Barriers to Alzheimer Disease Clinical Trial Participation in a Minority Population

Abstract

Background:

Alzheimer disease (AD), the most common neurodegenerative disorder in the United States, disproportionately burdens minority populations.

Objective:

To explore barriers to AD clinical trial participation by Asian and Native Hawaiian patients diagnosed with AD or mild cognitive impairment.

Method:

We surveyed 187 patients with a Mini-Mental State Examination score ≥14 between January 2022 and June 2022. The score cutoff for clinical trial eligibility was set by the institution. Individuals also completed a 15-question telephone survey that assessed demographics, barriers to clinical trial participation, and clinical trial improvement methods.

Results:

Forty-nine patients responded, with a response rate of 26%. Asian and Native Hawaiian patients were less likely than White patients to participate in AD trials. The main barrier to participation was a lack of information about AD trials. Providing additional information regarding AD trials to patients and family members were listed as the top two reasons patients would consider participating in a clinical trial.

Conclusion:

Insufficient information about AD clinical trials is the primary barrier to participation among Asian and Native Hawaiian patients, followed by difficulty coordinating transportation and, in the case of Asians, the time required for clinical trials. Increased outreach, education, and assistance with logistics in these populations should be pursued to improve rates of participation in clinical trials.

Alzheimer disease (AD) is the most common neurodegenerative disorder in the United States, and it disproportionately burdens minority populations (Soria Lopez et al., 2019). Yet, AD clinical trials regularly face a shortage of eligible participants numbering in the thousands, and this number is set to increase in the next several years (Indorewalla et al., 2021; Institute of Medicine, 2012). More than one-fourth of all clinical trials in the United States fail to recruit even a single participant, and only one-third of multicenter trials achieve their planned enrollment goals. Often, this leads many trials to close prematurely, citing insufficient recruitment (Institute of Medicine, 2012; Vaswani et al., 2020; Walter et al., 2020).

The issue of recruitment has been linked to many barriers to clinical trial participation. These barriers unequally impact women and racial and ethnic minority populations despite these groups having higher rates of chronic illnesses (Calderón et al., 2006; Coakley et al., 2012; George et al., 2014; Gilmore-Bykovskyi et al., 2019; Gollin et al., 2005; Indorewalla et al., 2021; Kwiatkowski et al., 2013; Rivers et al., 2013; Swanson and Bailar, 2002; Walter et al., 2020).

Previous research into barriers to clinical trial participation found that economic, structural, and logistical obstacles negatively impacted recruitment efforts, with examples including financial burdens, time constraints, and transportation inconveniences (Bonk, 2010; Clark et al., 2019; Clement et al., 2019; Cox et al., 2019; Graham et al., 2017; Heller et al., 2014; Indorewalla et al., 2021; Jefferson et al., 2011; Largent et al., 2018; McDougall et al., 2015; Rios-Romenets et al., 2018; Vaswani et al., 2020; Young et al., 2015). A lack of participation from key groups within the US population affects the generalizability of trial results, effectiveness of therapeutic agents, and equity in the provision of health care (Coakley et al., 2012; George et al., 2014; Indorewalla et al., 2021; Kwiatkowski et al., 2013; Rivers et al., 2013; Swanson and Bailar, 2002).

In ethnic minority patients, additional factors such as a lack of trust in medical institutions or a scarcity of information about clinical trials were found to impact enrollment decisions (Calderón et al., 2006; George et al., 2014; Gollin et al., 2005). Even when individuals were interested in participating in clinical trials for altruistic or personal reasons, they referenced similar logistical, financial, and psychosocial barriers that dissuaded them from enrolling (Cox et al., 2019; Jefferson et al., 2011). Such barriers were often cited as including, but not limited to, opportunity costs in the form of lost wages, lack of financial compensation for their time, potential health risks, lack of adequate transportation, prolonged study durations, and lack of access to health insurance (Bonk, 2010; Clark et al., 2019; Clement et al., 2019; Cox et al., 2019; Graham et al., 2017; Heller et al., 2014; Indorewalla et al., 2021; Jefferson et al., 2011; Largent et al., 2018; McDougall et al., 2015; Rios-Romenets et al., 2018; Vaswani et al., 2020; Young et al., 2015). These impediments to clinical trial enrollment are especially important for diseases like AD, which has ethnicity-dependent pathophysiology, thereby indicating the importance of diversity in clinical trial participation (Howell et al., 2017; Morris et al., 2019).

Although previous research has assessed the primary reasons for a lack of AD clinical trial participation in minority groups, most of these studies investigated Black patients (Clark et al., 2019; George et al., 2014; Largent et al., 2018). Among minority populations, Asians and Native Hawaiians (NHs) are two of the least researched populations (George et al., 2014; Gilmore-Bykovskyi et al., 2019; Gollin et al., 2005; Indorewalla et al., 2021). As of 2021, people who identified as solely Asian or NH made up 36.8% and 10.5% of the Hawaii population, respectively, making them two of the largest racial groups in the state (U.S. Census Bureau, 2021).

