Research Article: Individually-tailored multifactorial intervention to reduce falls in the Malaysian Falls Assessment and Intervention Trial (MyFAIT): A randomized controlled trial

Date Published: August 3, 2018

Publisher: Public Library of Science

Author(s): Pey June Tan, Ee Ming Khoo, Karuthan Chinna, Nor I’zzati Saedon, Mohd Idzwan Zakaria, Ahmad Zulkarnain Ahmad Zahedi, Norlina Ramli, Nurliza Khalidin, Mazlina Mazlan, Kok Han Chee, Imran Zainal Abidin, Nemala Nalathamby, Sumaiyah Mat, Mohamad Hasif Jaafar, Hui Min Khor, Norfazilah Mohamad Khannas, Lokman Abdul Majid, Kit Mun Tan, Ai-Vyrn Chin, Shahrul Bahyah Kamaruzzaman, Philip Poi, Karen Morgan, Keith D. Hill, Lynette MacKenzie, Maw Pin Tan, Terence J. Quinn.

http://doi.org/10.1371/journal.pone.0199219

Abstract

To determine the effectiveness of an individually-tailored multifactorial intervention in reducing falls among at risk older adult fallers in a multi-ethnic, middle-income nation in South-East Asia.

Pragmatic, randomized-controlled trial.

Emergency room, medical outpatient and primary care clinic in a teaching hospital in Kuala Lumpur, Malaysia.

Individuals aged 65 years and above with two or more falls or one injurious fall in the past 12 months.

Individually-tailored interventions, included a modified Otago exercise programme, HOMEFAST home hazards modification, visual intervention, cardiovascular intervention, medication review and falls education, was compared against a control group involving conventional treatment.

The primary outcome was any fall recurrence at 12-month follow-up. Secondary outcomes were rate of fall and time to first fall.

Two hundred and sixty-eight participants (mean age 75.3 ±7.2 SD years, 67% women) were randomized to multifactorial intervention (n = 134) or convention treatment (n = 134). All participants in the intervention group received medication review and falls education, 92 (68%) were prescribed Otago exercises, 86 (64%) visual intervention, 64 (47%) home hazards modification and 51 (38%) cardiovascular intervention. Fall recurrence did not differ between intervention and control groups at 12-months [Risk Ratio, RR = 1.037 (95% CI 0.613–1.753)]. Rate of fall [RR = 1.155 (95% CI 0.846–1.576], time to first fall [Hazard Ratio, HR = 0.948 (95% CI 0.782–1.522)] and mortality rate [RR = 0.896 (95% CI 0.335–2.400)] did not differ between groups.

Individually-tailored multifactorial intervention was ineffective as a strategy to reduce falls. Future research efforts are now required to develop culturally-appropriate and affordable methods of addressing this increasingly prominent public health issue in middle-income nations.

ISRCTN Registry no. ISRCTN11674947

Partial Text

Asian nations and other developing countries worldwide currently experiencing population ageing at a faster rate than that experienced by North America and Western Europe in the previous century [1]. Falls in older persons will, therefore, inevitably pose a large and growing burden to healthcare services in these countries. Falls are common among older adults and are associated with adverse physical consequences including hip fractures, other major fractures and intracranial bleeding [2, 3]. Functional dependency and psychological consequences associated with falls such as depression and pathological fear-of-falling have also been observed after an index fall [4]. In addition, one in four older people who present to emergency services following a fall were found to be no longer alive after one year [5].

This was a pragmatic, parallel randomized-controlled trial using a simple randomization with a 1:1 allocation ratio. The study protocol has been registered as a clinical trial (clinical trial registration number: ISRCTN11674947) S1 Text and the full protocol is published elsewhere [16]. A brief description of the study protocol is provided here. The recruitment period was from 2012 to 2014, with the last participant’s follow-up visit occurring in February 2016. Recruitment was stopped once an adequate sample sizes was obtained. The study was approved by the local institutional review board, University of Malaya Medical Ethics Committee (ethics number 925.4), and written informed consent was obtained from all participants.

Two hundred and sixty-eight participants were recruited. Fig 1 presents the CONSORT flow diagram S2 Text, which describes the recruitment process, treatment allocation and attrition. The participants’ mean age was 75.3 (±7.2 SD) years and 67% (n = 176) were female. The ethnic distribution was 61% (n = 166) Chinese, 17% (n = 45) Malay, 19% (n = 51) Indian and 2% (n = 6) others. Table 1 summarizes the baseline characteristics of participants in both intervention and control groups. Among participants who were randomized to the intervention group, 92 (68%) were prescribed modified Otago exercises, 86 (64%) visual intervention, 64 (47%) home hazard modification and 51 (38%) cardiovascular interventions. Table 2 summarizes the list of probable risk factors identified following the initial assessment, prior to further home hazards evaluation using the HOMEFAST and confirmatory cardiovascular assessments.

This randomized-controlled study which compared individually-tailored multifactorial interventions to conventional treatment among older adults with recurrent or injurious falls in a middle-income, South-East Asian nation had found no difference in the fall recurrence, rate of fall and time to first fall between intervention and control groups at 12-month follow-up. This was a pragmatic study which uniquely evaluated a complex intervention in a developing country setting where the healthcare system remains hospital centric with minimal primary healthcare and community health support [35].

No reduction in fall recurrence, rate of fall or time to first fall were observed over a 12-month follow-up period in a randomized-controlled study comparing individually-tailored multifactorial interventions to conventional treatment as secondary falls prevention. Future studies should consider evaluating in greater detail, cultural differences in behaviour and outcomes following fall events, as well as identify culturally appropriate and affordable solutions for the management of high-risk fallers in lower and middle-income countries.

 

Source:

http://doi.org/10.1371/journal.pone.0199219

 

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