation of group activity attainment. The intervention team calculates the group
activity attendance rate of the research subjects based on their attendance in the group
activity record (number of research subjects who actually participated and completed the
current group activity/number of research subjects who should have participated in the
current group activity × 100%). The record form is shown in Appendix 3, "Record Form
of Research Subjects' Participation in the Project Process".

19
2.3.2 Quality of the organisation and implementation of intervention activities
On-site assessment team of CDC institutions at municipal and district levels,
selecting at least 30% of group activities for on-site quality assessment (on-site listening),
required to cover all 4 activities and at least 50% of intervention communities, focusing
on understanding the quality of the implementation of group activities and the learning
effect of the elderly. The on-site assessment should cover all intervention groups. For
details of the recording tool, please refer to Annex 6 "On-site quality assessment form for
group activities
2.3.3 Satisfaction of study participants with group activities
①Groups 1, 2, 3, 4, 6 and 7 Intervention Communities Each community, after
completing the health education group activities, organises a satisfaction survey and
group interviews with the study participants to find out the satisfaction, feelings and
suggestions of the study participants in participating in the group activities. For details of
the recording tools, see Annex 7, "Intervention Participants' Satisfaction Survey Form
(Elderly)".
②After the completion of household environmental assessment, guidance and
improvement in the intervention community, ask for their satisfaction and record it in
Annex 8, "Record Sheet for Household Environmental Assessment and Improvement
Guidance".
2.3.4 Household guidance and assistance in environmental improvement
Evaluate the implementation of guidance and assistance in completing the
environmental modification of household risk factors for study participants who have
been admitted to households. Based on the record of household visits, calculate the
completion rate of household guidance and assistance in environmental modification

20
(number of households actually visited and completed guidance and assistance in
environmental modification / number of households that should be visited for guidance
and assistance in environmental modification x 100%). For the record sheet, please refer
to Annex 8 "Record Sheet for Household Environmental Assessment and Improvement
Guidance Work".
2.4 Assessment Tools
Different assessment tools such as observation record sheets, questionnaires,
interview outlines, etc. were selected and used according to the different contents and
methods of the process assessment, as detailed in Table 5.
Table 5 List of project process evaluation contents, methods and tools
Content
Subject
Method
Tool
1. Completion rate of
group
activities
by
study participants
Study subjects in the
intervention group
on-site observation
Record of Participation of Research
Subjects in the Project Process
(Annex 3)
2.
Quality
of
the
organisation
and
implementation of the
intervention
Implementation team
activities staff
on-site observation
Panel activity site quality assessment
form (annex 6)
3. Satisfaction of study
participants
with
group activities
Study subjects in the
intervention group
Survey
Project Activity Satisfaction
Questionnaire (Elderly) (Annex 7)
4. Household guidance
and
assistance
in
environmental
rehabilitation
Staff implementing guidance
on environmental
improvements to households
Summary of work
records
Household
Environmental
Assessment
and
Improvement
Guidance Record Sheet (Annex 8)
(3) Assessment of effects
It is proposed to study the effect of the intervention at 6 and 12 months after the
start of the intervention. The assessment of the occurrence of falls will be collected by
filling in the monthly fall calendar; the changes in fall efficacy, knowledge, beliefs and

21
behaviours will be collected through on-site survey and testing.
3.1 Data collection on the occurrence of falls in the study population
3.1.1Assessment subjects
All study subjects in the 8 study groups.
3.1.2 Assessment period
From May 2024 to May 2025, information on the occurrence of falls was collected
on a monthly basis during the period from the start of the intervention to the completion
of 12 months of the intervention.
3.1.3Assessment content
Basic information on the occurrence of falls, with the same content as the baseline
survey and assessment.
3.1.4 Assessment methods and tools
①Study participants use the Monthly Record of Falls Occurrence Calendar
(Appendix 9) to record whether a fall has occurred or not.
Staff collected the Monthly Falls Record Calendar on a monthly basis, and used the
Baseline Survey Questionnaire on the Occurrence of Falls among the Elderly (Annex 5,
Part III) to conduct a detailed investigation on the time of falls that occurred.

22
3.2 First Effectiveness Assessment (after the start of the first intervention, at
the completion of 6 months)
3.2.1 Subjects of assessment
All study subjects in the 8 study groups.
3.2.2 Assessment time
The assessment time for the study subjects should be from the first implementation
of the intervention activities, when 6 months are completed (the control assessment time
is within ± 7 days) to implement the first effect assessment.
3.2.3 Assessment content
The content of the assessment includes: fall-related knowledge, attitude and
behaviour, daily life ability and fall efficacy.
3.2.4 Assessment methods and tools
The same assessment methods and tools as the baseline survey (Annex 5, Part IV,
Part V and Part VI).
3.3 Second Effectiveness Assessment (at 12 months after the commencement of
the first intervention)
3.3.1 Subjects to be assessed
All study subjects in the 8 study groups.

