Age ProblemNCT03154788
Falls Risk Awareness Video Study
An observational study of Age Problem, run by Curtin University at 1 site in Australia.
Trial summary
The primary aim of this study is to develop and evaluate three short corporate falls risk awareness videos of approximately 1-2 minutes (each) by using the feedback from community-dwelling people aged 50 years and above. The three videos aim to make a broad audience aware of the risk of falling as one gets older. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Problem
- How many people
- 92 participants
- Where
- 1 siteAustralia
- Study dates
- 15 May 2017to 12 Oct 2017
- Phase
- Observational
- 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 50 years and older
- All sexes
- Adult, Older adult
Study population: Community-dwelling older people.
Who may be able to join
- Aged 50 years and older living in the (Greater) Perth region, Western Australia.
- Living independently (this can include living with others, receiving assistance for daily tasks, or living in a retirement village).
- Sufficiently mobile to attend a community focus group or World Cafe Forum (i.e. be able to leave their home with or without assistance).
- Sufficient English language skills (self-assessed) to be able to successfully join in the focus group and World Cafe forum discussion(s).
- Able to provide written informed consent.
Who cannot join
- Living in a nursing home.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Evaluating a Series of Falls Risk Awareness Corporate Videos Which Target Community-dwelling Older People: a Sequential Mixed-method Study.
The primary aim of this study is to develop and evaluate three short corporate falls risk awareness videos of approximately 1-2 minutes (each) by using the feedback from community-dwelling people aged 50 years and above. The three videos aim to make a broad audience aware of the risk of falling as one gets older.
Read the detailed description
Every year one in three people aged 60 years and above fall over. More than 96.000 Australians are admitted to hospital each year due to a fall and this number is rising by 2% each year. People who have had a fall account for almost 40% of all hospitalised injury cases, with almost half of those falls resulting in injuries such as broken hips, neck- and head injuries. In 2015 almost 2300 Australians died as a direct result of a fall, a number which is more than three times higher than the number of people who die in car accidents.
Given the high risk of experiencing (an) (injurious) fall(s), various campaigns have been conducted with the aim of making older people aware that it is important to prevent falls. Also, numerous resources (websites, leaflets) are available to the general public that inform them of the several activities they can undertake to reduce their risk of falls. However, these campaigns and available resources do not seem to be compelling enough. Research has shown that people over the age of 60 still tend to underestimate their own risk of a fall, and have low levels of knowledge about how to prevent falls. Also, many older people report that they are not motivated to take action to reduce their risk of falls even thought they think that falls prevention would be useful for other older people. In particular older people state that they seek out information only after they fall and not before. It would be beneficial if the broad population and people over the age of 60 in particular, were more aware about falls and more motivated to take action(s) to reduce their risk of falling. Therefore the investigators aim to develop three short falls risk awareness videos that are appealing to people of all age groups and especially people aged 60 years and above.
Based on research findings by the investigators, to date three prototype versions of short falls risk awareness videos have been developed. During this research project these videos will be evaluated and then amended and developed further according to the feedback given by the participants. The feedback from participants will be sought in two phases.
Phase 1 In the first phase 50 community-dwelling older people over the age of 50 will be invited to share their thoughts and opinions about the prototype versions of the three falls risk awareness videos. For the participants in this phase of the study it will involve attending a focus group meeting of about 1½ hour in total together with 8-10 other participants. During this focus group meeting (but prior to the actual discussion about the videos) the researchers will also ask the participants to help test a questionnaire which is developed specifically for the purpose of this study. Participants will be asked to fill in the questionnaire twice (with a 20 minute rest in between). Questions pertain to the participants' knowledge of falls and their capabilities and motivation towards undertaking fall prevention activities. The researchers plan to use this questionnaire in the second phase of the project. It this phase it is solely used to measure the time taken to complete the questionnaire and to establish its reliability (and not to actually measure the outcomes at this point). Then the prototype videos will be shown twice, followed by a discussion group of around 45-50 minutes in which several questions will be asked about the content and the appeal of the three videos. Subsequent to the focus groups, the participants' feedback on the prototype videos will be evaluated and used to amend/develop the videos further.
Phase 2 During the second phase of this research study the amended videos will be screened to a larger audience of about 100 community-dwelling people aged 50 years and above during a World Café forum. This is a research design that specifically aims to gain consumers opinions about topics of interest. The aim of this forum is to seek these people's feedback on the three videos. In addition, the researchers will evaluate if having watched these three videos has changed the forum attendees' knowledge, intentions and some basic beliefs towards falls and engaging in falls prevention activities. This will be measured using the questionnaire that was pretested for reliability in the first phase of the study. The participants' feedback about the videos will be evaluated and used to develop the final versions of the videos. These final videos will be used in a future research study, most likely by being placed online and evaluated using the questionnaire previously developed.
- Conditions
- Age Problem
- Keywords
- Falls prevention, Community-Based Participatory Research
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactions to prototype versions of the three short corporate falls risk awareness videos.
Qualitative data collected during focus groups (phase 1)
Measured: 6 months.
Reactions to prototype versions of the three short corporate falls risk awareness videos.
Qualitative data collected during a World Cafe Forum (phase 2)
Measured: 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start15 May 2017
- Primary completion12 Oct 2017
- Study completion12 Oct 2017
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 Age ProblemStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lex de Jong, Curtin University
- Investigators
- Lex de Jong, PhD, Principal investigator, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154788
- Sponsor's protocol ID
- HRE2017-0038
- Status last verified
- Nov 2017
- First submitted
- 11 May 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Jong LD, Francis-Coad J, Wortham C, Haines TP, Skelton DA, Weselman T, Hill AM. Evaluating audio-visual falls prevention messages with community-dwelling older people using a World Cafe forum approach. BMC Geriatr. 2019 Dec 9;19(1):345. doi: 10.1186/s12877-019-1344-3.