We decided to explore the barriers to AD clinical trial participation in patients with a diagnosis of AD or mild cognitive impairment (MCI) in Hawaii, the state with the largest relative population of Asian and NH individuals in the United States.

METHOD

Participants

We conducted our study at the Hawaii Pacific Neuroscience Memory Disorders Center & Alzheimer’s Research Unit, an outpatient memory disorders center in Honolulu, Hawaii. Patients were referred to the center by hospitals and providers from across the state. The study inclusion criteria included patients who had been seen at the center from January 2022 to June 2022 who were ≥18 years of age, were diagnosed with either AD or MCI in the year 2022, and had a Mini-Mental State Examination (MMSE; Folstein et al., 1975) score of ≥14. The MMSE score cutoff for AD clinical trial eligibility was set by the center because it has been shown that MMSE scores between 11 and 20 are associated with moderate dementia, and most AD clinical trials do not recruit patients with severe dementia (Perneczky et al., 2006).

We contacted by telephone all of the patients who fit the inclusion criteria and briefed them on the details of the study. Once informed, patients were recruited to the study on a volunteer basis. For patients who could not comfortably respond to the telephone survey questions due to their illness, their primary caregiver was allowed to complete the survey on their behalf.

Patients had been diagnosed with AD or MCI by a team of board-certified neurologists either at the center where the study was conducted or at a community hospital before being referred to the center for follow-up outpatient care. Relevant patient characteristics such as age, sex, MMSE score, and diagnosis were recorded via a retrospective manual chart review. The remaining patient data were collected via a telephone survey We used this data collection modality because it has been shown to be fast and cost effective, increase participant understanding of questions, and produce higher response rates among study participants (Jones et al., 2013). Additionally, telephone surveys have been used in AD research for everything from collecting accurate patient responses to screening patients for AD-related cognitive disorders (Alexopoulos et al., 2021; Reckess et al., 2013).

The study was approved by the University of Hawaii Institutional Review Board and was classified as exempt research. Additionally, the study was performed according to the ethical guidelines of the Declaration of Helsinki and its later amendments. After being briefed on the study, and before being enrolled in it, all of the interested patients and/or caregivers provided informed consent over the phone.

Telephone Survey

We created a 15-question survey to be used over the telephone to gather detailed and current information from each patient and his or her caregiver that was unavailable in the patient’s electronic medical record. These questions asked about patient characteristics and the patient’s perspectives surrounding AD clinical trial participation. The survey gathered information regarding demographics (e.g., race, marital status, highest level of education, health care decision maker, and current or past participation in an AD clinical trial), personal perspective (i.e., reason to participate in a trial), barriers to clinical trial participation (e.g., lack of social support, psychosocial conflicts such as mistrust of the medical community, fear, lack of confidence in trial effectiveness, and stigma related to research participation; fear of side effects of trial medicine; lack of information about clinical trials such as the patient wanting more information about trial benefits and details; logistical complications such as distance, inability to secure transportation, lack of childcare, and scheduling conflicts; financial burden such as whether the cost of participating made up for the loss of payment from their job; time required, such as the difficulty of requiring multiple clinic visits; language barriers; and ineligibility to participate), and clinical trial improvement methods (e.g., additional information given to patients about the safety and usefulness of clinical trials; additional clinical trial hours on weekends and/or outside of work hours; complimentary transportation to and from clinic sites; increased financial compensation for trial participation; and language translators to help assist with the trials).

Statistical Analysis

We used descriptive statistics to summarize the patients’ characteristics: means (standard deviations) for continuous variables and frequencies (percentages) for categorical variables. Differences in patient responses were compared between patients who were currently participating in AD clinical trials and patients who were not currently participating as well as among racial groups. The analyses were performed using Wilcoxon rank-sum tests for continuous variables and Fisher’s exact tests for categorical variables.

P values were included to indicate significant differences in patient group responses. A two-tailed P value of <0.05 was considered statistically significant. All of the analyses were conducted in R version 4.0.2 (R Core Team, 2020).

RESULTS

Participants

The final population included 187 patients (134 AD and 53 MCI) eligible for participation. However, of the 187 eligible patients, only 49 (26%) chose to participate in the study (29 AD, 20 MCI). The mean age of the participants was 77 years, and the mean MMSE score was 23.2. Fifty-one percent of the patients were male, and 45% were White, followed by 37% Asian and 18% NH. Table 1 displays the demographic and survey data for the study.

TABLE 1.