23
3.3.2 Assessment time
The assessment time for the study subjects should be from the first implementation
of the intervention activities, when 12 months are completed (the control assessment time
is within ± 7 days) to implement the second effect assessment.
3.3.3 Assessment content
The content of the assessment includes: the same as the baseline survey ("Annex 5,
Part III, Falls" does not need to be surveyed).
3.3.4 Assessment methods and tools
The same assessment methods and tools as the baseline survey.
(4) Economics Evaluation
Targeted cost-effect and cost-utility analyses from a social perspective will help
evaluate the real effects of the interventions in preventing falls in old age, and provide a
data basis for the governmental decision-making authorities to formulate reasonable
intervention policies.
4.1 Municipal Project Office
4.1.1Collection time
After 6 months of intervention (after the end of the 6-month evaluation) and 12
months (after the end of the 12-month evaluation).
4.1.2 Collection content
The municipal project office intervention cost collection mainly includes the direct

24
costs and time invested to carry out the falls intervention programme. Direct costs mainly
include travel costs for training, venue costs, expert costs, programme and manual
production costs, and survey tool costs. The time invested in carrying out the falls
intervention project includes the time invested by the municipal project office in
designing and preparing the project, initiating and managing the project, carrying out the
first level of training, attending the second level of training, and supervising the work.
4.1.3 Collection method
The main person in charge of the project in the municipal project office will fill in
the "Questionnaire on Workload and Cost Expenditure of Falls Intervention Project for
the Elderly in the Municipal Project Office" (Appendix 10) on his/her own, taking into
account the details of the financial expenditures.
4.2 District-level project offices
4.2.1 Collection time
Intervention full 6 months (6 months after the end of the assessment) and 12 months
(12 months after the end of the assessment).
4.2.2 Collection of content
The district-level project office intervention cost collection mainly includes the
direct cost of expenditure and time invested to carry out the falls intervention programme.
Direct costs include questionnaires, measurement tools, home environment improvement
supplies, and labour costs. The time invested in carrying out the falls intervention
programme includes the time invested in attending the primary training, carrying out the
secondary training, recruiting/screening older people in the community, conducting the
baseline survey, implementing the intervention, evaluating the process, and evaluating
the effects.

25
4.2.3 Method of collection
The main person in charge of the project in the district-level project office will fill in
the "Questionnaire on Workload and Cost Expenditure of Elderly Falls Intervention
Project in District-level Project Office" (Annex 11) by himself/herself in conjunction
with the breakdown of financial expenditure.
4.3 Primary health care institutions
4.3.1 Collection time
Intervention full 6 months (6 months after the end of the assessment) and 12 months
(12 months after the end of the assessment).
4.3.2 Collection content
The primary project office intervention cost collection mainly includes the direct
cost of expenditure and time invested in carrying out the falls intervention programme.
Direct costs mainly include printing questionnaires, purchasing measurement tools and
supplies for home environment improvement, and labour costs. The time invested in the
falls intervention programme included the time invested in attending Level 1 and Level 2
trainings, recruiting/screening older people in the community, conducting baseline
surveys, implementing interventions, and evaluating outcomes.
4.3.3 Method of collection
The main person in charge of the project in the grassroots project office, together
with the breakdown of financial expenditure, filled in the "Questionnaire on Workload
and Cost Expenditure of Falls Intervention Programme for the Elderly in the Grassroots
Project Office" on his/her own (Annex 12).

