Abstract
Background and Objective
Dementia clinical research studies have difficulty recruiting and enrolling participants and their study partners. Through convening and working with a community advisory board and the incorporation of the perspectives of people living with dementia and caregivers, this study utilized a community-engaged approach to identify factors affecting dementia clinical research participation.
Methods
In this qualitative study, 24 participants (12 people living with dementia and 12 caregivers), half of whom participated in dementia clinical research, were interviewed. Deductive and inductive approaches to thematic analysis were conducted to identify themes.
Results
Ten themes were organized into two categories. Factors affecting ability to participate include symptom recognition and diagnosis, knowledge of opportunities, ineligibility/disenrollment, time/distance, caregiver burden, and online searches for study opportunities. Factors affecting willingness to participate include helping others, living life to the fullest, caregiver support, and taking study drugs.
Conclusions
When combined with a reframing of factors affecting dementia clinical research enrollment within the context of ability and willingness to participate, these findings may be useful for elucidating factors and developing strategies to enhance participation in clinical research and advance efforts dedicated to finding effective treatments for dementia.
Key Points
| A multitude of factors, such as knowledge of opportunities and caregiver support, affect ability and willingness to participate in dementia clinical research. |
| Barriers affecting ability and willingness to participate in dementia clinical research can be mitigated by health providers, research organizations and sponsors, and policy makers. |
| Based on their lived experiences, incorporating people with dementia and their caregivers into the study design process may lead to more effective recruitment strategies. |
Introduction
Over 6.5 million people in the United States are diagnosed with dementia, a disease with no cure [1]. Identifying effective clinical therapies for dementia has been challenging and, for the most part, unsuccessful [2]. Advancements in dementia research are in part contingent on participation in clinical research. This qualitative study uses the National Institutes of Health definition of clinical research, which is “medical research involving people to test new therapies and treatments” and includes drug and non-drug clinical trials and natural history studies [3].
However, it is challenging to reach target enrollment for these studies [1, 4, 5]. Over 70% of people with dementia are excluded from drug trial participation due to comorbidities, incompatible medications, low cognition scores, and/or frailty [1, 4–6]. Some who are eligible for drug trials and other studies may choose to participate because of the potential benefits for themselves or others [5–10]. Others may be unwilling to participate in research due to concerns about risk, stigma, or time required to conduct study activities [1, 4, 8–10]. Further, people with dementia and caregivers may be unaware of available research studies [1, 5, 6, 11]. Additionally, in the United States, study partners (typically family members) are required to participate in research with the person with dementia to ensure protocol adherence and appointment attendance [1, 4–12]. This can also complicate the recruitment process by adding more demands to caregivers who may already experience burden [1, 5, 6, 8, 11], or not have the same interest in participating as the person with dementia [12, 13].
To increase participation in dementia clinical research, the National Institute on Aging (NIA) released a national strategy for improving research participation in dementia studies, including continued research on identifying barriers and facilitators to participation and inclusion of people with dementia and caregivers in research decision-making processes [1]. Many studies identifying factors affecting dementia clinical research recruitment do not include those with lived experience of dementia [4, 14]. Studies that ask caregivers and people with dementia about their decisions to participate in clinical research often recruit from existing research cohorts [6–9, 12–15]. In addition to the NIA, there are calls for the inclusion of people with dementia and caregivers in discussions related to factors regarding, and strategies for, dementia research recruitment [16–18].
The purpose of this study is to identify factors affecting dementia research participation through the incorporation of perspectives of people with dementia and family caregivers as experts, using the Portland, Oregon metropolitan area as a case example and as part of a dissertation study. Here we report on the findings from these experts and how they can be conceptualized and implemented into robust strategies for improving dementia clinical research participation.
