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Falls Related Risk Factors in the ElderlyNCT03935867

New York University Falls Prevention Program

A study testing C-PROFET in people with Falls Related Risk Factors in the Elderly, run by New York University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Limited health services research and evidence-based programming has been focused on elderly fall prevention, despite high fall-related morbidity and mortality. Among NY's elderly population, falls account for nearly half of all older adults' injury-related deaths and are the 4th leading cause of hospitalizations. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
C-PROFET
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
29 Jul 2016to 31 Jul 2024
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
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Is 65 years of age or older
  • Lives in the New York metropolitan area
  • Lives in a private residence or assisted living apartment
  • Understands English
  • Has one or more fall risk factors
  • Has not had a prior fall-related injury requiring emergency care
  • Is cognitively competent and has the capacity to give consent

Who cannot join

  • Has had a prior fall related injury requiring emergency care
  • Will be unavailable for a home visit within the next 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York University College of Dentistry

    New York, New York, 10010

Other trials in United States

About this study

Official title: New York University (NYU) Falls Prevention Program

Limited health services research and evidence-based programming has been focused on elderly fall prevention, despite high fall-related morbidity and mortality. Among NY's elderly population, falls account for nearly half of all older adults' injury-related deaths and are the 4th leading cause of hospitalizations. As fall risk increases with age, the magnitude of this health issue will continue to increase. Scientific evidence shows that prevention efforts significantly reduce the frequency and severity of falls. Research also suggests that multi-component intervention programs, such as Prevention Of Falls in the Elderly Trial, "PROFET", are successful because benefits are derived from small improvements across several risk categories.

The investigators propose expanding the reach of fall prevention efforts to at-risk and underserved populations of community-dwelling, older adults by delivering a home-based program -- "C-PROFET", an adaptation of Prevention Of Falls in the Elderly Trial (PROFET), an evidence-based, multi-factorial, fall prevention program. Investigators will test two hypotheses: (1) Oral health care programs and services can be a portal for identifying underserved community dwelling elders at risk for falls who can benefit from a fall prevention program; and (2) Provision of fall prevention efforts to an at-risk clinical population before these patients experience a serious fall-related injury will reduce fall-risk, and potentially decrease fall-related morbidity, mortality, and healthcare costs.

This initiative is to lay the necessary groundwork for larger implementation efforts that will advance efforts to reduce fall risk in vulnerable, community-dwelling older adults. The investigators propose to deliver "C-PROFET" to vulnerable, older adults identified through dental clinics and community oral health outreach services. The overall objectives are to improve patient-centered health outcomes, demonstrate feasibility of a multicomponent intervention to reduce/prevent fall-related morbidity and mortality in an at-risk, community-dwelling, clinical population, and disseminate this falls prevention program to community partner organizations to broadly translate these findings into clinical practice.

Read the detailed description

Implementing innovative, cost-effective community-based delivery modalities that reliably and effectively deliver evidence-based, culturally-sensitive programs, proven to prevent injury, preserve function, improve quality of life, and reduce morbidity and mortality among an older and more diverse population, will significantly impact health costs and help address the anticipated surge in demand for health services and long-term care. Such efforts need to appeal to diverse populations and have outcomes achievable with a community delivery.

This application is proposing to expand the reach of an evidence-based program, "PROFET", developed for older adults who experienced a fall-related injury, to an at risk community-dwelling population who have not sustained a fall-related injury requiring medical intervention. The investigators hypothesize that oral health care programs and services can be a portal for identifying underserved community dwelling elders at risk for falls who can benefit from a fall prevention program. As more adults see their dentist than visit a physician in a given year, dental clinics, a safety net site for the delivery of oral health care to the elderly, are ideally situated to take an active role in injury prevention efforts. Dental clinics attached to community health centers and academic institutions have established linkages and referral patterns across systems of care and disciplines that can facilitate delivery of preventive services prior to an injury-sustaining event, delaying or preventing unintentional injuries. To date, fall prevention efforts have predominately targeted those who have already experienced an injury-sustaining fall. All older adults may profit from fall prevention interventions (regardless of whether they have experienced a fall-related serious injury). Expanding delivery to reach an at-risk population living in the community, will enable earlier intervention efforts to prevent/reduce falls, serious injury and hospital stays including a first serious fall which in and of itself increases risk for subsequent serious falls.