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4.4 Collection of Costs Related to Research Subjects
4.4.1 Collection time
From the beginning of the intervention to the end of the endline assessment,
collected on a monthly basis (accompanied by a monthly calendar of falls).
4.4.2 Collection content
Costs related to falls of the study participants mainly include outpatient/emergency
room visits, hospitalisation costs, drug costs, nutritional costs, home care and carer/nanny
costs due to falls during the project period.
4.4.3 Collection method
The staff of the grassroots project office used the "Questionnaire on Falls-Related
Expenses during the Intervention Period of the Study Subjects" (Appendix 13), which
was obtained through face-to-face surveys, combined with the data from the elderly's
medical expenditure records and financial documents.
As different types of expenses may be incurred by a particular fall of the study
participant, when completing the "Questionnaire on Falls-related Expenses during the
Intervention Period of the Study Participants" (Annex 13), staff members filled in the
corresponding questionnaire in Annex 13 according to the different treatments actually
incurred by the study participant. Possible treatment situations include self-treatment
(Part I of Annex 13), outpatient emergency visit (Part II of Annex 13), inpatient treatment
(Part III of Annex 13), out-of-hospital rehabilitation treatment (Part IV of Annex 13), and
review (Part V of Annex 13). In case of inpatient treatment for study subjects, the final
cost was entered at the time of discharge. The information collected is not duplicated
with that collected in the previous month. If the study participant had rehabilitation
treatment, rehabilitation in outpatient emergency clinic was counted in the outpatient

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emergency clinic fee schedule (Annex 13 Part II), rehabilitation during inpatient
hospitalisation was counted in the total inpatient hospitalisation fee (Annex 13 Part III),
and out-of-hospital rehabilitation was counted in the out-of-hospital rehabilitation fee
(Annex 13 Part IV).
VII. Methods of Statistical Analysis
(1) Data collection
The collection and management of all research data will be done relying on the
REDCap platform. After the formation of the preliminary database, the database will be
checked and cleaned again for logical errors and missing values, and the database will be
finally formed after further verification and correction by telephone follow-up with the
respondents.
(2) Data collation and analysis
SPSS20.0 was used for statistical processing. Variables such as general demographic
characteristics, disease characteristics, previous falls, and level of social support at
baseline were compared to see if there were any differences between the different
intervention groups, and variables with differences would be corrected in the subsequent
analyses. Intent-to-treat (ITT) analysis is proposed to evaluate the intervention in this
study. Descriptive analysis: statistical descriptions of primary outcome variables,
secondary outcome variables, intervention implementation and other synergistic factors,
etc., and independent samples t-tests (continuous variables such as Older Adult Falls
Efficacy Scale scores, Quality of Life Scale scores, Older Adults' Falls Knowledge and
Belief Behaviour Scale scores, etc.) and chi-square tests (categorical variables such as
attitudes towards the intervention strategy, incidence of falls, etc.) to compare the
between-groups differences were used.

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The
study
proposes
to
assess
the
economic
benefits
using
Incremental
Cost-Effectiveness Ratio (ICER), which is the increased cost per unit of effect.

29
VIII. Safety Guarantee
(1) When carrying out the various screening, assessment, training, exercise and
other activities of the project, the safety and physical health of the research subjects
should be ensured as the first principle.
(2) During the various screening and assessment processes, research subjects should
be clearly informed of the testing methods and possible risks. The project may conduct
demonstrations
and
allow
research
subjects
to
practise
before
taking
formal
measurements. The staff should remind the participants that they should not pursue
"good results" in the test.
(3) In the process of training and exercise, the basic principles are gradual and
according to one's ability, and research subjects should not be forced to perform
movements that are beyond their ability. All exercises are subject to the subjective feeling
of the research subjects themselves, while attention should be paid to correcting the
research subjects' sense of "not obeying the old" and stopping dangerous actions in time.
(4) When carrying out the assessment activities, the staff should clean up the risk
factors in the environment beforehand, removing slippery ground, unevenness, obstacles
and other environmental risk factors that may cause injuries to the research subjects.
Seats or similar facilities for research subjects to rest should also be provided.
(5) Staff should prepare first-aid medication and related equipment at all project
sites, and staff who can administer primary first aid should be present at each site.

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IX. Quality control
(1) Quality control of the process of formulating and developing the project
programme and related intervention tools
At different stages, through the organisation of experts in different fields, work
programmes such as the overall project programme, the survey and assessment
programme, and the intervention implementation programme; the design and use of
questionnaires, checklists and record forms for various types of surveys and assessments;
and the content and form of interventions are validated.
(2) Quality control of data collection
2.1 Unify tools and methods
Unify survey, measurement and assessment methods and tools.
2.2 Training
Conduct unified training and assessment for researchers participating in data
collection regarding the use of work programmes, techniques and tools related to
assessment information collection. They will be allowed to work only after passing the
assessment.
2.3 On-site verification of data collection
All surveys, measurements and assessment work must be carried out at the site for
corresponding verification and quality control. Mainly includes on-site verification of
questionnaires and measurement items. Some of the research subjects are taken to repeat

