"Safety in Dementia": An Online Caregiver Intervention

NCT05173922 | Completed Results DMC

• 1 other identifier: 21-4084
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caregivers; Decision Making; Alzheimer Disease; Social Media; Safety; Suicide

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• Decision Self-Efficacy

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

• Number of People With Dementia Who Retained Firearm Access

  2 weeks, 2 months, 6 months

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

  Baseline, 2 weeks, 2 months, 6 months

• Firearm Injury

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

• Caregiver Burden

  2 weeks

Study Arms (2)

Safety in Dementia

EXPERIMENTAL

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.

Behavioral: Safety in Dementia

Web control

ACTIVE COMPARATOR

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

Behavioral: Safety in Dementia

Interventions

Safety in Dementia 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.

Safety in Dementia; Web control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• In legal custody or institutionalized

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 39531391 DERIVED

• 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.

  PMID: 36719721 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Suicide

Interventions

Safety

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Results Point of Contact

• Title: Emmy Betz
• Organization: University of Colorado Anschutz Medical Campus

marian.betz@cuanschutz.edu

720-848-9111

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 30, 2021
• Study Start: May 22, 2022
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: May 14, 2026
• Results First Posted: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)