The aims of this initiative are to: (1) adapt and deliver "C-PROFET", an evidence-based, multifactor fall prevention program, to at-risk, community-dwelling older (65+), multi-ethnic, economically constrained, community residents (n=30) identified in non-traditional community settings (general dental clinic and community dental outreach program delivering oral health care to the elderly in community-based facilities, including senior centers); and (2) to assess the reach, uptake, feasibility and acceptability of the program. NYU College of Dentistry (NYUCD) dental clinic is a low cost community clinic providing quality dental care to the uninsured and those living on a restricted income. The clinic maintains over 300,000 patient visits annually and 17% of the patient population are 65 and older. Examination of the utility of the dental clinic and dental outreach program as a portal for fall prevention programs will be guided by the "RE-AIM" framework which consists of five core elements: (1) Reach ("How do investigators reach the targeted population?"); (2) Effectiveness ("How do investigators know the program is effective?); (3) Adoption ("How effective is this program in different settings?"); (4) Implementation ("How do investigators ensure that the program is delivered consistently?"); (5) Maintenance ("How do investigators incorporate the program so that it is delivered over the long term?").

Being tested
C-PROFET

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • C-PROFETBehavioural

    An expansion of the evidence-based, multi-factorial, fall prevention program PROFET (Prevention Of Falls in the Elderly Trial), developed for older adults who experienced a fall-related injury, to an at risk community-dwelling population who have not sustained a fall-related injury requiring medical intervention.

Study groups in NCT03935867
Study groupRoleWhat they receive
C-PROFET groupExperimentalCommunity-dwelling, older adults participating in a home-based program -- C-PROFET, our adaptation of Prevention Of Falls in the Elderly Trial (PROFET).
Receives: Behavioral: C-PROFET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A change in environmental falls-related risk factors in the home

    A Home Hazards and Safety Assessment will be conducted to identify any fall-related hazards in the home by the C-PROFET. An Occupational Therapist will discuss with the subject the results and recommended changes to the home to minimize the risk of future falls. A brief follow-up telephone survey will be conducted within three months of the home visit to assess the participant's adherence and barriers to fall prevention recommendations and referral follow-up.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2019
  2. Study start29 Jul 2016
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Why it stopped: Grant applications to fund the investigation were not selected for fundin4.

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03935867
Sponsor's protocol ID
S15-01199
Status last verified
Apr 2019
First submitted
30 Apr 2019
Last updated
13 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Close J, Ellis M, Hooper R, Glucksman E, Jackson S, Swift C. Prevention of falls in the elderly trial (PROFET): a randomised controlled trial. Lancet. 1999 Jan 9;353(9147):93-7. doi: 10.1016/S0140-6736(98)06119-4.

    PubMed 10023893
  • Northridge ME, Nevitt MC, Kelsey JL, Link B. Home hazards and falls in the elderly: the role of health and functional status. Am J Public Health. 1995 Apr;85(4):509-15. doi: 10.2105/ajph.85.4.509.

    PubMed 7702114

Questions about this trial

What is this clinical trial studying?

A study testing C-PROFET in people with Falls Related Risk Factors in the Elderly, run by New York 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 7 inclusion and 2 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: withdrawn, as of the sponsor's last update on 13 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 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 was withdrawn before enrolling participants, so there are no results.

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?

A change in environmental falls-related risk factors in the home (time frame: 3 months). 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 NCT03935867, 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 13 Apr 2022.

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