Alzheimer Disease, Caregivers, Decision Making, Safety, Social Media, Suicide
Conditions
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.
Interventions
BEHAVIORALSafety 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preparation for Decision Making | 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
| Measure | Time frame | Description |
|---|---|---|
| Decision Self-Efficacy | 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). |
| Number of People With Dementia Who Retained Firearm Access | 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 \[0\]) |
| Number of Participants Who Took Action to Reduce Firearm Access for Person With Dementia | 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. |
| Firearm Injury | 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. |
| Caregiver Burden | 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. |
| Positive Aspects of Caregiving | 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. |
Countries
United States
Participant flow
Pre-assignment details
Of N = 522 eligible participants who consented and were sent the survey invitation, N = 22 did not begin the survey or stopped completing the survey before randomization and viewing of the control or Safe at Home information. Therefore, the sample is comprise of N = 500 individuals who were enrolled and randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 30 Participants |
| Age, Categorical Between 18 and 65 years | 202 Participants |
| Age, Continuous | 46.4 years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 428 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Preparation for decision-making | 69.8 units on a scale STANDARD_DEVIATION 22 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 144 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 156 Participants |
| Region of Enrollment United States | 251 participants |
| Sex: Female, Male Female | 162 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 249 | 0 / 251 |
| other Total, other adverse events | 36 / 249 | 31 / 251 |
| serious Total, serious adverse events | 9 / 249 | 11 / 251 |
Outcome results
None listed