Falls RiskNCT05198193
Evaluation and Development of Falls Prevention and Management in the Community for Older Adults
A study testing No Message Given, Positive Message Given - Older Adults and Negative Message Given - Older Adults in people with Falls Risk and Falls Prevention, run by National University of Singapore at 1 site in Singapore.
Trial summary
This study investigates how differently-framed messages can affect people's attitude towards falls risk and prevention in older adults. This study considers the potentiality of adult children acting as change agents in influencing parents in falls prevention. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls Risk, Falls Prevention
- What is being tested?
- No Message Given, Positive Message Given - Older Adults and Negative Message Given - Older Adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Dec 2021to 30 Sep 2022
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singaporean or Permanent Residents (PRs)
- Read/speak English, Mandarin, or Malay
- Either age 60 years old and above, walk independently with or without assistive devices, have no self-reported/detected dementia or cognitive impairments or age between 30 and 59 years old and have either one of the parents age 60 years old and above who walk independently with or without assistive devices
Who cannot join
- Not Singaporean or PRs
- Do not read/speak English, Chinese, and Malay
- Age 29 years old and below
- Cannot walk independently with and without assistive devices
- Have self-reported/detected dementia or cognitive impairments
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University of Singapore
Singapore
Su-Chin Hsu, +6566011672, schsu@nus.edu.sg
About this study
Official title: Evaluation and Development of Falls Prevention and Management in the Community of Central and North of Singapore for Older Adults
This study investigates how differently-framed messages can affect people's attitude towards falls risk and prevention in older adults. This study considers the potentiality of adult children acting as change agents in influencing parents in falls prevention.
Read the detailed description
A randomized controlled trial (RCT) will be conducted to test the effectiveness of two messaging types (positively vs negatively framed) via two target audiences (older vs younger adults).
The RCT evaluates the effectiveness of the differently-framed messages delivered to older and younger adults in affecting people's attitude toward falls risk and motivating them to learn about preventing falls. Also, the potential of adult children acting as change agents to positively influence parents in preventing falls is explored.
Older and younger adults who are eligible to participate in this study are randomly given one message. For older adults, the objective is to study which message is more effective in affecting their attitude towards falls risk and motivating them to learn about preventing falls. For younger adults, the aim is to understand which message is more effective in motivating them to learn about preventing falls for their parents.
Hypotheses:
H1: The negatively framed message is more effective than the positively framed counterpart in motivating older adults to find out about preventing falls. However, this effect decreases as the socioeconomic status decreases.
H2: The negatively framed message is more effective than the positively framed counterpart in motivating younger adults to find out about preventing falls.
- Conditions
- Falls Risk, Falls Prevention
- Being tested
- No Message Given, Positive Message Given - Older Adults, Negative Message Given - Older Adults, Positive Message Given - Younger Adults, Negative Message Given - Younger Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Message GivenBehavioural
Participants in this arm are not given any intervention.
Positive Message Given - Older AdultsBehavioural
Participants in this arm are given a positively framed message from an older adult's point of view.
Negative Message Given - Older AdultsBehavioural
Participants in this arm are given a negatively framed message from an older adult's point of view.
Positive Message Given - Younger AdultsBehavioural
Participants in this arm are given a positively framed message from an adult child's point of view.
Negative Message Given - Younger AdultsBehavioural
Participants in this arm are given a negatively framed message from an adult child's point of view.
| Study group | Role | What they receive |
|---|---|---|
| Control - Older Adults | Experimental | Participants age 60 years old or above. Receives: Behavioral: No Message Given |
| Positive - Older Adults | Experimental | Participants age 60 years old or above. Receives: Behavioral: Positive Message Given - Older Adults |
| Negative - Older Adults | Experimental | Participants age 60 years old or above. Receives: Behavioral: Negative Message Given - Older Adults |
| Control - Younger Adults | Experimental | Participants age between 30 and 59 years old. Receives: Behavioral: No Message Given |
| Positive - Younger Adults | Experimental | Participants age between 30 and 59 years old. Receives: Behavioral: Positive Message Given - Younger Adults |
| Negative - Younger Adults | Experimental | Participants age between 30 and 59 years old. Receives: Behavioral: Negative Message Given - Younger Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
How much does the participant want to find out about preventing falls for himself/herself or his/her father/mother?
