Back to results"Safety in Dementia": An Online Caregiver Intervention
Primary Purpose
Caregivers, Decision Making, Alzheimer Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety in Dementia
Sponsored by
About this trial
This is an interventional prevention trial for Caregivers
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
Sites / Locations
- University of Colorado AnschutzRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Safety in Dementia
Web control
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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)
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).
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.
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.
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.
Website analytics
Outcomes obtained from Google analytics will include average minutes spent on Safety in Dementia and specific pages viewed.
Full Information
NCT ID
NCT05173922
First Posted
November 17, 2021
Last Updated
September 25, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05173922
Brief Title
"Safety in Dementia": An Online Caregiver Intervention
Official Title
"Safety in Dementia": An Online Caregiver Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers, Decision Making, Alzheimer Disease, Social Media, Safety, Suicide
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Safety in Dementia
Arm Type
Experimental
Arm Description
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.
Arm Title
Web control
Arm Type
Active Comparator
Arm Description
The control group will view National Institute on Aging Home Safety Checklist.
Intervention Type
Behavioral
Intervention Name(s)
Safety in Dementia
Intervention Description
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 Outcome Measure Information:
Title
Change in Preparation for Decision Making
Description
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.
Time Frame
baseline/pre-intervention, 2 weeks, 2 months, 6 months
Secondary Outcome Measure Information:
Title
Change in Decision Self-Efficacy
Description
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).
Time Frame
baseline/pre-intervention, 2 weeks, 2 months, 6 months
Title
Change in Firearm access
Description
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)
Time Frame
baseline/pre-intervention, 2 weeks, 2 months, 6 months
Title
Action to reduce firearm access
Description
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).
Time Frame
2 weeks, 2 months, 6 months
Title
Firearm injury
Description
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.
Time Frame
baseline/pre-intervention, 2 weeks, 2 months, 6 months
Title
Caregiver burden
Description
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.
Time Frame
2 weeks
Title
Positive Aspects of Caregiving
Description
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.
Time Frame
2 weeks
Title
Website analytics
Description
Outcomes obtained from Google analytics will include average minutes spent on Safety in Dementia and specific pages viewed.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marian E Betz, MD, MPH
Phone
3035505669
Email
marian.betz@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Anschutz
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marian Betz, MD, MPH
Email
marian.betz@cuanschuzt.edu
First Name & Middle Initial & Last Name & Degree
Emily Greenway, MPH
Phone
8643534697
Email
emily.greenway@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Marian Betz, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
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"Safety in Dementia": An Online Caregiver Intervention
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