PubMed 31818252
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating a Series of Falls Risk Awareness Corporate Videos Which Target Community-dwelling Older People: a Sequential Mixed-method Study.
- ClinicalTrials.gov ID
- NCT03154788
- Acronym / sponsor ID
- HRE2017-0038
- Conditions
- Age Problem
- Keywords
- Falls prevention, Community-Based Participatory Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 16 May 2017 (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 primary aim of this study is to develop and evaluate three short corporate falls risk awareness videos of approximately 1-2 minutes (each) by using the feedback from community-dwelling people aged 50 years and above. The three videos aim to make a broad audience aware of the risk of falling as one gets older.
Detailed description
Every year one in three people aged 60 years and above fall over. More than 96.000 Australians are admitted to hospital each year due to a fall and this number is rising by 2% each year. People who have had a fall account for almost 40% of all hospitalised injury cases, with almost half of those falls resulting in injuries such as broken hips, neck- and head injuries. In 2015 almost 2300 Australians died as a direct result of a fall, a number which is more than three times higher than the number of people who die in car accidents.
Given the high risk of experiencing (an) (injurious) fall(s), various campaigns have been conducted with the aim of making older people aware that it is important to prevent falls. Also, numerous resources (websites, leaflets) are available to the general public that inform them of the several activities they can undertake to reduce their risk of falls. However, these campaigns and available resources do not seem to be compelling enough. Research has shown that people over the age of 60 still tend to underestimate their own risk of a fall, and have low levels of knowledge about how to prevent falls. Also, many older people report that they are not motivated to take action to reduce their risk of falls even thought they think that falls prevention would be useful for other older people. In particular older people state that they seek out information only after they fall and not before. It would be beneficial if the broad population and people over the age of 60 in particular, were more aware about falls and more motivated to take action(s) to reduce their risk of falling. Therefore the investigators aim to develop three short falls risk awareness videos that are appealing to people of all age groups and especially people aged 60 years and above.
Based on research findings by the investigators, to date three prototype versions of short falls risk awareness videos have been developed. During this research project these videos will be evaluated and then amended and developed further according to the feedback given by the participants. The feedback from participants will be sought in two phases.
Phase 1 In the first phase 50 community-dwelling older people over the age of 50 will be invited to share their thoughts and opinions about the prototype versions of the three falls risk awareness videos. For the participants in this phase of the study it will involve attending a focus group meeting of about 1½ hour in total together with 8-10 other participants. During this focus group meeting (but prior to the actual discussion about the videos) the researchers will also ask the participants to help test a questionnaire which is developed specifically for the purpose of this study. Participants will be asked to fill in the questionnaire twice (with a 20 minute rest in between). Questions pertain to the participants' knowledge of falls and their capabilities and motivation towards undertaking fall prevention activities. The researchers plan to use this questionnaire in the second phase of the project. It this phase it is solely used to measure the time taken to complete the questionnaire and to establish its reliability (and not to actually measure the outcomes at this point). Then the prototype videos will be shown twice, followed by a discussion group of around 45-50 minutes in which several questions will be asked about the content and the appeal of the three videos. Subsequent to the focus groups, the participants' feedback on the prototype videos will be evaluated and used to amend/develop the videos further.
Phase 2 During the second phase of this research study the amended videos will be screened to a larger audience of about 100 community-dwelling people aged 50 years and above during a World Café forum. This is a research design that specifically aims to gain consumers opinions about topics of interest. The aim of this forum is to seek these people's feedback on the three videos. In addition, the researchers will evaluate if having watched these three videos has changed the forum attendees' knowledge, intentions and some basic beliefs towards falls and engaging in falls prevention activities. This will be measured using the questionnaire that was pretested for reliability in the first phase of the study. The participants' feedback about the videos will be evaluated and used to develop the final versions of the videos. These final videos will be used in a future research study, most likely by being placed online and evaluated using the questionnaire previously developed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling older people.
Key inclusion criteria (5 listed)
- Aged 50 years and older living in the (Greater) Perth region, Western Australia.
- Living independently (this can include living with others, receiving assistance for daily tasks, or living in a retirement village).
- Sufficiently mobile to attend a community focus group or World Cafe Forum (i.e. be able to leave their home with or without assistance).
- Sufficient English language skills (self-assessed) to be able to successfully join in the focus group and World Cafe forum discussion(s).
- Able to provide written informed consent.
Key exclusion criteria (1 listed)
- Living in a nursing home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reactions to prototype versions of the three short corporate falls risk awareness videos.
Time frame: 6 months.
Qualitative data collected during focus groups (phase 1)
Reactions to prototype versions of the three short corporate falls risk awareness videos.
Time frame: 18 months.
Qualitative data collected during a World Cafe Forum (phase 2)
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 21 Nov 2017.
- Derived from this study: PubMed 31818252de Jong LD, Francis-Coad J, Wortham C, Haines TP, Skelton DA, Weselman T, Hill AM. Evaluating audio-visual falls prevention messages with community-dwelling older people using a World Cafe forum approach. BMC Geriatr. 2019 Dec 9;19(1):345. doi: 10.1186/s12877-019-1344-3.
- Individual participant dataSharing planned: Undecided
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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.
Lex de Jong, PhD principal investigator
Curtin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Problem, run by Curtin University at 1 site in Australia.
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 5 inclusion and 1 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 21 Nov 2017. 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 Australia. 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?
Reactions to prototype versions of the three short corporate falls risk awareness videos. (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 NCT03154788, 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 21 Nov 2017.