This is a scale variable ranging from 1 to 9, which is "1" if not at all and "9" if a lot
Measured: After being given a message during the survey, an average of 2 minutes
Secondary outcomes (3)
Whether the participant or the participant's father/mother has fallen in the past 12 months
This is a categorical variable, which is "Yes" if the participant or the participant's father/mother has fallen in the past 12 months, "No" if not, and "Do not know" if the participant does not know whether his/her father/mother has fallen in the past 12 months
Measured: After being given a message during the survey, an average of 2 minutes
Whether the participant or the participant's father/mother is concerned about falling
This is a categorical variable, which is "Very concerned" if the participant or the participant's father/mother is very concerned about falling, "Slightly concerned" if s/he is slightly concerned about falling, "Not concerned" if s/he is not concerned about falling, and "Do not know" if the participant does not know whether his/her father/mother is concerned about falling
Measured: After being given a message during the survey, an average of 2 minutes
Whether the participant or the participant's father/mother feels like s/he is going to fall when standing or walking
This is a categorical variable, which is "Always" if the participant or the participant's father/mother always feels like s/he is going to fall when standing or walking, "Sometimes" if s/he sometimes feels like s/he is going to fall when standing or walking, "Never" if s/he never feels like s/he is going to fall when standing or walking, and "Do not know" if the participant does not know whether his/her father/mother feels like s/he is going to fall when standing or walking
Measured: After being given a message during the survey, an average of 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start10 Dec 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Falls RiskStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noah Lim, National University of Singapore
- Investigators
- Noah Lim, PhD, Study director, The Global Asia Institute, The National University of SingaporeTuo-Yu Chen, PhD, Principal investigator, Master Program in Global Health and Development, Taipei Medical UniversitySu-Chin Hsu, PhD, Principal investigator, The Global Asia Institute, The National University of SingaporeLianjun Li, PhD, Principal investigator, The Global Asia Institute, The National University of SingaporeCatherine Yeung, PhD, Principal investigator, Department of Marketing, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198193
- Sponsor's protocol ID
- NUS-IRB-2020-024
- Status last verified
- Apr 2022
- First submitted
- 7 Dec 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dickinson A, Machen I, Horton K, Jain D, Maddex T, Cove J. Fall prevention in the community: what older people say they need. Br J Community Nurs. 2011 Apr;16(4):174-80. doi: 10.12968/bjcn.2011.16.4.174.
PubMed 21471918Liu X, Shuster MM, Mikels JA, Stine-Morrow EAL. Doing What Makes You Happy: Health Message Framing for Younger and Older Adults. Exp Aging Res. 2019 Jul-Sep;45(4):293-305. doi: 10.1080/0361073X.2019.1627491. Epub 2019 Jun 12.
PubMed 31188722
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Development of Falls Prevention and Management in the Community of Central and North of Singapore for Older Adults
- ClinicalTrials.gov ID
- NCT05198193
- Acronym / sponsor ID
- NUS-IRB-2020-024
- Conditions
- Falls Risk, Falls Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 20 Jan 2022 (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.
This study investigates how differently-framed messages can affect people's attitude towards falls risk and prevention in older adults. This study considers the potentiality of adult children acting as change agents in influencing parents in falls prevention.
Detailed description
A randomized controlled trial (RCT) will be conducted to test the effectiveness of two messaging types (positively vs negatively framed) via two target audiences (older vs younger adults).
The RCT evaluates the effectiveness of the differently-framed messages delivered to older and younger adults in affecting people's attitude toward falls risk and motivating them to learn about preventing falls. Also, the potential of adult children acting as change agents to positively influence parents in preventing falls is explored.
Older and younger adults who are eligible to participate in this study are randomly given one message. For older adults, the objective is to study which message is more effective in affecting their attitude towards falls risk and motivating them to learn about preventing falls. For younger adults, the aim is to understand which message is more effective in motivating them to learn about preventing falls for their parents.
Hypotheses:
H1: The negatively framed message is more effective than the positively framed counterpart in motivating older adults to find out about preventing falls. However, this effect decreases as the socioeconomic status decreases.