31
the measurements. For details of the specific methods, please refer to the Requirements
for On-site Quality Control Work of Survey and Evaluation (Annex 15).
2.4 Data entry and cleaning
According to the questionnaire or form, create and use REDCap to establish a
unified entry file and set up preliminary logical calibration. Randomly select more than
20% of the entered questionnaires for secondary calibration to ensure the quality of data
entry. Establish uniform data cleaning regulations and document the data cleaning
process.
(3) Quality control of the implementation of intervention group activities
3.1 Unify the content, methods and tools of group activities.
Develop a unified programme of group activities and use unified training manuals
and tools.
3.2 Training and evaluation of group activity implementers
Organise certified training of trainers (team leaders and assistants) to implement
intervention group activities. They will pass the unified standardised training, practice
and assessment, and will only be allowed to work after passing the assessment.
3.3 On-site evaluation of the quality of intervention group activities
On-site evaluation teams from CDC agencies at the city and district levels conduct
on-site quality assessment of group activities. See the process evaluation section for
details.

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(4) Management of lost visitors
4.1 Definition of lost visitors:
Lost visitors were defined in this study as 1) study participants who explicitly
refused to continue with the intervention via text message, WeChat applet, or phone call;
and 2) withdrawal from the study due to the occurrence of an adverse health outcome,
including hospitalisation for somatic or psychological illnesses, etc. Hospitalisation of
study subjects due to unintentional injuries was not used as a criterion for study subject
withdrawal from the study, but was recorded as a health outcome.
4.2 Controlling for loss of study subjects
4.2.1 Incentive
During the implementation of the project, each community health service centre will
make use of local resources and advantages to provide certain free medical and health
services (not related to fall prevention) or a certain degree of material incentives, to
continuously maintain contact and communication with the study subjects, and to
encourage the study subjects to participate in the project-related interventions,
assessments, and monitoring activities.
4.2.2 Follow-up Confirmation
At least once a month, project staff will conduct a follow-up visit and communicate
with the research subjects by phone, in-home or face-to-face to confirm that the research
subjects are not missing, encourage the research subjects to continue to participate in the
activities, and record the follow-up information in the "Record of Follow-up Visits to
Research Subjects" (Annex 16).

33
4.2.3 Using project activities to understand absenteeism
During the group activities of each group, when reporting the monthly report card
on falls, and during the regular evaluation of the effectiveness of the project, when there
are cases of non-participants who should have participated in the activities, we should go
to the households or make phone calls to find out the reasons for the absences, and
whether they are able to continue to participate in the project, so as to encourage the
research subjects to persist in participating in the follow-up activities of the project.
4.3 Management of lost visitors
In the event of a missed visit, the reasons for the participant's withdrawal from the
study will be recorded in detail in the "Record of Participation of Research Subjects in
the Project Process" (Attachment 3), and an evaluation of the effectiveness of the project
will be carried out as far as possible according to the actual situation.
4.4. Monthly Reporting System of Research Subjects' Information
Report the participation of research subjects in intervention activities and loss of
visits in the four research groups on a monthly basis.
(5) Control of pollution
5.1 Avoid the influence of other projects
During the intervention period the project community tries not to participate in other
similar studies and projects that may affect the intervention effect. And record the
implementation of all relevant projects in the project community during the intervention
period.

34
5.2 Handling of contamination between research groups
Obedience to the project programme, the research subjects between the groups will
not participate in the activities of other groups for any reason during the intervention
period. Once appeared should be stopped immediately and recorded truthfully.
(6) Concealment of research subjects' groups
Study subjects were not grouped during the recruitment stage to avoid possible bias.
(7) Blinding
7.1 Establishing an independent assessment work team
An independent evaluation work team is set up to implement the baseline survey
and effect evaluation (including the monthly report survey on the occurrence of falls).
The composition of the assessment team should exclude the staff implementing the
intervention. The evaluation site should not reveal information about the group of study
participants and ensure that the evaluators do not know the group of study participants.
At a minimum, the independent assessment team should assess fall occurrence, gait and
fall effectiveness.
7.2 Hidden group information in the database
Groups are coded in the database using group codes that are not recognisable to
analysts, ensuring that data analysts do not know which intervention group the study
participant is in by using the group information in the database.

