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Clinical Trials/NCT05173922
NCT05173922
Completed
Not Applicable

"Safety in Dementia": An Online Caregiver Intervention

University of Colorado, Denver1 site in 1 country500 target enrollmentMay 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caregivers
Sponsor
University of Colorado, Denver
Enrollment
500
Locations
1
Primary Endpoint
Change in Preparation for Decision Making
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 22, 2022
End Date
October 11, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in 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 average of 9 constructs (each ranging from 1, strongly disagree to 5, strongly agree). The scale has high test reliability (0.944) and discriminates significantly between different decision support interventions. In our pilot RCT, participants had a mean score of 3.9 (SD 0.7) after viewing the SiD firearm section.

Secondary Outcomes

  • Change in Decision Self-Efficacy(baseline/pre-intervention, 2 weeks, 2 months, 6 months)
  • Firearm injury(baseline/pre-intervention, 2 weeks, 2 months, 6 months)
  • Change in Firearm access(baseline/pre-intervention, 2 weeks, 2 months, 6 months)
  • Action to reduce firearm access(2 weeks, 2 months, 6 months)
  • Caregiver burden(2 weeks)
  • Positive Aspects of Caregiving(2 weeks)
  • Website analytics(6 months)

Study Sites (1)

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