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
mptan@ummc.edu.my
Trial website
Contact information
Type
Scientific
Primary contact
Dr Maw Pin Tan
ORCID ID
http://orcid.org/0000-0002-3400-8540
Contact details
Department of Medicine
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The Malaysian Falls Assessment and Intervention Trial: a randomized controlled trial
Acronym
MyFAIT
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
Interventional
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, mptan@ummc.edu.my to request a patient information sheet
Condition
Falls in older people
Intervention
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
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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
01/07/2012
Overall trial end date
02/02/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Individuals aged >65 years
2. Two or more falls or one injurious fall over the past 12 months
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Clinical diagnosis of dementia
2. Inability to stand
Recruitment start date
10/07/2012
Recruitment end date
23/12/2014
Locations
Countries of recruitment
Malaysia
Trial participating centre
University of Malaya
Kuala Lumpur
50603
Malaysia
Sponsor information
Organisation
University of Malaya Medical Centre (Malaysia)
Sponsor details
c/o Prof Dato Ikram Shah bin Ismail
Lembah Pantai
Kuala Lumpur
59100
Malaysia
Sponsor type
University/education
Website
Funders
Funder type
University/education
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
government non-federal
Location
Malaysia
Results and Publications
Publication and dissemination plan
Article has now been submitted for publication
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24951180
2017 secondary subgroup analysis in: http://www.ncbi.nlm.nih.gov/pubmed/28827207
Publication citations
-
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.