35
X. Research flow chart
Figure 1 Project Flowchart
Note: Work completed in yellow

36
XI. Organisational management and division of responsibilities
(1) Guangzhou Centre for Disease Control and Prevention
Overall responsible for the project work, formulate the work plan, organise expert
demonstration, pre-test, organise the implementation of intervention, evaluation and
summary. It is responsible for conducting first-level training, overall implementation of
quality control work, and work supervision. According to the project programme, select
the project site area and clarify the division of responsibilities among the cooperation
units. Responsible for coordinating the cooperation units in the district, carrying out
training, implementing interventions, implementing quality control work requirements,
guiding the implementation of evaluation and other work, and organising work
supervision.
(2) CDC of the project site area
According to the project programme, it is responsible for implementing and
coordinating the project communities/sections to carry out intervention activities,
implementing training, assessment, quality control, and daily management of the project.
(3) Community Health Service Centre of the project site
Organise and implement the project work in the district and implement the quality
control requirements.

Pilot Project on Prevention of Falls among Community-dwelling Elderly in
Guangzhou
Informed Consent Form (Group 1)
Dear Elderly Friend, Hello!
Before you decide to participate in this study, we would like to explain to you the purpose of
the study, the possible risks and benefits. Your decision to participate or to withdraw from the
study is completely voluntary.
Falls are a major health threat to older people, seriously affecting their health and quality of
life. Domestic and international evidence shows that falls in the elderly can be effectively
prevented through the use of scientific preventive measures. This study was conducted to
determine the effectiveness of the intervention of a pilot project to prevent falls in older adults in
Guangzhou. This study was conducted by the Guangzhou Municipal Centre for Disease Control
and Prevention (GZCDC), the Baiyun District CDC, and the _________ Community Health
Service Centre, and the person in charge of this study is Dr Liang Boheng, Chief Physician of the
GZCDC.
If you agree to participate in this project, you will be assigned to one of the following study
groups and will participate in related project activities.
You will participate in the following: ①Fall prevention education programme. The main
content is to organise regular fall prevention health education courses to learn about fall
prevention. ②Exercise programme, the main content is to help the study participants to learn fall
prevention exercise skills and use fall prevention related aids. ③Environmental assessment, the
main content of the door-to-door assessment of environmental risk factors for falls.
In addition, you need to receive regular survey assessments. The main content is to
understand your basic information, illness and medication, daily physical activity, fall-related
information and balance function through questionnaires and test assessments. A survey and
assessment takes about 20-30 minutes to complete. The project as a whole requires a total of two
surveys and assessments at 6 months and 12 months after the start of the project.
To organise health education group activities, we will provide the venue and conditions for
learning, provide learning materials, fall recording tools, provide professionals to teach the
knowledge and conduct guidance on exercise and environmental inspection. Exercises included
in the group programme are safe, fitness-oriented and do not cause any health damage, and the
risk is no greater than that of daily activities. Medicines and first-aid equipment and medical staff
were provided during the assessment and exercise sessions so that emergencies could be dealt
with in a timely manner.
During the survey, assessment and intervention, trained staff will complete the survey,

testing and guidance. They will explain every question to you in order to eliminate your doubts.
The costs incurred in the survey and evaluation activities related to this project will be borne by
the project. In addition, the project will keep all information that may involve the privacy of you
and your family members in strict confidentiality; data entry will be recorded using coded
identifiers to record information, and your name and identity will not be displayed; when the
results are released, only the results of the group survey will be reported, and there will not be
any results related to individuals, so that the risk of information leakage will be minimised as
much as possible through these measures. During the course of the study, if you agree to take part
in the study, the results of medical examinations related to your health will be fed back to you
directly and further health counselling will be provided to you. In the event of an injury such as a
fall due to other unforeseen reasons, we can provide you with counselling services. Of course,
you also have the right to refuse to participate or withdraw from the study at any point in time,
and your rights will not be affected in any way.
This project is a public welfare project, and there is no remuneration or compensation for
your participation in this project. However, your participation will enable us to better understand
the effectiveness of the interventions of the pilot project on prevention of falls among the elderly
in Guangzhou City, so that we can provide support for the prevention of falls among the elderly
in Guangzhou City. Therefore, we sincerely hope that this study will receive your strong support
and co-operation!
If you have any health related questions and suggestions, please ask and we will try our best
to help, you can also contact our survey office directly.
Contact: Huang Ting Yuan
Tel: 36052333-1610
-----------------------------------------------------------------------------------------------------------
Informed Consent Statement:
I have read this informed consent form and know the purpose of the study, the steps of
implementation, and the risks and benefits, and all questions have been addressed.
My choice is: I voluntarily □agree, □do not agree to participate in this survey.
Subject's name (signature):
Date:
I have explained the purpose of the study to all subjects and have answered all of the

subjects' questions. It is my understanding that the subject is aware of the purpose, process, risks
and benefits of the study.
Name of staff member who obtained informed consent (signature):
Date: