Study design and ethics
This feasibility study was an observational cohort study. Data protection and ethical approval were obtained from two institutional ethics review boards, Singapore Institute of Technology (reference number: 2019129) and Queen Margaret University (reference number: REP0197). This study conforms with the CONSORT extension to randomised pilot and feasibility trials, excluding specific items required for randomisation nature of the study [26] (Additional File 1).
Participants and Setting
Poster advertisement was circulated to the network of older adults engaged by Singapore Institute of Technology (SIT) for school assignments, residents’ network centres and various clinical partners across Singapore. Between September and October 2019, interested older adults contacted the researcher through the contact details listed in the posters or given through word-of-mouth recommendations. They were asked by a researcher whether they were aged 65 years or older, living in the community and were able to read, write and communicate in English before a meeting was arranged at SIT or an agreed location in Singapore. During the meeting, they were provided study information, e.g. how the study would be conducted, what will be expected of them, the study’s eligibility criteria (Table 1). They were informed that participation would be voluntary. If they did not meet the eligibility criteria, they were given general information about falls prevention. An opportunity to ask questions was offered, and the consent form was completed if they agree to participate. In line with good practice, participants were given SGD$50 as a thank you for taking part, reimbursing them for their time, contribution and any expenses incurred, e.g. sim-card cost, travelling cost. This was not used to induce participation in the study.
Table 1 Eligibility criteria
Inclusion Criteria
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Exclusion Criteria
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65-year-old and above
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Requiring any physical assistance from another person to walk within home
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Ability to read, write and communicate in English
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Known active malignant conditions
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History of at least one near-fall or one fall within the last 12 months
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Cardiovascular conditions, e.g. neurally mediated syncope, cardiac syncope, structural heart diseases, e.g. aortic stenosis or hospitalization for myocardial infarction or heart surgery within three months
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Living independently in the community with or without the use of a walking aid
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Pulmonary conditions, e.g. chronic severe obstructive pulmonary disease or oxygen dependence
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Not having any cognitive dysfunction by achieving a score of 7 or less in the 6-item cognitive impairment test (6CIT) [27]
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Musculoskeletal conditions, e.g. moderate to severe osteoarthritis that could affect balance control and muscle function, e.g. self-reported pain or dysfunction of the trunk and extremities, fractures or injuries in the extremities in the last six months.
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Able to walk 6 meters within 12 seconds by performing the Timed Up and Go (TUG) test [28]
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Neurological conditions, e.g. Parkinson’s Disease, sequelae of stroke, Amyotrophic Lateral Sclerosis, Multiple Sclerosis or severe Dementia or epilepsy
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Able to catch a 30cm ruler with each hand using the Hand Reaction Time (HRT) test [29]
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Legal blindness, severe visual impairment, severe hearing impairment or legal deafness
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Pilot sample size
Based on Ryan et al. [20] study, we estimated an 80% response rate and a 10% drop out rate for our research. We adopted a sample size of 30, which had been identified to be a reasonable number for a feasibility study [30]. A projected number of 630 responses (30 subjects for 21 days) was to be obtained throughout the research.
Data collection
The researcher completed the data collection with the participants using a standardised data extraction form to record demographic data (age, race, gender, educational level, housing type, living situation, personal mobility, falls history and near-fall history), cognitive functioning using the Six-item Cognitive Impairment Test (6CIT) [31], upper limb reaction function using the Hand Reaction Time Test (HRT) [29] and lower limb physical function using the Timed Up and Go Test (TUG) [28].
Cognitive functioning
The 6CIT is a brief and simple validated tool used for cognitive screening in the community-dwelling older adults [27]. Participants needed to complete three tests of temporal orientation (year; month; time), two tests of attention (counting backwards from 20 to 1; reciting the months of the year in reverse) and short-term memory (5-item address). The total score was recorded with higher scores indicating greater impairment.
Upper limb reaction function
The HRT [29] is a performance measure to determine whether the participant will be able to execute grasping manoeuvre quickly. A 30-centimetre ruler will be dropped between the participant’s thumb and index finger, with instructions to “catch” the ruler between the fingers as quickly as possible. The participant had to grip the ruler after it is dropped without letting the ruler landing on the floor. The test established whether the participants had adequate upper limb reaction ability.
