Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05173922
Other study ID # 21-4084
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT04079803 - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients Phase 2
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT04520698 - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease N/A
Active, not recruiting NCT04606420 - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease N/A
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Terminated NCT03672474 - REGEnLIFE RGn530 - Feasibility Pilot N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Recruiting NCT04949750 - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease N/A
Recruiting NCT05557409 - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation Phase 3
Recruiting NCT04522739 - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease Phase 4
Recruiting NCT05288842 - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Completed NCT06194552 - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07 Phase 1
Completed NCT03239561 - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants Early Phase 1
Completed NCT03184467 - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients Phase 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated NCT03487380 - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT05328115 - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease Phase 1
Completed NCT05562583 - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support N/A