Clinical trial NCT04087551: Development of the Balance Recovery Falls-Efficacy Scale for the Community-dwelling Older Adults
Official title: Incidence of Near-falls and the Development of the Balance Recovery Falls-efficacy Scale (BRFES) for the Community-dwelling Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Fall
Aging
Self Efficacy
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: Singapore Institute of Technology
First posted: 2019-09-12
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1 Participants will be requested to report the incidence of no fall, near-fall or a fall daily over the next 21-day period. There will be 3 options given to the participants: (1) a daily telephone call at a prearranged timing or (2) a daily text message given at a prearranged timing or both. A study administrator will contact the participant daily using the preferred mode of reporting. All information will be recorded in a logbook.

Phase 2 The development of the Balance Recovery Falls-Efficacy scale will be guided using the COSMIN methodology. This development is based on inputs from the community-dwelling older adults to ensure relevance, comprehensiveness and comprehensibility. The scale would then be validated with a group of healthcare professionals and another new group of community-dwelling older adults using the Delphi method.
Primary purpose: OTHER

Brief summary: The first phase of the study aims to study the incidence of near-falls. The second phase will be to develop a scale which operationalize balance recovery confidence in the older adults. This study will determine the incidence of near-falls in a sample of community-dwelling older adults and will develop the Balance Recovery Falls-Efficacy scale (BRFES) for the community-dwelling older adults using the COSMIN method. This scale will be used to measure the confidence level of the community-dwelling older adults in their ability to execute balance recovery maneuvers in common, everyday functional activities to prevent a fall.

Detailed description: This study will progress through two phases

The first phase will recruit 30 older adults from ages of 65 and older living in the community. A study administrator will contact the participants daily over a 21-day period to obtain frequency and type of event experienced e.g. no fall, fall, near fall (hand), near-fall (leg) or near-fall (other). No other details of the event will be ascertained because this preliminary study will be to determine the incidence of near-falls in a sample of community-dwelling seniors.

The second phase will be to develop a scale which operationalize balance recovery confidence in community-dwelling older adults. In the first stage of the study, twelve older adults will be recruited to develop a comprehensive list of relevant items for the scale. Purposive sampling will be used to invite participants from the earlier study. This approach will ensure sample representativeness of the population and to include participants who have had demonstrated an understanding of near-falls and balance recovery maneuvres in the previous study to develop the scale. An exhaustive list of scale items will be generated from two focus group formed by six participants using a nominal group technique. This consensus-based technique ensures that all items in the scale are relevant and comprehensible to the community-dwelling older adults to discriminate the confidence level in one's ability to perform balance recovery maneuvres. The scale will then be sent to a panel of 50 experts including healthcare professionals as well as a new group of community-dwelling older adults to determine the appropriateness of items ensuring that the scale is relevant, comprehensive and comprehensible. Delphi technique will be adopted as the method to obtain a consensus among experts to finalize the Balance Recovery Falls-Efficacy Scale (BRFES).

Eligibility criteria: Inclusion Criteria:

* 65-year-old and above
* Ability to read, write and communicate in English
* History of at least one near-fall or one fall within the last 12 months
* Living independently in the community with or without the use of a walking aid
* Not having any cognitive dysfunction by achieving a score of 7 or less in the 6-item cognitive impairment test (6CIT)
* Able to walk 6 meters within 12 seconds by performing the Timed Up and Go (TUG) test
* Able to catch a 30cm ruler by each hands using the ruler drop test

Exclusion Criteria:

* Requiring any physical assistance from another person to walk within home
* Known active malignant conditions
* 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 3 months
* Pulmonary conditions e.g. serious chronic obstructive pulmonary disease or oxygen dependence
* 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 6 months
* Neurological conditions such as Parkinson's Disease, sequelae of stroke, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS) or severe Dementia or epilepsy
* Legal blindness, severe visual impairment, severe hearing impairment or legal deafness

Primary outcomes:
measure: Incidence of near-falls
timeFrame: 6 months
measure: Development of the Balance Recovery Falls-Efficacy Scale (BRFES)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Institute of Technology
Study officials:
affiliation: Singapore Institute of Technology
name: Shawn Soh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soh SL, Tan CW, Lane J, Yeh TT, Soon B. Near-falls in Singapore community-dwelling older adults: a feasibility study. Pilot Feasibility Stud. 2021 Jan 12;7(1):25. doi: 10.1186/s40814-020-00748-1.