DementiaSTOP-FALLS-DNCT05777772
Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia
A study testing STOP Falls D Educational Intervention in people with Dementia, run by University of Washington at 1 site in United States.
Trial summary
STOP-FALLS-D is an educational intervention to inform and activate patients, their care partner(s), and their primary care providers to work together to reduce use of central nervous system (CNS) active medications and prevent adverse outcomes (falls and injuries) associated with their use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- STOP Falls D Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 15 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed dementia (dementia diagnosis code or prescription for dementia medication)
- Receiving primary care at a Kaiser Permanente Washington integrated group practice outpatient clinic
- Prescribed at least one CNS-active medication on a chronic (3 months or more) basis
- Aged 18 years or older
- Self-identify as a care partner for the older adult with dementia
Who cannot join
- Skilled nursing facility resident
- Current cancer diagnosis
- On hospice or palliative care
- Care Partner Sample
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Health Research Institute
Seattle, Washington, 98101
About this study
STOP-FALLS-D is an educational intervention to inform and activate patients, their care partner(s), and their primary care providers to work together to reduce use of central nervous system (CNS) active medications and prevent adverse outcomes (falls and injuries) associated with their use.
Read the detailed description
The study design is a pragmatic, one-arm pilot trial to test the feasibility and acceptability of implementing a deprescribing intervention with older people with dementia and their care partners in primary care. The intervention consists of patient-facing educational brochures on CNS-active medications and decision support for the primary care provider. Ethnic/minority groups will be over-sampled to ensure a diverse study sample.
- Conditions
- Dementia
- Being tested
- STOP Falls D Educational Intervention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP Falls D Educational InterventionBehavioural
This is one-arm, health-system embedded pragmatic pilot trial
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Experimental | Educational Intervention Receives: Behavioral: STOP Falls D Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dementia With Medically Treated Falls
Number of older adult participants with dementia with a fall-related healthcare visit
Measured: Through study completion, up to 6 months
Secondary outcomes (2)
Number of Participants With Dementia With All-cause Emergency Department Visits or Hospitalizations
Number of older adult participants with dementia with an emergency department visit or hospitalization for any reason
Measured: Through study completion, up to 6 months
Number of Participants With Dementia With Skilled Nursing Facility Placement
Number of older adult participants with dementia admitted to a skilled nursing facility
Measured: Through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start22 Feb 2023
- Primary completion31 May 2023
- Study completion15 Dec 2023
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.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Elizabeth Phelan, University of Washington
- Investigators
- Elizabeth Phelan, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777772
- Sponsor's protocol ID
- STUDY00015806
- Other IDs
- 3U54AG063546
- Acronym
- STOP-FALLS-D
- Status last verified
- May 2024
- First submitted
- 3 Feb 2023
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT05777772
- Acronym / sponsor ID
- STOP-FALLS-D / STUDY00015806
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Posted 7 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STOP-FALLS-D is an educational intervention to inform and activate patients, their care partner(s), and their primary care providers to work together to reduce use of central nervous system (CNS) active medications and prevent adverse outcomes (falls and injuries) associated with their use.
Detailed description
The study design is a pragmatic, one-arm pilot trial to test the feasibility and acceptability of implementing a deprescribing intervention with older people with dementia and their care partners in primary care. The intervention consists of patient-facing educational brochures on CNS-active medications and decision support for the primary care provider. Ethnic/minority groups will be over-sampled to ensure a diverse study sample.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Experimental | Behavioral: STOP Falls D Educational InterventionEducational Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed dementia (dementia diagnosis code or prescription for dementia medication)
- Receiving primary care at a Kaiser Permanente Washington integrated group practice outpatient clinic
- Prescribed at least one CNS-active medication on a chronic (3 months or more) basis
- Aged 18 years or older
- Self-identify as a care partner for the older adult with dementia
Key exclusion criteria (4 listed)
- Skilled nursing facility resident
- Current cancer diagnosis
- On hospice or palliative care
- Care Partner Sample
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 |
|---|---|---|
| STOP Falls D Educational InterventionThis is one-arm, health-system embedded pragmatic pilot trial | Behavioural | Educational Intervention |
Primary outcome
Number of Participants With Dementia With Medically Treated Falls
Time frame: Through study completion, up to 6 months
Number of older adult participants with dementia with a fall-related healthcare visit
2 secondary outcomes
Number of Participants With Dementia With All-cause Emergency Department Visits or Hospitalizations
Time frame: Through study completion, up to 6 months
Number of Participants With Dementia With Skilled Nursing Facility Placement
Time frame: Through study completion, up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elizabeth Phelan, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOP Falls D Educational Intervention in people with Dementia, run by University of Washington 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 5 inclusion and 4 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 7 May 2024. 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 7 May 2024). 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 With Dementia With Medically Treated Falls (time frame: Through study completion, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.