Development of the Balance Recovery Falls-Efficacy Scale for the Community-dwelling Older Adults

NCT ID: NCT04087551

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-11
• Study Completion Date: 2020-09-15

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).

Conditions

Accidental Fall; Aging; Self Efficacy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Developing the list of items for BRFES

Two groups of six community-dwelling older adults will participate in a focus group session. Each focus group session will begin with a trained facilitator using a session guide welcoming the participants and introducing the participants in the group. The session will adopt a nominal group method which includes silent generation of ideas, sharing of an idea in a 'round robin' fashion, group discussion to clarify ideas and then completing the session with anonymous voting to include items into a list of items to be included in the Balance Recovery Falls-Efficacy Scale (BRFES).

Group Type: EXPERIMENTAL

Developing the list of items for BRFES

Intervention Type: OTHER

The finalized list of items will be discussed by two researchers who will combine similar items generated by the two focus groups to complete the Balance Recovery Falls-Efficacy Scale. The list of items has been developed by a group of community-dwelling older adults who had demonstrated an understanding of near-falls and will be able to articulate the use of balance recovery strategies used in near-fall experiences.

Interventions

Developing the list of items for BRFES

The finalized list of items will be discussed by two researchers who will combine similar items generated by the two focus groups to complete the Balance Recovery Falls-Efficacy Scale. The list of items has been developed by a group of community-dwelling older adults who had demonstrated an understanding of near-falls and will be able to articulate the use of balance recovery strategies used in near-fall experiences.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Singapore Institute of Technology

OTHER

Sponsor Role: collaborator

Queen Margaret University

OTHER

Sponsor Role: lead

Responsible Party

Shawn Leng-Hsien Soh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shawn Soh

Role: PRINCIPAL_INVESTIGATOR

Singapore Institute of Technology

Locations

Singapore Institute of Technology

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 33436025 (View on PubMed)

Other Identifiers

2019129

Identifier Type: OTHER

Identifier Source: secondary_id

REP 0197

Identifier Type: -

Identifier Source: org_study_id