"Safety in Dementia": An Online Caregiver Intervention

Alzheimer Disease Clinical Trial

Official title:

"Safety in Dementia": An Online Caregiver Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05173922
• Other study ID #: 21-4084
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2022
• Est. completion date: August 3, 2024

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: August 3, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregivers
• Decision Making
• Dementia
• Safety
• Social Media
• Suicide

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 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 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.	baseline/pre-intervention, 2 weeks, 2 months, 6 months
Secondary	Change in Decision Self-Efficacy	The Decision Self-Efficacy Scale measures confidence in ability to make decisions; transformed scores range from 0 (extremely low) to 100 (extremely high self-efficacy).	baseline/pre-intervention, 2 weeks, 2 months, 6 months
Secondary	Change in 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 analysis, we will use binary categorization (any access to 1+ firearm versus no access to any firearms)	baseline/pre-intervention, 2 weeks, 2 months, 6 months
Secondary	Action to reduce firearm access	This will be self-report of taking action to reduce access to one or more firearms (e.g., locking of additional firearm or moving out of the home). The question and categories will allow identification of smaller, albeit important, changes; for analysis we will use binary categorization (any action versus no action).	2 weeks, 2 months, 6 months
Secondary	Firearm injury	We will assess injuries or near-miss injuries (e.g., threatening situations) 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.	baseline/pre-intervention, 2 weeks, 2 months, 6 months
Secondary	Caregiver burden	The short-form Zarit Burden Interview has scores ranging from 0-48, calculated from the sum of 12 items (measured on a 5-point scale from 0, never to 4, nearly always), with scores over 20 indicating high burden.	2 weeks
Secondary	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 experiences.	2 weeks
Secondary	Website analytics	Outcomes obtained from Google analytics will include average minutes spent on Safety in Dementia and specific pages viewed.	6 months