Accidental FallNCT04087551
Development of the Balance Recovery Falls-Efficacy Scale for the Community-dwelling Older Adults
A study testing Developing the list of items for BRFES in people with Accidental Fall and Aging, run by Queen Margaret University at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall, Aging, Self Efficacy
- What is being tested?
- Developing the list of items for BRFES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Sep 2019to 15 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Near-falls and the Development of the Balance Recovery Falls-efficacy Scale (BRFES) for the Community-dwelling Older Adults.
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.
Read the 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
- Being tested
- Developing the list of items for BRFES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developing the list of items for BRFESOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Developing the list of items for BRFES | Experimental | 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). Receives: Other: Developing the list of items for BRFES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of near-falls
To determine the incidence of near-falls
Measured: 6 months
Development of the Balance Recovery Falls-Efficacy Scale (BRFES)
To develop and validate the Balance Recovery Falls-Efficacy Scale (BRFES).
The construct measured is the confidence in one's ability to execute balance recovery manoeuvres in common, everyday functional activities to prevent a fall. The scale response option ranged from 1 to 10 with a higher score reflecting higher confidence. The scale would have 16 items indicating a total score range of 16 to 160. A higher total score value represent a better outcome.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start11 Sep 2019
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Institute of Technology
- Responsible party
- Principal investigator, Shawn Leng-Hsien Soh, Queen Margaret University
- Investigators
- Shawn Soh, Principal investigator, Singapore Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087551
- Sponsor's protocol ID
- REP 0197
- Other IDs
- 2019129
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33436025
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Near-falls and the Development of the Balance Recovery Falls-efficacy Scale (BRFES) for the Community-dwelling Older Adults.
- ClinicalTrials.gov ID
- NCT04087551
- Acronym / sponsor ID
- REP 0197
- Conditions
- Accidental Fall, Aging, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- Singapore Institute of Technology
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Developing the list of items for BRFES | Experimental | Other: Developing the list of items for BRFESTwo 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Developing the list of items for BRFESThe 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. | Other | Developing the list of items for BRFES |
Primary outcome
Incidence of near-falls
Time frame: 6 months
To determine the incidence of near-falls
Development of the Balance Recovery Falls-Efficacy Scale (BRFES)
Time frame: 9 months
To develop and validate the Balance Recovery Falls-Efficacy Scale (BRFES). The construct measured is the confidence in one's ability to execute balance recovery manoeuvres in common, everyday functional activities to prevent a fall. The scale response option ranged from 1 to 10 with a higher score reflecting higher confidence. The scale would have 16 items indicating a total score range of 16 to 160. A higher total score value represent a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 33436025Soh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn Soh principal investigator
Singapore Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Developing the list of items for BRFES in people with Accidental Fall and Aging, run by Queen Margaret University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of near-falls (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04087551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.