Methodology
This qualitative study used a community-engaged approach to identify specific factors and strategies that affect research participation by persons with dementia and their family caregivers [4]. This approach recognized these individuals as experts and aimed to enhance the study’s rigor, relevance, and reach [19]. A community advisory board (CAB) was constituted specifically to guide the study. The CAB consisted of dementia researchers, providers, advocates, people with dementia, family caregivers, older African Americans (who are more likely to be diagnosed with dementia but less likely to participate in dementia clinical research [1]), and a member of the lead author’s dissertation committee with expertise in community-engaged research. The CAB met three times during the study to review and modify recruitment materials and data collection tools. They also provided member-checking and interpretation of findings. People with dementia, caregivers, and older African Americans received a $30 grocery store gift card for each meeting.
Participants were recruited through memory cafes, caregiver support groups, and a local research organization. To be eligible for the study, all participants were required to speak fluent English and have lived, received care, or participated in a dementia clinical research study in the Portland metropolitan area. People with dementia needed to report (themselves or their caregiver) a clinical diagnosis ranging from mild cognitive impairment (MCI) to moderate dementia, with minimal impairment in verbal fluency. Individuals with dementia who did not have a caregiver were excluded.
Data Collection and Analysis
Research protocols were reviewed and approved by the Portland State University Institutional Review Board (IRB #184914) and interview guides and questionnaires were reviewed and approved by the CAB and the lead author's dissertation chair. All interviewees provided written informed consent.
The lead author, then a doctoral candidate, conducted 24 semi-structured interviews with people with dementia (n = 12) and their family caregivers (n = 12). All interviews took place in the interviewees’ homes between August and December 2019, at which point data saturation [20] and an equal number of people who had or had not participated in research was reached.
Questions were derived from the literature and previous research conducted by the lead author. Topics included symptom recognition and diagnosis, knowledge of dementia research studies, perceptions of research, factors that improve or reduce the likelihood of participation of dementia research studies, and suggestions they had for improving the likelihood of dementia research participation. Those who had participated in dementia research were asked to describe their experiences. Separate interview guides for the person with dementia and caregiver were developed as the introductions were different and some question wording varied for the person with dementia (e.g. “When did you first notice signs of MCI/ADRD?”) and the caregiver (e.g. “When did you first notice signs of MCI/dementia in <person living with ADRD/MCI>?”) (ADRD: Alzheimer's disease and related dementias.) Interviewees also reviewed a form with a list of factors affecting dementia research participation, collected from researchers, healthcare providers, and advocates in earlier research [11]. These factors were broadly categorized into two themes related to factors affecting ability and motivation to join research. In cases where an interviewee was confused or needed examples, the interviewer provided examples. Neither the interview guides nor the form changed throughout the duration of the study. All data collection tools are included in the electronic supplementary material (ESM).
Persons with dementia and their family caregivers were interviewed separately to ensure that both could answer the questions freely without concern about, or input from, the other person. If requested, caregivers were present during the persons with dementia interviews, but were asked to limit engagement during the interview. Only one person with dementia preferred that their caregiver stay with them during their interview.
Caregivers were interviewed first to obtain detailed information about symptom recognition and diagnosis, and research participation, if applicable. These details were used as prompts, as relevant, for the interviews with people with dementia. Caregivers also reviewed the form with the interviewer and noted whether they agreed with each factor listed and why. People with dementia received the form and were given the opportunity to review and complete it ahead of their own interview. Participants with dementia were interviewed after the caregivers. If review of the form was completed ahead of time, the interviewer read aloud their response and asked the person with dementia to elaborate. If they did not complete the form, the form was reviewed in the same manner as for the caregiver.
Interviews were audio-recorded, and the investigator took field notes during and after interviews. Interviews were de-identified and transcribed, then uploaded to Atlas.ti 8.1 software [21]. Using thematic analysis [22], the transcripts and field notes were examined for common codes which were informed by the investigator’s knowledge of theories and literature. Codes included sentences or sentence fragments that represented data and concepts [20]. Much of the analysis was deductive, and codes were analyzed for alignment with concepts and theories derived from the literature [20], such as ‘diagnosis,’ ‘study knowledge,’ or ‘traveling’. An inductive approach was then used to code for themes that did not correspond with existing literature and theories to identify themes that emerged organically. This mitigated the possibility of coding those themes based on current literature rather than the interviews [20]. The lead author was the primary coder. Themes were discussed with the lead author’s dissertation committee and the CAB. Deliberation focused on important themes and subthemes, as well as novel concepts or missing points.
