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Completed

NCT Number: NCT05173922

"Safety in Dementia": An Online Caregiver Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Preparation for Decision Making

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

    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.

Secondary outcomes

  1. Decision Self-Efficacy

    Time frame: baseline/pre-intervention, 2 weeks, 2 months, 6 months

    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).

  2. Number of People With Dementia Who Retained Firearm Access

    Time frame: 2 weeks, 2 months, 6 months

    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])

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

    Time frame: Baseline, 2 weeks, 2 months, 6 months

    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.

  4. Firearm Injury

    Time frame: baseline/pre-intervention, 2 weeks, 2 months, 6 months

    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.

  5. Caregiver Burden

    Time frame: 2 weeks

    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.

  6. Positive Aspects of Caregiving

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 30, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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