The Malaysian Falls Assessment and Intervention Trial
| ISRCTN | ISRCTN11674947 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11674947 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/10/2012
- Registration date
- 27/11/2012
- Last edited
- 06/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Department of Medicine
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia
 ORCID ID |
0000-0002-3400-8540 |
|---|
Study information
| Study design | Single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please contact Dr M P Tan, mptan@ummc.edu.my to request a patient information sheet |
| Scientific title | The Malaysian Falls Assessment and Intervention Trial: a randomized controlled trial |
| Study acronym | MyFAIT |
| Study objectives | Multifaceted interventions is effective in reducing falls in older Malaysians with a history of previous falls. |
| Ethics approval(s) | Medical Ethics Committee, University of Malaya Medical Centre, 20/06/2012, ref: 925.4 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2012 |
| Completion date | 02/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | 1. Individuals aged >65 years 2. Two or more falls or one injurious fall over the past 12 months |
| Key exclusion criteria | 1. Clinical diagnosis of dementia 2. Inability to stand |
| Date of first enrolment | 10/07/2012 |
| Date of final enrolment | 23/12/2014 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
50603
Malaysia
Sponsor information
University/education
c/o Prof Dato Ikram Shah bin Ismail
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Website | http://www.ummc.edu.my |
|---|---|
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Article has now been submitted for publication |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/06/2014 | Yes | No | |
| Other publications | secondary subgroup analysis | 01/03/2018 | Yes | No | |
| Results article | results | 03/08/2018 | Yes | No |
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.