Results
The study sample consisted of 24 participants: 12 people with MCI or dementia and their family caregivers. Six of the dyads (50%) had had experience participating in dementia research studies. All twelve caregivers were family members; ten were spouses and two were adult children (Table 1).
Table 1.
Characteristics of interviewees with dementia and caregivers
| Person with dementia (n = 12) | Caregivers (n = 12) | |
|---|---|---|
| Female (%) | 58.3 | 50.0 |
| Participated in clinical research (%) | 50.0 | 50.0 |
| Alzheimer’s disease (%) | 66.7 | N/A |
| MCI (%) | 16.7 | |
| Mixed or other dementia (%) | 16.7 | |
| Years with diagnosis (range) | 1.0–5.0 |
MCI: mild cognitive impairment
Results of people with dementia and caregivers are reported together as all themes were present in the accounts of both people living with dementia and of family caregivers. The key thematic findings are summarized in Table 2, organized into two categories and 10 themes.
Table 2.
Themes and subthemes from interviews
| Category | Themes |
|---|---|
| Factors affecting the ability to participate in research |
Symptom recognition and diagnosis Knowledge of opportunities Ineligibility/disenrollment Time/distance Caregiver burden Online searches for study opportunities |
| Factors affecting willingness to participate in research |
Helping others Living life to the fullest Caregiver support Taking study drugs |
Factors Affecting Ability to Participate in Research
People with dementia and caregivers described similar factors affecting their ability to enroll in a study regardless of their participation status. Factors included symptom recognition and diagnosis, knowledge of opportunities, ineligibility or disenrollment, time spent and distance traveled for the study, caregiver burden, and Internet use. These factors are discussed in detail below.
Symptom Recognition and Diagnosis
Several people with dementia were able to identify a specific event or multiple incidents where they recognized symptoms, such as being unable to get things done at work. Those who recounted substantive signs of memory changes, such as trouble driving, also noted that they received a diagnosis relatively quickly. Others with early symptoms recalled feelings of dismissiveness from their providers. They also stated that it sometimes took years to get a diagnosis.
Person with Dementia 8: “I knew that there were some issues. So I went to my family physician and I said, “You know, I just can’t remember things like I used to.” And he just discounted it … So then I spent another few years after that and it just kept continuing to get worse.”
Neither individual with MCI had a confirmed Alzheimer’s disease diagnosis but believed they had progressed to it based on contextual clues, such as the need to have an Alzheimer’s disease diagnosis to be accepted into a drug trial. Some individuals with dementia noted that their diagnosis was somewhat positive not only because cognitive and behavioral changes were explained, but it also allowed them to begin searching for clinical research opportunities.
Person with Dementia 9: “[Husband] gets online and he said, ‘Okay. As far as I can see, the best place on the West Coast to go is [research organization].’ … Then I [entered] a clinical trial down there.”
Knowledge of Study Opportunities
Awareness of study opportunities varied. Those who participated in studies learned of them via brochures in their neurology clinic, a friend’s referral, a referral through an Alzheimer’s Association support group, and/or online research. Some caregivers asked their clinician or support groups about opportunities, but these sources were either unaware of any or unfamiliar with what was available, and/or told the caregivers to check their organization’s website. Other interviewees had never heard of opportunities. In the present study, four dyads directly asked the lead author during their interview if she could provide them with information about available studies.
Caregiver 8: “I had asked our primary care physician. She did not recommend any particular person to contact … Then we have a friend [who] knew I wanted to get [wife] in, so he gave me the contact person at [research organization].”
Person with Dementia 3: “It has never come up. [They] haven't asked me. You're the first one ... I don't know of any other research.”