H2: The negatively framed message is more effective than the positively framed counterpart in motivating younger adults to find out about preventing falls.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control - Older Adults | Experimental | Behavioral: No Message GivenParticipants age 60 years old or above. |
| Positive - Older Adults | Experimental | Behavioral: Positive Message Given - Older AdultsParticipants age 60 years old or above. |
| Negative - Older Adults | Experimental | Behavioral: Negative Message Given - Older AdultsParticipants age 60 years old or above. |
| Control - Younger Adults | Experimental | Behavioral: No Message GivenParticipants age between 30 and 59 years old. |
| Positive - Younger Adults | Experimental | Behavioral: Positive Message Given - Younger AdultsParticipants age between 30 and 59 years old. |
| Negative - Younger Adults | Experimental | Behavioral: Negative Message Given - Younger AdultsParticipants age between 30 and 59 years old. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Singaporean or Permanent Residents (PRs)
- Read/speak English, Mandarin, or Malay
- Either age 60 years old and above, walk independently with or without assistive devices, have no self-reported/detected dementia or cognitive impairments or age between 30 and 59 years old and have either one of the parents age 60 years old and above who walk independently with or without assistive devices
Key exclusion criteria (5 listed)
- Not Singaporean or PRs
- Do not read/speak English, Chinese, and Malay
- Age 29 years old and below
- Cannot walk independently with and without assistive devices
- Have self-reported/detected dementia or cognitive impairments
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 |
|---|---|---|
| No Message GivenParticipants in this arm are not given any intervention. | Behavioural | Control - Older Adults, Control - Younger Adults |
| Positive Message Given - Older AdultsParticipants in this arm are given a positively framed message from an older adult's point of view. | Behavioural | Positive - Older Adults |
| Negative Message Given - Older AdultsParticipants in this arm are given a negatively framed message from an older adult's point of view. | Behavioural | Negative - Older Adults |
| Positive Message Given - Younger AdultsParticipants in this arm are given a positively framed message from an adult child's point of view. | Behavioural | Positive - Younger Adults |
| Negative Message Given - Younger AdultsParticipants in this arm are given a negatively framed message from an adult child's point of view. | Behavioural | Negative - Younger Adults |
Primary outcome
How much does the participant want to find out about preventing falls for himself/herself or his/her father/mother?
Time frame: After being given a message during the survey, an average of 2 minutes
This is a scale variable ranging from 1 to 9, which is "1" if not at all and "9" if a lot
3 secondary outcomes
Whether the participant or the participant's father/mother has fallen in the past 12 months
Time frame: After being given a message during the survey, an average of 2 minutes
Whether the participant or the participant's father/mother is concerned about falling
Time frame: After being given a message during the survey, an average of 2 minutes
Whether the participant or the participant's father/mother feels like s/he is going to fall when standing or walking
Time frame: After being given a message during the survey, an average of 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Background: PubMed 21471918Dickinson A, Machen I, Horton K, Jain D, Maddex T, Cove J. Fall prevention in the community: what older people say they need. Br J Community Nurs. 2011 Apr;16(4):174-80. doi: 10.12968/bjcn.2011.16.4.174.
- Background: PubMed 31188722Liu X, Shuster MM, Mikels JA, Stine-Morrow EAL. Doing What Makes You Happy: Health Message Framing for Younger and Older Adults. Exp Aging Res. 2019 Jul-Sep;45(4):293-305. doi: 10.1080/0361073X.2019.1627491. Epub 2019 Jun 12.
- Individual participant dataSharing planned: No
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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.
Noah Lim, PhD study director
The Global Asia Institute, The National University of Singapore
Tuo-Yu Chen, PhD principal investigator
Master Program in Global Health and Development, Taipei Medical University
Su-Chin Hsu, PhD principal investigator
The Global Asia Institute, The National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Message Given, Positive Message Given - Older Adults and Negative Message Given - Older Adults in people with Falls Risk and Falls Prevention, run by National University of Singapore 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su-Chin Hsu, PhD (+6566011672, schsu@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How much does the participant want to find out about preventing falls for himself/herself or his/her father/mother? (time frame: After being given a message during the survey, an average of 2 minutes). 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 NCT05198193, which also lists 2 linked publications.
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 14 Apr 2022.