Fall PreventionLIVE-LiFENCT03351413
Preventing Falls Among Older Fallers to Test the Effect of LIVE-LiFE, a Home-Based, Tailored Fall Prevention Program
A study testing LIVE-LiFE to Prevent Falls Among Older Fallers in people with Fall Prevention, run by Johns Hopkins University at 1 site in United States.
Trial summary
Purpose: To test the effect of LIVE-LiFE, a home-based, tailored fall prevention program for older adults with a high risk for falling. Study Type: Single-blind, two group randomized pilot trial. Randomization is 2:1 (27 intervention, 13 control). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention
- What is being tested?
- LIVE-LiFE to Prevent Falls Among Older Fallers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Aug 2019
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults ≥ 70 or older
- Self-report of 2 or more falls in the past 12 months OR 1 fall causing injury in the past 12 months
Who cannot join
- Moderate-severe memory problems
- No conversational English
- Not able to stand
- Resident in a nursing home or assisted living facility
- Hospitalized > 3 times in the last year
- Terminally ill (<1 year expected survival)
- Receiving active cancer treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SAFE-LiFE to Prevent Falls Among Older Fallers
Purpose: To test the effect of LIVE-LiFE, a home-based, tailored fall prevention program for older adults with a high risk for falling.
Study Type: Single-blind, two group randomized pilot trial. Randomization is 2:1 (27 intervention, 13 control). Participants have a chance of being in the LIVE-LiFE group or the control group.
Read more
Safe-LiFE Group: Individually tailored intervention at the participant's home spaced across 12 weeks including:
- Home safety assessment and risk reduction strategies; incorporating strength and balance training into daily habits vision screening and referral; and education about fear of falling and falls
- Home repairs, modifications, and low cost assistive devices to address unsafe home environments increasing fall risk
- Medication review and feedback concerning medications with increased fall risk
Control Group:
- An individualized fall risk assessment provided to participant and their primary care provider
Sample: 40 community-dwelling older adults in Baltimore City or County
- Conditions
- Fall Prevention
- Being tested
- LIVE-LiFE to Prevent Falls Among Older Fallers
- Keywords
- Fall Prevention, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIVE-LiFE to Prevent Falls Among Older FallersOther
Also called LIVE-LiFE
LIVE-LiFE Intervention: Individually tailored program at the participant's home spaced across 12 weeks including:
- Home safety assessment and risk reduction strategies; incorporating strength and balance training into daily habits vision screening and referral; and education about fear of falling and falls
- Home repairs, modifications, and low cost assistive devices to address unsafe home environments increasing fall risk
- Medication review and feedback concerning medications with increased fall risk
Measurement intervals: Baseline, 4 months, 8 months (with $25 gift card given at each visit for your time)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | LIVE-LiFE to Prevent Falls Among Older Fallers Intervention, which is an individually tailored program at the participant's home spaced across 12 weeks including:
* Home safety assessment and risk reduction strategies; incorporating strength and balance training into daily habits vision screening and referral; and education about fear of falling and falls
* Home repairs, modifications, and low cost assistive devices to address unsafe home environments increasing fall risk
* Medication review and feedback concerning medications with increased fall risk Receives: Other: LIVE-LiFE to Prevent Falls Among Older Fallers |
| Control | No intervention | - An individualized fall risk assessment provided to participant and their primary care provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Times Up and Go Test
A test used to assess the length of time it takes a person to get out of a chair, walk 10 feet, turn around and sit back down in the same chair.
Measured: Baseline to 16 weeks
Secondary outcomes (1)
Falls Self-Efficacy
The confidence a person has in their ability to walk without falling measured via a 10-item Likert -type 10-point scale with score ranges from 10-100, where 10 is low confidence and 100 is high confidence in their ability to perform various activities without falling.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Jul 2017
- Primary completion30 Apr 2019
- Study completion1 Aug 2019
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 Fall PreventionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, two group randomized pilot trial. Randomization is 2:1 (27 intervention, 13 control). Participants have a chance of being in the LIVE-LiFE group or the control group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Sarah L Szanton, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351413
- Sponsor's protocol ID
- IRB00141297
- Acronym
- LIVE-LiFE
- Status last verified
- Feb 2020
- First submitted
- 20 Nov 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Szanton SL, Clemson L, Liu M, Gitlin LN, Hladek MD, LaFave SE, Roth DL, Marx KA, Felix C, Okoye SM, Zhang X, Bautista S, Granbom M. Pilot Outcomes of a Multicomponent Fall Risk Program Integrated Into Daily Lives of Community-Dwelling Older Adults. J Appl Gerontol. 2021 Mar;40(3):320-327. doi: 10.1177/0733464820912664. Epub 2020 Mar 20.