Several interviewees noted they had heard of studies but decided not to learn more for a variety of reasons. These are discussed later in this paper.
Ineligibility/Disenrollment
Two people with dementia who participated in research noted they were ineligible for other studies for which they had previously screened. One was ineligible because of scoring too high on cognitive tests. The second was ineligible because of age. A third person with dementia was disenrolled after enrolling and receiving the study drug.
Caregiver 10: “[Wife] got a drug ... and it was wonderful … And then, she tested out of the group … Because they were only looking at a certain parameter, and she was above the parameter. She … [was] not happy when this was taken away from her. It really had been a help."
None of the six dyads who had not participated in research reported being told that they were ineligible, though one speculated that was the case.
Caregiver 6: “I’ve put her name on a couple of different [registries], where they’re asking for research subjects, but nobody’s ever contacted us. So, evidently she didn’t meet the criteria.”
Time and Distance
Time spent on research activities and driving distance for study activities were major factors for many caregivers and people with dementia. Most noted that driving to the various study sites affected their decision to participate in research.
Caregiver 10: “We drive out [across town] for an optometry appointment, and have to drive back, and … that was what really put her off. And me, too … they had one place for CT and one place for MRI … [and then a third place for] optometry … [Then] she had a hearing test at another place.”
One couple who drove 2 hours one way every month for study activities had a different outlook on the time and distance they spent in the study.
Caregiver 9: “It's just something we plan on. Sometimes we just go up for the day, sometimes we meet friends and spend the night. It's a day, you spend three or four hours sitting in a chair … We have a little routine, we listen to [podcasts] or music. We have our favorite restaurants that we go to. So it’s not difficult at all.”
Caregiver Burden
Some caregivers noted the demands of caregiving affected their ability to participate in research.
Caregiver 4: “It's just a significant effort to do anything other than kind of hang around the house.”
Caregivers also noted how their responsibilities affected their ability to participate, even if they were not required to travel for study activities.
Caregiver 3: “One I thought about doing seemed very easy because we didn't have to go anywhere … But the thought of using [the technologies], it would have been a headache trying to explain, ‘Oh, this is for this,’ constantly ... I'm already answering questions all the time, and then to add something else ...”
Online Searches for Study Opportunities
Several caregivers did online research to find studies; while some were able to find study opportunities and registries, others noted the complexities of navigating the information.
Caregiver 6: “You get on these websites, and a lot of times they're in fairly scientific terms, which for the most part, I can read and decipher. Most people can't … Not everybody is computer-literate.”
Factors Affecting Willingness to Participate in Research
All interviewees believed research was essential and more people needed to participate; however, that sentiment did not necessarily mean they were willing to join a study. Factors derived from these interviews included motivation to help others, living life to the fullest, and taking study drugs.
Motivation to Help Others
Nearly everyone interviewed recognized that dementia clinical research participation might not be beneficial for themselves, although some noted that they hoped they would see a benefit if they participated. Rather, they participated or said they would consider participating to help others or give back to society in some way.
Person with Dementia 10: “I always felt it was my duty to do it. So that’s why I did it for as long as I did … Because if I was suffering, I knew others were as well. I really felt like this was a fight worth going into.”
For some, not receiving a direct therapeutic benefit was a sufficient reason to not participate in available studies.
Caregiver 5: “I don’t think there’s going to be anything that’s going to reverse it… And I know that it could help people in the future. … But, … to drive up to [research organization], which is way the heck up there, and for what?”
Living Their Life to the Fullest
Several interviewees felt that having dementia was a “race against the clock” before they were no longer able to do what they enjoyed. Many believed they had limited time to live their lives to the fullest, and if they had to choose between participating in a study and doing things they enjoyed, they would choose the latter.
Person with Dementia 4: “I would prefer [a research study] not take so much time. I can't work on [hobbies] because I really feel that I don't have that much time [for them].”
