Condition category
Injury, Occupational Diseases, Poisoning
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
About one in three older people over the age of 65 years fall at least once a year. Falling over often leads to loss of confidence and avoidance of activity. Some older people are admitted to nursing homes because of repeated falls. Falls can also lead to severe health problems which include fractures of the hip bone and bleeding in the brain. The older person often becomes very dependent suffering the above consequences. Falls in the older person tend to be due to a few problems rather than just one problem on its own. These problems include heart problems, low blood pressure, side-effects of medications, poor balance, muscle weakness, previous strokes, eyesight and the home environment. To treat falls in the older person, we need to look into the whole person and deal with all the potentially treatable causes. The aim of this study is to find out whether a treatment package which looks into treating multiple possible conditions that increase the risk of falls is an effective method of treating falls in the older population in Malaysia.

Who can participate?
Patients with one fall resulting in physical injuries or two or more falls over the past 12 months from the primary care clinic, geriatric clinic and Accident and Emergency.

What does the study involve?
The patients are approached by a researcher to find out if they are interested in the study. Those who agree to take part are then given an appointment to attend a falls clinic. At the falls clinic, patients are given a medical check-up to find out what may be causing them to fall. This involves taking a history, a physical examination, an ECG heart trace, blood pressure and eye tests. The doctor may also order some blood tests, X-rays and some other tests if required, and ask questions about the psychological effects of falls. After the medical check-up, patients are randomly allocated to one of two groups: the regular treatment or the active intervention group. The regular treatment group continue to receive the treatment planned by the doctors they first saw at the clinic or A&E. They are asked to fill in a falls diary and the researcher contacts them regularly over the next 12 months to find out how they are, and they will be seen again in 12 months for a check-up. If the patient is allocated to the active intervention group, they are given individually-tailored treatment, which is prescribed by the doctor. This can include changes to their medication, heart tests, physiotherapy, and a home visit. The doctor may also refer the patient to the heart specialist, eye specialist or ENT specialist. If the doctor finds that the patient has a balance problem, he/she is referred for physiotherapy, which involves exercises to strengthen his/her muscles. If the patient has a fall in their own home, an occupational therapist visits them at home to see if we can help make their home safer.

What are the possible benefits and risks of participating?
Participants receive a health check at no charge, and any medical problems identified during health screening are addressed as appropriate. There are no known risks associated with participating in this study.

Where is the study run from?
University of Malaya Medical Centre (Malaysia)

When is the study starting and how long is it expected to run for?
July 2012 to February 2016

Who is funding the study?
University of Malaya (Malaysia)

Who is the main contact?
Dr Maw Pin Tan

Trial website

Contact information



Primary contact

Dr Maw Pin Tan


Contact details

Department of Medicine
Faculty of Medicine
University of Malaya
Kuala Lumpur

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The Malaysian Falls Assessment and Intervention Trial: a randomized controlled trial



Study hypothesis

Multifaceted interventions is effective in reducing falls in older Malaysians with a history of previous falls.

Ethics approval

Medical Ethics Committee, University of Malaya Medical Centre, 20/06/2012, ref: 925.4

Study design

Single-centre randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please contact Dr M P Tan, to request a patient information sheet


Falls in older people


Individually-tailored, multifaceted interventions involving modifiable risk factors of falls:
1. Cardiovascular Assessment and Intervention
2. Medication Review
3. Physiotherapy Prescribed Strength and Balance Exercise Programme
4. Home-hazards Intervention
5. Visual assessment and intervention
6. Others- as required

Intervention type



Not Applicable

Drug names

Primary outcome measure

Fall recurrence over 12 months follow-up measured with a falls diary. Participants will also receive telephone interviews every 2 months to corroborate the accuracy of the diaries and to improve compliance.

Secondary outcome measures

Autonomic measures, gait and balance measures and psychological measures conducted on initial assessment. Follow up visits to be hospital will be conducted at 12 months.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Individuals aged >65 years
2. Two or more falls or one injurious fall over the past 12 months

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Clinical diagnosis of dementia
2. Inability to stand

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University of Malaya
Kuala Lumpur

Sponsor information


University of Malaya Medical Centre (Malaysia)

Sponsor details

c/o Prof Dato Ikram Shah bin Ismail
Lembah Pantai
Kuala Lumpur

Sponsor type




Funder type


Funder name

University of Malaya (Malaysia) ref: RP-010-2012

Alternative name(s)

University of Malaya, UM

Funding Body Type

government organisation

Funding Body Subtype

Local government



Results and Publications

Publication and dissemination plan

Article has now been submitted for publication

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

2014 protocol in:
2017 secondary subgroup analysis in:
2018 results in:

Publication citations

  1. Protocol

    Tan PJ, Khoo EM, Chinna K, Hill KD, Poi PJ, Tan MP, An individually-tailored multifactorial intervention program for older fallers in a middle-income developing country: Malaysian Falls Assessment and Intervention Trial (MyFAIT)., BMC Geriatr, 2014, 14, 78, doi: 10.1186/1471-2318-14-78.

Additional files

Editorial Notes

06/08/2018: Publication reference added. 19/10/2017: Publication reference added. 26/05/2017: The following changes were made to the trial record: 1. The overall trial start date was changed from 01/11/2012 to 01/07/2012. 2. The overall trial end date was changed from 30/06/2014 to 02/02/2016.