PubMed 32193981Granbom M, Clemson L, Roberts L, Hladek MD, Okoye SM, Liu M, Felix C, Roth DL, Gitlin LN, Szanton S. Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program. Trials. 2019 Jan 3;20(1):2. doi: 10.1186/s13063-018-3114-5.
PubMed 30606239
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFE-LiFE to Prevent Falls Among Older Fallers
- ClinicalTrials.gov ID
- NCT03351413
- Acronym / sponsor ID
- LIVE-LiFE / IRB00141297
- Conditions
- Fall Prevention
- Keywords
- Fall Prevention, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 22 Nov 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.
Purpose: To test the effect of LIVE-LiFE, a home-based, tailored fall prevention program for older adults with a high risk for falling.
Study Type: Single-blind, two group randomized pilot trial. Randomization is 2:1 (27 intervention, 13 control). Participants have a chance of being in the LIVE-LiFE group or the control group.
Safe-LiFE Group: Individually tailored intervention at the participant's home spaced across 12 weeks including:
- Home safety assessment and risk reduction strategies; incorporating strength and balance training into daily habits vision screening and referral; and education about fear of falling and falls
- Home repairs, modifications, and low cost assistive devices to address unsafe home environments increasing fall risk
- Medication review and feedback concerning medications with increased fall risk
Control Group:
- An individualized fall risk assessment provided to participant and their primary care provider
Sample: 40 community-dwelling older adults in Baltimore City or County
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Single-blind, two group randomized pilot trial. Randomization is 2:1 (27 intervention, 13 control). Participants have a chance of being in the LIVE-LiFE group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: LIVE-LiFE to Prevent Falls Among Older FallersLIVE-LiFE to Prevent Falls Among Older Fallers Intervention, which is an individually tailored program at the participant's home spaced across 12 weeks including: * Home safety assessment and risk reduction strategies; incorporating strength and balance training into daily habits vision screening and referral; and education about fear of falling and falls * Home repairs, modifications, and low cost assistive devices to address unsafe home environments increasing fall risk * Medication review and feedback concerning medications with increased fall risk |
| Control | No intervention | –- An individualized fall risk assessment provided to participant and their primary care provider |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Adults ≥ 70 or older
- Self-report of 2 or more falls in the past 12 months OR 1 fall causing injury in the past 12 months
Key exclusion criteria (7 listed)
- Moderate-severe memory problems
- No conversational English
- Not able to stand
- Resident in a nursing home or assisted living facility
- Hospitalized > 3 times in the last year
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 |
|---|---|---|
| LIVE-LiFE to Prevent Falls Among Older FallersAlso: LIVE-LiFELIVE-LiFE Intervention: Individually tailored program at the participant's home spaced across 12 weeks including: * Home safety assessment and risk reduction strategies; incorporating strength and balance training into daily habits vision screening and referral; and education about fear of falling and falls * Home repairs, modifications, and low cost assistive devices to address unsafe home environments increasing fall risk * Medication review and feedback concerning medications with increased fall risk Measurement intervals: Baseline, 4 months, 8 months (with $25 gift card given at each visit for your time) | Other | Intervention |
Primary outcome
Times Up and Go Test
Time frame: Baseline to 16 weeks
A test used to assess the length of time it takes a person to get out of a chair, walk 10 feet, turn around and sit back down in the same chair.
1 secondary outcome
Falls Self-Efficacy
Time frame: Baseline to 16 weeks
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 11 Feb 2020.
- Derived from this study: PubMed 32193981Szanton SL, Clemson L, Liu M, Gitlin LN, Hladek MD, LaFave SE, Roth DL, Marx KA, Felix C, Okoye SM, Zhang X, Bautista S, Granbom M. Pilot Outcomes of a Multicomponent Fall Risk Program Integrated Into Daily Lives of Community-Dwelling Older Adults. J Appl Gerontol. 2021 Mar;40(3):320-327. doi: 10.1177/0733464820912664. Epub 2020 Mar 20.
- Derived from this study: PubMed 30606239Granbom M, Clemson L, Roberts L, Hladek MD, Okoye SM, Liu M, Felix C, Roth DL, Gitlin LN, Szanton S. Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program. Trials. 2019 Jan 3;20(1):2. doi: 10.1186/s13063-018-3114-5.
- 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.
Sarah L Szanton, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIVE-LiFE to Prevent Falls Among Older Fallers in people with Fall Prevention, run by Johns Hopkins University at 1 site in United States.
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 2 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 11 Feb 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 United States. 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?
Times Up and Go Test (time frame: Baseline to 16 weeks). 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 NCT03351413, 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 11 Feb 2020.