Taking Study Drugs
When interviewees were asked how they would describe clinical research, most defined it in terms of drug trials—testing a study drug to determine if it is effective for treating or preventing a disease. For ten interviewees, taking a study drug was an automatic disincentive to joining a study. Some interviewees alluded to having physical difficulty swallowing pills, while others noted concerns about safety, effectiveness, or side effects. Very few indicated that they would be willing to participate in pharmacologic studies even though safety and efficacy had already been established.
Caregiver 4: “If the only research options were medication, I don't think that would [work] ... He has enough trouble taking [his] medications.”
Caregiver Support
Several caregivers felt unsupported. Although they acknowledged that it was not the researcher’s ‘role’ to provide support, they noted that it could be a motivator for caregivers to join a study.
Caregiver 3: “They probably know a caregiver's under a lot of pressure. So ease some of that pressure and you might help with participation … They could provide a caregiver and compensation for a couple of hours. They could have an activity that we could drop the person off at another time. They could help deal with any issues you're dealing with your person in particular. That's not their role, but those are useful things.”
One caregiver noted that they report on their emotional health every week as part of their study participation and wanted resources in acknowledgement of their responses:
Caregiver 1: “You know, [my survey responses] are all going into a big file in a computer, and you think, "Here I am pouring out my heart about how lonely I was”… So, if I say I'm lonely, just lend me an ear, and give me wisdom about how to deal with this.”
Discussion
These findings mirror those of other authors but provide further qualitative insights into the reasons behind a decision to participate in dementia clinical research or not. The insights also come from people with dementia and caregivers who are not part of existing research cohorts, which differs from the samples included in previous studies. This is in part due to the CAB’s suggestions of places to recruit at and modifications to study recruitment materials. Findings are described in detail hereafter.
First, there is a lack of knowledge among study participants about opportunities for participation in dementia research. Several caregivers and people with dementia were unaware of available study opportunities, even in cases where they had searched for them by asking their health professional or signing up for dementia study registries. While this is discussed frequently in the literature [1, 5, 6, 11], it was surprising here because most of these interviewees were recruited for this study from organizations with rich knowledge of research opportunities. Some interviewees noted they needed a high level of scientific understanding to search for dementia research online, as well as the time to search or sign up for registries. These factors, in addition to needing Internet literacy, made it difficult for many interviewees to use the Internet as a means for finding study opportunities. Not having the information needed to learn about available studies reduced interviewees’ ability to participate in research.
Second, the findings suggest that the personal value or benefit of dementia research did not affect the decision to join studies. Interviewees who participated in research, and those who wanted to, recognized that their participation would not result in a direct therapeutic benefit to help themselves but might help friends, family, future generations, others with dementia, or generally contribute to science. A person with dementia or a caregiver might be motivated to participate in dementia research, but some people with dementia and caregivers believed they only had a few years left before the disease progressed too far to fully enjoy life. In these cases, they decided not to participate in studies because this could take away from their perceived limited time remaining to live their lives to the fullest while they still could. Additionally, many interviewees noted there were significant constraints on their ability to participate in research, most notably caregiver burden and time and distance to travel. This aligned with findings from the literature that articulate the lack of a relationship between hypothetical and actual willingness to be in a study [5, 6, 11].
Third, many caregivers in this study indicated they would be motivated to volunteer themselves, and the person they were caring for, for study opportunities if they received something tangible to better manage caregiver stress. The literature about dementia study partners and caregivers describes caregiver support as a facilitator to study participation [5, 6, 8]. However, some organizations may be unable to provide supports because of a lack of resources or because of concerns these actions might compromise the integrity of the research.
Fourth, several caregivers and people with dementia noted that they avoided research because it required the person with dementia to take study drugs. For some, this requirement was an automatic ‘deal-breaker’ due to their dislike of taking medications. Others were concerned about the potential risks of taking an untested drug. This aligns with evidence in the literature [1, 5, 6, 8].
