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CaregiversNCT05173922

"Safety in Dementia": An Online Caregiver Intervention

A study testing Safety in Dementia in people with Caregivers and Decision Making, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In an online randomized trial of Safety in Dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of community-dwelling adults with dementia who have firearm access. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Caregivers, Decision Making, Alzheimer Disease
What is being tested?
Safety in Dementia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
22 May 2022to 11 Oct 2024
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Live in United States
  • Speak English or Spanish
  • Informal caregiver for community swelling person with dementia and firearm access
  • Access to the internet

Who cannot join

  • In legal custody or institutionalized

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Anschutz

    Aurora, Colorado, 80045

Other trials in United States

About this study

In an online randomized trial of Safety in Dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of community-dwelling adults with dementia who have firearm access.

Read the detailed description

Aim 1: To test the efficacy of Safety in Dementia (SiD) on firearm safety decision quality and behaviors, among a national sample of informal caregivers of community-dwelling people with dementia and firearm access (n=500).

Aim 2: To compare varied methods in reaching informal caregivers. Aim 3: To explore stakeholder longitudinal experiences with SiD and firearm-related decisions.

Being tested
Safety in Dementia
Medical subject headings
Alzheimer Disease, Suicide

What participants receive

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

  • Safety in DementiaBehavioural

    Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist.

Study groups in NCT05173922
Study groupRoleWhat they receive
Safety in DementiaExperimentalSafety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan.
Receives: Behavioral: Safety in Dementia
Web controlActive comparatorThe control group will view National Institute on Aging Home Safety Checklist.
Receives: Behavioral: Safety in Dementia

What is being measured

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

  1. Preparation for Decision Making

    The Preparation for Decision Making Scale assesses perception of how useful a decision aid is in preparing for subsequent decision-making. Scores range from 1-5, calculated from the sum of 10 constructs (each ranging from 1, 'not at all' to 5, 'a great deal'). The total score is calculated by first summing the 10 items and dividing by 10 to find an average item response score. Then, we subtract 1 from the summed score and multiply this by 25 to convert the final score to a 0-100 scale with higher scores indicating higher perceived levels of preparation for decision making (higher = better).

    The scale has high test reliability (0.944) and discriminates significantly between different decision support interventions.

    Measured: During baseline assessment (specifically, after receiving randomization allocation), 2 weeks, 2 months, 6 months

Secondary outcomes (6)

  1. Decision Self-Efficacy

    The Decision Self-Efficacy Scale measures confidence in ability to make decisions; transformed scores range from 0 (extremely low, worst outcome) to 100 (extremely high self-efficacy, best outcome).

    Measured: baseline/pre-intervention, 2 weeks, 2 months, 6 months

  2. Number of People With Dementia Who Retained Firearm Access

    Firearm access for the person with ADRD will be assessed with scales we have used in prior work, allowing nuanced (but efficient) description of firearm access (on a scale ranging from access to multiple loaded firearms to no access to any firearms). For reporting and analysis, we will use binary categorization (caregiver reports that person with dementia still has access to 1+ firearm [1] versus person with dementia no longer has access to any firearms [0])

    Measured: 2 weeks, 2 months, 6 months

  3. Number of Participants Who Took Action to Reduce Firearm Access for Person With Dementia

    At each time point, participants self-reported if they have taken any steps to reduce firearm access for the person with dementia. Nine response options associated with this question are used to calculate this binary outcome (1+ actions taken versus no action taken). If they selected 'yes' to any of the following options, their outcome was '1+ action taken' (1); if they selected 'no' to all, their outcome was 'no action taken' (0). The nine response options were: (1) used a/more locking devices, (2) used a/more locking safes or gun lockboxes, (3) gave a/more guns to a trusted family member for temporary safekeeping, (4) gave a/more guns to a trusted friend for temporary safekeeping, (5) stored a/more guns at a store or range that has firearm storage, (6) stored a/more guns at a law enforcement agency temporarily, (7) gave a/multiple guns to law enforcement permanently, (8) sold, gave or transferred a/multiple guns to family or friends, and (9) sold a/multiple guns to the public.

    Measured: Baseline, 2 weeks, 2 months, 6 months

  4. Firearm Injury

    We will assess injuries involving the person with ADRD and a firearm. Participants will be asked about any such incidents in the prior year (baseline) or since enrollment (follow-up) and a brief description.

    Measured: baseline/pre-intervention, 2 weeks, 2 months, 6 months

  5. Caregiver Burden

    The short-form Zarit Burden Interview has scores ranging from 0-48, calculated from 12 items (measured on a 5-point scale from 0, never to 4, nearly always); scores range from 0 to 12 with higher scores reflecting higher burden.

    Measured: 2 weeks

  6. Positive Aspects of Caregiving

    The Positive Aspects of Caregiving Scale has scores ranging from 0-36, calculated from the sum of 9 items (measured on a 5-point scale ranging from 0, disagree a lot, to 4, agree a lot, on statements such as feel more useful), with higher scores indicating more positive caregiving experiences.

    Measured: 2 weeks

Timeline

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

  1. First posted30 Dec 2021
  2. Study start22 May 2022
  3. Primary completion11 Oct 2024
  4. Study completion11 Oct 2024

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05173922
Sponsor's protocol ID
21-4084
Status last verified
May 2026
First submitted
17 Nov 2021
Last updated
14 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Betz ME, Portz J, Knoepke C, Ranney ML, Fischer SM, Peterson RA, Johnson RL, Omeragic F, Castaneda M, Greenway E, Matlock D. The Effect of the "Safety in Dementia" Online Tool to Assist Decision Making for Caregivers of Persons With Dementia and Access to Firearms : A Randomized Trial. Ann Intern Med. 2024 Dec;177(12):1630-1640. doi: 10.7326/ANNALS-24-00763. Epub 2024 Oct 22.

    PubMed 39531391

  • McCarthy V, Portz J, Fischer SM, Greenway E, Johnson RL, Knoepke CE, Matlock DD, Omeragic F, Peterson RA, Ranney ML, Betz ME. A Web-Based Decision Aid for Caregivers of Persons With Dementia With Firearm Access (Safe at Home Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 31;12:e43702. doi: 10.2196/43702.

    PubMed 36719721

Questions about this trial

What is this clinical trial studying?

A study testing Safety in Dementia in people with Caregivers and Decision Making, run by University of Colorado, Denver 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 4 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 14 May 2026. 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 14 May 2026). 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?

Preparation for Decision Making (time frame: During baseline assessment (specifically, after receiving randomization allocation), 2 weeks, 2 months, 6 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 NCT05173922, 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 14 May 2026.

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