"Safety in Dementia": An Online Caregiver Intervention

NCT ID: NCT05173922

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-22

Study Completion Date

2024-10-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caregivers Decision Making Alzheimer Disease Social Media Safety Suicide

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Safety in Dementia

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.

Group Type EXPERIMENTAL

Safety in Dementia

Intervention Type BEHAVIORAL

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.

Web control

The control group will view National Institute on Aging Home Safety Checklist.

Group Type ACTIVE_COMPARATOR

Safety in Dementia

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Safety in Dementia

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* In legal custody or institutionalized
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado Anschutz

Aurora, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39531391 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36719721 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-4084

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dementia Family Caregiver Study
NCT04894006 RECRUITING NA