Lastly, in some cases, there was miscommunication surrounding eligibility criteria. Both people with MCI and their caregivers assumed a progression from a diagnosis of MCI to dementia because of their participation in an Alzheimer’s disease clinical trial, despite never receiving confirmation of this advanced diagnosis from their provider or researcher. One dyad was distressed by their discontinuation in a study that provided a direct benefit because the participant scored higher than permitted on one parameter. These examples present ethical issues regarding communication, ensuring participants are fully aware of what makes them eligible or ineligible throughout the study, and what exclusion criteria are necessary to ensure safe participation. This discussion is important but outside the scope of this study.
Recommendations for Increasing Dementia Clinical Research Participation
The factors affecting ability and willingness to participate in dementia clinical research can be addressed by research organizations and dementia healthcare providers, study sponsors, and policy makers. Strategies that are implemented should be routinely evaluated to determine their feasibility and effectiveness.
First, research organizations could collaborate with study sponsors to reduce the time spent in, and distance traveled for, study activities. For instance, researchers could work with local healthcare providers to offer centralized sites for all study activities, offer phone or videoconference assessments, or offer multiple study sites so participants could choose their preferred site. The COVID-19 pandemic has demonstrated the acceptability and uptake of multiple video-based platforms for telehealth and personal communication. Researchers could also seek to provide in-home study opportunities, such as working with home care nurses to provide infusions instead of requiring visits to the study site.
Second, researchers can partner with other healthcare and resource providers to disseminate and promote study opportunities to enhance recruitment. Not all non-participant interviewees noted high transaction costs. Several interviewees had attempted to learn more about research opportunities but were unaware of studies, and would have participated if offered the opportunity. Organizations could modify their rules or processes to increase the likelihood of turning ability and willingness into participation. If a person with dementia or a caregiver is unaware of studies, they are unable to participate. Researchers could refocus their recruitment efforts and provide flyers, newsletter write-ups or give presentations in places where people with dementia and caregivers congregate, such as support groups, memory cafes, or respite and day centers (many of which were curtailed during the height of the COVID-19 pandemic but have resumed operations). Researchers could also highlight the benefits of helping others as an altruistic incentive to participate.
Third, researchers could partner with research participants to share the experience of participation in research and discuss the benefits of being a research participant with local community members. Many interviewees noted they participated for the ultimate benefit of others, rather than themselves, and they derived happiness from doing so. These messages can also include the differences among clinical research and clinical trials, study drug versus non-study drug clinical trials, and the phases of clinical trials. For example, many studies do not involve drugs, instead focusing on neuroimaging, dietary interventions, exercise, social engagement, natural histories, and observational or interventional technology. Sharing knowledge of these opportunities with those who are hesitant of study drug trials may lead to greater participation in non-drug dementia clinical research studies.
Fourth, knowledge of study opportunities could also be fostered by modifying both national and local online registries and clinical research websites. These sites and registries, including national, local, or disease- or organization-specific registries, offer a wealth of information about study opportunities but may be inaccessible to those who lack scientific literacy or Internet expertise. Modifications may include using lay language, providing definitions to describe trials, and streamlining navigation and registration processes. One example is the Association for Frontotemporal Degeneration’s website, which is easily navigable, written in lay language, provides definitions of different types of clinical research, shares information about active studies, and invites people to sign up for different FTD-related registries [23].
Fifth, research organizations could modify how they articulate their view of caregivers. If participation of a study partner is a requirement for participation in a study by a person with dementia, then the caregivers are also participants who perform different study roles and activities. By reconceptualizing caregivers as participants rather than study partners, research organizations could provide compensation in a manner that is most suitable to caregivers (e.g. offer caregiver supports), yet reflective of what the organization can feasibly provide based on their resources. Researchers could budget for this compensation in grant proposals and/or seek supplemental funding. Research organizations can also facilitate engagement by family caregivers themselves; for example, caregiver intervention studies using the telephone or videoconferencing are increasingly more common [24–26].
