AgingNCT02356211
Longitudinal Outcome in a Veterans Geriatric Multifactorial Falls Assessment Clinic
A study testing Multifactorial Falls Assessment in people with Aging, run by Powers, James S., M.D. at 1 site in United States.
Trial summary
Objective To reduce subsequent falls following Multifactorial Falls Assessment Design: Prospective Case Control Population: Frail elderly Veteran outpatient population referred for falls assessment Methods: Prospective controlled trial of Geriatric Multifactorial Falls Assessment Clinic patients followed for 1 year… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Multifactorial Falls Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Community-dwelling frail elderly with history of fall
Who cannot join
- Severe dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Outcome in a Veterans Geriatric Multifactorial Falls Assessment Clinic: A Prospective Controlled Study
Objective To reduce subsequent falls following Multifactorial Falls Assessment Design: Prospective Case Control
Population: Frail elderly Veteran outpatient population referred for falls assessment
Methods: Prospective controlled trial of Geriatric Multifactorial Falls Assessment Clinic patients followed for 1 year and outcomes compared to Acute Geriatric Evaluation and Management (GEM) Inpatient Unit discharge control group.
Read the detailed description
We designed a prospective controlled trial to compare the effectiveness of outpatient falls assessment and treatment for community-dwelling frail elderly patients with history of falls referred to an active management Geriatric Multifactorial Falls Assessment Clinic with a control group of patients discharged from an Acute Geriatric Evaluation and Management (GEM) Inpatient Unit during the same time period, but who were not specifically referred for falls assessment. We hypothesized that a population of frail elderly referred by their primary care physicians and who reported for evaluation to a Geriatric Multifactorial Falls Assessment Clinic would show a reduction in falls compared to controls, when provided a time-limited consult evaluation with active follow-up for 1 year.
- Conditions
- Aging
- Being tested
- Multifactorial Falls Assessment
- Keywords
- falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial Falls AssessmentOther
Also called Falls Clinic
The Geriatric Multifactorial Falls Assessment Clinic is a component of GERIATRIC-PACT, a frail-elderly primary care patient-centered medical home with care provided by an inter-professional teamlet consisting of a geriatrician, geriatric nurse practitioner, clinical pharmacist, licensed practical nurse, nurse care manager, social worker, and dietitian. GERIATRIC-PACT operates with increased ancillary support compared to Primary Care PACT. Falls assessment patients were referred by primary care providers and were evaluated and treated by the GERIATRIC-PACT teamlet, including ordering of tests and medication adjustment, with an average of two visits and active follow-up for one year.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Geriatric Multifactorial Falls Assessment Clinic Receives: Other: Multifactorial Falls Assessment |
| Control | No intervention | Geriatric Evaluation and Management Service (GEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Falls
Number of participants who experienced falls in 12 months, based on self-recall and telephone interview.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startAug 2008
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Powers, James S., M.D.
- Responsible party
- Principal investigator, James S. Powers, MD, Powers, James S., M.D.
- Investigators
- James Powers, MD, Principal investigator, TVHS GRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356211
- Sponsor's protocol ID
- 840
- Status last verified
- Mar 2020
- First submitted
- 31 Jan 2015
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Per Va IRB, no personal identifiers including age \>89 can be shared. Aggregate data published: Powers JS, Samuels LR, Hu JR, Roumie CL. Veterans Geriatric Multifactorial Falls Assessment Clinic is Associated with Lower Fall Rate . J Gerontology and Aging Research 2017;1:102.
Publications
Michael YL, Whitlock EP, Lin JS, Fu R, O'Connor EA, Gold R; US Preventive Services Task Force. Primary care-relevant interventions to prevent falling in older adults: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2010 Dec 21;153(12):815-25. doi: 10.7326/0003-4819-153-12-201012210-00008.
PubMed 21173416Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. doi: 10.1136/bmj.328.7441.680.
PubMed 15031239Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204. doi: 10.7326/0003-4819-157-3-201208070-00462.
PubMed 22868837Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7. doi: 10.1056/NEJM199409293311301.
