DOI: 10.3886/e208352v1
title: "Safety in Dementia": An Online Caregiver Intervention.

description: Cognitive and behavioral changes that come with Alzheimer’s Disease and related dementias (ADRD) can increase the risk of injury or death, including from firearms. Suicide is the primary injury risk from firearms for people with ADRD, but ADRD-related confusion or paranoia can put others at risk. In the United States, an estimated 33-60% of people with ADRD have a firearm in the home, and 38% of ADRD caregivers identify firearms as an issue to address. Yet firearm safety is rarely discussed with ADRD patients or caregivers, leaving some ADRD caregivers without guidance about when and how to address the sensitive topic. To address this gap, we developed “Safety in Dementia” (SiD) for informal caregivers to address firearm safety (R34MH113539-NIA suppl). Based on theory and international standards for development, SiD is an online decision aid that helps caregivers clarify values and preferences and then commit to implementing their preferred options. SiD had high acceptability in a small pilot trial, and we hypothesize SiD will increase informal caregivers’ preparation and self-efficacy to make and implement decisions that effectively address firearm access, thereby reducing injury risk. Over a three-year period, our multi-disciplinary, established study team will conduct an online randomized trial of SiD with national recruitment and longitudinal follow-up, with recruitment of informal caregivers of community-dwelling adults with ADRD who have firearm access. Through this trial and qualitative interviews with stakeholders, we aim to: (1) test the efficacy of SiD on firearm safety decision quality and behaviors among a national sample of informal caregivers; (2) compare varied methods (social media/internet versus via relevant organizations) in reaching informal caregivers; and (3) explore stakeholder longitudinal experiences with SiD and firearm-related decisions, including recommendations for optimal SiD use. Our underlying hypotheses are that SiD will be significantly associated with higher immediate decision quality and subsequent action to reduce firearm access, and that caregiver populations will vary by method of contact (social media/internet versus relevant organizations). The proposed research will meet a critical need for effective, acceptable tools to help caregivers address firearm access in the context of ADRD, thereby helping reduce firearm injuries and deaths while respecting and promoting older adult independence, autonomy, and rights. The aging of the U.S. population underscores the urgency of these issues, and our proposed work will provide the scientific foundation for future implementation and evaluation of person-centered tools in real-world settings, including through enhanced understanding of methods for reaching and engaging caregivers.
description: No weights were used
description: Response Rates: Of the 6522 individuals who filled out the screening form, 500 were enrolled (7.7%). Of the total 6522, 3189 did not meet the eligibility criteria (of which 1833 PWD didn't have firearm access, 790 PWD lived in a care facility, 412 individuals were not caregivers of a PWD, 79 PWD did not live in the United states, 49 caregivers did not live in the United States, and 26 caregivers were not 18+), 794 were determined to be scammers/fraudulent screening form, and 254 did not complete the screening form entirely to asses their eligibility. 2285 of the total 6522 were contacted by study staff for an additional screening. 1551 of these were unable to be reached, 131 turned out to not be eligible, 81 were no longer interested. 522 participants were consented to the study, but 22 did not begin the baseline survey and thus were not considered as enrolled.<br>
description: Presence of Common Scales: Attached is the baseline study questionnaire
description: For the study trial, participants will be recruited through two primary methods (social media/internet ads versus relevant organizations), as described below. All advertisements will contain similar messages and will direct individuals to a landing webpage with a description of the study. We will set up separate, identical landing webpages for each recruitment method and subgroup, to allow tracking of overall analytics (e.g., site views) and participation by recruitment modality. Those interested can answer a brief eligibility questionnaire online. Those interested and eligible based on their completion of the brief online eligibility questionnaire, will be contacted by a member of the study team to confirm eligibility. The study team member will contact those that are interested and eligible up to 5 times via phone call, email, and/or text message. Those not interested in the study, or those not eligible, will be directed to an educational website.<br><br>For qualitative interviews, we will invite a sample of ADRD caregivers (n=60) in the Aim 1 trial to enroll in the embedded longitudinal qualitative study. Invitation for qualitative interviews will occur after completion of 2-week follow-up (so as not to affect the key efficacy analyses described above). We will purposively sample caregivers based on key demographics to maximize diversity; demographic factors will include caregiver language, age group, gender, relationship to the person with ADRD, living situation (with or separate from the person with ADRD), geographic region (state and urban/rural location). We will also stratify sampling by recruitment method and trial arm; though we will prioritize conducting relatively more interviews with participants in the SiD arm (to allow discussion of SiD), interviews with control participants will allow us to explore acceptable recruitment approaches (to inform tailored messages and targeted dissemination strategies), as well as the “natural history” of decisions and experiences related to firearms, with a broader cross-section of caregivers. Interviews will be conducted in Spanish for those study participants whose primary, preferred language is Spanish. Key informant interviews with key stakeholders will focus on learning the perspectives of service providers (n=20) who may use the tool in real-world settings (e.g., providers from relevant healthcare settings, caregiver support organizations, and dementia care organizations) and additional experts from key stakeholder groups (n=20), drawing upon suggestions and connections from the study team, Expert Advisory Panel, and NIA officials (e.g., NIA, American Geriatrics Society, the Alzheimer’s Association, the NRA, and the National Shooting Sports Foundation). Snowball sampling will allow us to achieve the target of 20 interviews with key leaders of salient organizations and groups and ensure that we are including those deemed to be trusted experts from a variety of sectors and population perspectives
description: Eligible participants will be adults (≥18 years) living in the United States who speak English or Spanish, are not in legal custody or institutionalized, and who are informal caregivers for a community dwelling person with ADRD and firearm access. Participants must have internet access but do not need to live in the same home (or state) as the person with ADRD, but the person with ADRD cannot live in any type of facility because facilities often have regulations prohibiting firearm possession. Smallest Geographic Unit: United States
description: telephone interview; web-based survey;