Limitations
This study had several limitations. Sampling bias is likely. Sociodemographic information was not collected, with the exception of gender information identified at the time of eligibility. Race and ethnicity data were not collected; as a result, these findings may be less relevant to people of color with dementia and their caregivers. These findings are specific to the Portland, Oregon metropolitan area. Additionally, this sample only included English-speaking persons due to the author’s language ability. The findings may be contextually relevant for similar communities but are not necessarily generalizable nor are they intended to be. However, these findings may be transferable to researchers, clinicians, or advocates in other metropolitan areas if they believe these findings are applicable to their setting and specific context [27].
Further, this sample was limited by only including people with dementia who had caregivers. The authors chose to include this eligibility criteria as study partners are instrumental to participation in clinical research in the United States. However, this serves as a limitation and may further perpetuate the exclusion of people without caregivers in clinical research [1, 4–6]. Finally, there is a risk of both response and confirmation bias. Interviewees may have censored themselves due to the audio-recording of interviews and may have focused on what they perceived the interviewer wanted to hear. Confirmation bias is possible given that the lead author was the single coder and drew upon relevant theories and literature for analysis. The lead author mitigated some of this bias by writing field notes during and after interviews, making a conscious effort to self-assess during analysis, and engaging the CAB and dissertation committee in member-checking and interpretation of findings.
Conclusions
This research study identified factors affecting dementia clinical research participation in the Portland, Oregon metropolitan area. The reasons why people with dementia and caregivers choose to participate in clinical research are complex, as participation requires both the ability and the willingness to participate. These interviews provided a unique opportunity for people with dementia and caregivers to describe their decisions to participate or not participate in a research study, especially from those who are not part of an existing research cohort. The themes described here offer insights into understanding some of the factors affecting how people with dementia and their caregivers make decisions to participate in clinical research (or not). Themes were similar across dyads that had previously participated in dementia research and dyads that had not, yet their decisions were different.
This study is supported by calls from academics, advocates, and the NIA to conduct more work on barriers, facilitators, and strategies for dementia clinical research participation and to include the voices of people with dementia and caregivers. The unique perspectives of the interviewees reinforce findings from the literature, but more importantly, capture their lived expertise and knowledge on the subject matter. When combined with a reframing of factors affecting dementia clinical research enrollment in the context of ability and willingness to participate, these findings may be useful for articulating factors and developing strategies to enhance participation in clinical research—and advance efforts dedicated to finding new effective treatments for dementia. Future studies can advance this work through the inclusion of non-English speaking participants and people with dementia without caregivers, people of color, and replication in diverse geographic areas.
Acknowledgements
The authors would like to thank the Bouranis Community Advisory Board, the study participants, and Dr. Bouranis’s dissertation committee advisors (Dawn Richardson, Elizabeth Needham Waddell, and Hyeyoung Woo) for their contributions to this article. This study was supported, in part, by Oregonians through the Alzheimer’s Disease Research Fund of the Oregon Charitable Checkoff Program.
Declarations
Funding
This study was supported, in part, by Oregon taxpayers through the Alzheimer’s Disease Research Fund of the Oregon Charitable Checkoff Program. This fund is administered by the Oregon Partnership for Alzheimer’s Research. (Grant #: 329193).
Conflicts of Interest
All authors declare they have no conflicts of interest.
Ethics Approval
Protocols were reviewed and approved by the Portland State University Institutional Review Board (IRB #184914). All participants provided written informed consent.
Consent to Participate
Informed consent was provided by all participants in this study.
Consent for Publication
Not applicable.
Data and code availability
The data that support the findings of this study are available on request from the corresponding author [NB]. The data are not publicly available as the contents could compromise research participant privacy.
Authorship contributions
Nicole Bouranis was the principal investigator of the study, wrote the initial drafts for this article, and incorporated all feedback and revisions. Sherril Gelmon provided mentorship to the principal investigator throughout the study as well as supervision, critical review, and commentary on the manuscript. Allison Lindauer provided mentorship to the principal investigator throughout the study as well as critical review and commentary on the manuscript.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data that support the findings of this study are available on request from the corresponding author [NB]. The data are not publicly available as the contents could compromise research participant privacy.