Lower limb physical function
The TUG is a reliable and valid test for quantifying functional mobility in older adults [28]. Participants were timed to complete the task of raising from an armchair, walk 3 meters, then walk back at their normal pace to sit down in the armchair in a safe manner. The time taken to complete the task was recorded.
Key research outcomes
Briefing to explain a fall and near-fall
One primary outcome measure was to determine the feasibility of conducting a presentation to explain the different meanings between a near-fall and a fall to the community-dwelling older adults. Operational definitions of falls and near-falls were presented to the participants. These definitions were consistent to those in the literature using language and concepts that aimed to be clear, relevant and easily understandable by the older participants.
A fall definition was adopted, in concordance with the PROFANE-group consensus statement, as ‘an unexpected event in which the participant comes to rest on the ground, floor, or lower-level’ [15]. Explaining the concept of falls in a lay perspective to the participants included scenarios involving a slip or a trip or any event causing a loss of balance resulting the individual to land on a lower level including the floor, ground or furniture such as chair or bed. The participants were informed that intentional causes such as a deliberate push by another person or a medical occurrence such as heart attack, fainting, stroke, seizure were not considered as falls in the study.
Near-fall was defined as an event when the individual slips, trips, or loses balance but uses the hand(s) or leg(s) or any body part to recover balance and prevent a complete fall. This definition aimed to be relevant, comprehensive and understandable to the older participants. Participants were then presented with several scenarios (Table 2) and asked whether each scenario reflected a fall, a near-fall or no fall. If the participant identified the situation as a near-fall, then the researcher asked what balance recovery manoeuvre was used to prevent the fall. At the end of the briefing, the researcher ensured there were no further questions from the participants about differentiating a fall, near-fall or no fall event.
Table 2 Scenarios given to participants
1. Fall Scenario – The individual is walking along the street, trips over an object and loses balance. The individual landed on the floor.
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2. Fall Scenario – The individual is getting dressed by the bed, loses balance and lands on the bed.
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3. No Fall Scenario – The individual is walking across the room and starts to feel dizzy. The person sits on a nearby chair.
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4. No Fall Scenario – The individual is walking along the street and is deliberately pushed by another person to the ground.
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5. Near-Fall Scenario – The individual holds onto a rail after losing balance when the bus starts to move (hand strategy)
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6. Near-Fall Scenario – The individual stumbles while walking and can restore balance by taking a few steps (leg strategy)
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Collecting near-falls and falls data
After the briefing, the researcher obtained the preference of the participants’ mode of communication to report the incidence of near-fall, fall or no fall. Three options were provided: (1) a daily call or (2) a daily text or (3) either a daily call or text scheduled at a prearranged timing. There were no text reminders given during the day to avoid overburdening the participants. One scheduled text was sent each day, even if there was no text reply from the participant. For calling, a second call would be made an hour later of the scheduled timing if there was no response to the first call. No further calls were made if there was no response to the second call. Over the next 21-day, the participants were asked two questions by the researcher daily, “Have you fallen in the past 24 hours?” and “Have you almost fallen in the past 24 hours?” using the participant’s preferred mode of communication. If “yes” was replied to the near-fall question, the participants were asked, “Did you prevent the fall using your hands or legs or any body part?” The participants then identified the balance recovery manoeuvre used to prevent the fall. If “yes” was replied to the fall question, the researcher checked if the participant was able to continue with the study. A 21-day follow-up duration was selected to replicate the study period applied by Ryan and colleagues [20]. All data were recorded in a logbook by the researcher. No details of the fall or near-fall events were obtained. Participants were informed that they were able to contact the researcher either through text or telephone if needed when it is only safe to do so.
Statistical analysis for the pilot study
The feasibility outcomes were summarized descriptively and narratively. Descriptive statistics were used to summarize recruitment, retention, sample characteristics, incidence frequency of near-falls and falls and the types of balance recovery mechanisms used in near-falls.