PubMed 8078528Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics Society. Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons. J Am Geriatr Soc. 2011 Jan;59(1):148-57. doi: 10.1111/j.1532-5415.2010.03234.x.
PubMed 21226685
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Outcome in a Veterans Geriatric Multifactorial Falls Assessment Clinic: A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT02356211
- Acronym / sponsor ID
- 840
- Conditions
- Aging
- Keywords
- falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Powers, James S., M.D.
- Study start
- Aug 2008
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Posted 31 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective To reduce subsequent falls following Multifactorial Falls Assessment Design: Prospective Case Control
Population: Frail elderly Veteran outpatient population referred for falls assessment
Methods: Prospective controlled trial of Geriatric Multifactorial Falls Assessment Clinic patients followed for 1 year and outcomes compared to Acute Geriatric Evaluation and Management (GEM) Inpatient Unit discharge control group.
Detailed description
We designed a prospective controlled trial to compare the effectiveness of outpatient falls assessment and treatment for community-dwelling frail elderly patients with history of falls referred to an active management Geriatric Multifactorial Falls Assessment Clinic with a control group of patients discharged from an Acute Geriatric Evaluation and Management (GEM) Inpatient Unit during the same time period, but who were not specifically referred for falls assessment. We hypothesized that a population of frail elderly referred by their primary care physicians and who reported for evaluation to a Geriatric Multifactorial Falls Assessment Clinic would show a reduction in falls compared to controls, when provided a time-limited consult evaluation with active follow-up for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Multifactorial Falls AssessmentGeriatric Multifactorial Falls Assessment Clinic |
| Control | No intervention | –Geriatric Evaluation and Management Service (GEM) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Community-dwelling frail elderly with history of fall
Key exclusion criteria (1 listed)
- Severe dementia
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 |
|---|---|---|
| Multifactorial Falls AssessmentAlso: Falls ClinicThe Geriatric Multifactorial Falls Assessment Clinic is a component of GERIATRIC-PACT, a frail-elderly primary care patient-centered medical home with care provided by an inter-professional teamlet consisting of a geriatrician, geriatric nurse practitioner, clinical pharmacist, licensed practical nurse, nurse care manager, social worker, and dietitian. GERIATRIC-PACT operates with increased ancillary support compared to Primary Care PACT. Falls assessment patients were referred by primary care providers and were evaluated and treated by the GERIATRIC-PACT teamlet, including ordering of tests and medication adjustment, with an average of two visits and active follow-up for one year. | Other | Treatment |
Primary outcome
Number of Participants Who Experienced Falls
Time frame: 12 months
Number of participants who experienced falls in 12 months, based on self-recall and telephone interview.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21173416Michael YL, Whitlock EP, Lin JS, Fu R, O'Connor EA, Gold R; US Preventive Services Task Force. Primary care-relevant interventions to prevent falling in older adults: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2010 Dec 21;153(12):815-25. doi: 10.7326/0003-4819-153-12-201012210-00008.
- Results publication: PubMed 15031239Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. doi: 10.1136/bmj.328.7441.680.
- Results publication: PubMed 22868837Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204. doi: 10.7326/0003-4819-157-3-201208070-00462.
- Results publication: PubMed 8078528Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7. doi: 10.1056/NEJM199409293311301.
- Results publication: PubMed 21226685Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics Society. Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons. J Am Geriatr Soc. 2011 Jan;59(1):148-57. doi: 10.1111/j.1532-5415.2010.03234.x.
- Individual participant dataSharing planned: No. Per Va IRB, no personal identifiers including age >89 can be shared. Aggregate data published: Powers JS, Samuels LR, Hu JR, Roumie CL. Veterans Geriatric Multifactorial Falls Assessment Clinic is Associated with Lower Fall Rate . J Gerontology and Aging Research 2017;1:102.
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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.
James Powers, MD principal investigator
TVHS GRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifactorial Falls Assessment in people with Aging, run by Powers, James S., M.D. 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 1 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 10 Mar 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?
Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experienced Falls (time frame: 12 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 NCT02356211, which also lists 5 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 10 Mar 2020.