Results of all Surveyed Patients With Alzheimer Disease or Mild Cognitive Impairment

Characteristic or Question	Overall N = 49 n/N %	Currently Participating N = 39 n/N %	Not Currently Participating N = 10 n/N %	P †
Age (years; M, SD)	77.1 (±8.6)	76.8 (±9.0)	78.6 (±7.3)	0.728
Female	24/49 (49)	21/39 (54)	3/10 (30)	0.289
Race				0.088
Asian	18/49 (37)	17/39 (44)	1/10 (10)
Native Hawaiian	9/49 (18)	7/39 (18)	2/10 (20)
White	22/49 (45)	15/39 (38)	7/10 (70)
MMSE score (M, SD)	23.2 (±3.2)	23.2 (±3.1)	23.0 (±3.7)	0.792
What is your (the responder's) relationship to Mr./Mrs. _______?				0.418
Friend	1/49 (2.0)	0/39 (0)	1/10 (10)
Husband, wife, or domestic partner	13/49 (27)	11/39 (28)	2/10 (20)
Other family member	4/49 (8)	4/39 (10)	0/10 (0)
Self	21/49 (43)	16/39 (41)	5/10 (50)
Son or daughter	10/49 (20)	8/39 (21)	2/10 (20)
Who is present for the survey?				0.721
Caregiver	17/49 (35)	13/39 (33)	4/10 (40)
Caregiver and patient	32/49 (65)	26/39 (67)	6/10 (60)
How well informed does the patient feel about Alzheimer’s disease clinical trials and their eligibility to participate?				0.236
Little to no knowledge	17/48 (35)	15/38 (39)	2/10 (20)
Some knowledge	24/48 (50)	19/38 (50)	5/10 (50)
Very knowledgeable	7/48 (15)	4/38 (11)	3/10 (30)
What was the patient’s reason for choosing to participate in a trial?
To help others	16/23 (70)	7/13 (54)	9/10 (90)	0.089
Doctor recommended	8/23 (35)	3/13 (23)	5/10 (50)	0.221
Potential to slow disease	20/23 (87)	11/13 (85)	9/10 (90)	1.000
Best option available	5/23 (22)	2/13 (15)	3/10 (30)	0.618
Was identifying a potential study partner a barrier to participation (a primary person that will ensure the patient will attend all their appointments and help them with their clinical trial participation)?	1/43 (2.3)	1/35 (2.9)	0/8 (0)	1.000
If unable to find a study partner, was the potential study partner their adult child?	0/1 (0)	0/1 (0)	0/0 (NA)
Was the potential study partner not able to assist due to being unable to get time off from work or due to a fear of losing income from time spent away from work?	0/1 (0)	0/1 (0)	0/0 (NA)
If the patient declined to participate or had issues participating in a clinical trial in the past, was it due to any of the following?
Low level of social support	2/26 (7.7)	2/24 (8.3)	0/2 (0)	1.000
Psychosocial conflicts	1/26 (3.8)	1/24 (4.2)	0/2 (0)	1.000
Fear of side effects of trial medicine	2/26 (7.7)	2/24 (8.3)	0/2 (0)	1.000
Lack of information about trials	12/26 (46)	12/24 (50)	0/2 (0)	0.483
Logistical complications	7/26 (27)	6/24 (25)	1/2 (50)	0.474
Financial burden	0/26 (0)	0/24 (0)	0/2 (0)
Time required	3/26 (12)	2/24 (8.3)	1/2 (50)	0.222
Language barriers	2/26 (7.7)	2/24 (8.3)	0/2 (0)	1.000
Ineligible to participate	3/26 (12)	3/24 (12)	0/2 (0)	1.000
Would the patient consider participating in a future clinical trial if any of the following were implemented?
Additional information given to family members to help them understand the benefits of participating in clinical trials	20/32 (62)	18/28 (64)	2/4 (50)	0.620
Additional information given to patients about the safety and usefulness of clinical trials	22/32 (69)	20/28 (71)	2/4 (50)	0.572
Additional clinical trial hours on weekends and/or outside of work hours	12/32 (38)	9/28 (32)	3/4 (75)	0.136
Complimentary transportation to and from clinic sites	11/32 (34)	9/28 (32)	2/4 (50)	0.593
Increased financial compensation for trial participation	13/32 (41)	11/28 (39)	2/4 (50)	1.000
Language translators to help assist with the trials	4/32 (12)	4/28 (14)	0/4 (0)	1.000
Who makes decisions with the patient in regard to their health care and treatments?				0.686
Immediate family	14/49 (29)	10/39 (26)	4/10 (40)
Patient and immediate family	20/49 (41)	17/39 (44)	3/10 (30)
Patient and primary caregiver	3/49 (6.1)	3/39 (7.7)	0/10 (0)
Patient only	12/49 (24)	9/39 (23)	3/10 (30)
What is the highest level of education the patient completed?				0.095
Associate or bachelors	20/48 (42)	19/38 (50)	1/10 (10)
Graduate	9/48 (19)	6/38 (16)	3/10 (30)
High school or GED	8/48 (17)	6/38 (16)	2/10 (20)
Some college	9/48 (19)	6/38 (16)	3/10 (30)
Some high school	2/48 (4.2)	1/38 (2.6)	1/10 (10)
What is the patient’s marital status?				0.568
Divorced or separated	5/49 (10)	3/39 (7.7)	2/10 (20)
Married or partnered	30/49 (61)	25/39 (64)	5/10 (50)
Single	7/49 (14)	6/39 (15)	1/10 (10)
Widowed	7/49 (14)	5/39 (13)	2/10 (20)
Patient diagnosis				0.167
Alzheimer's disease	29/49 (59)	21/39 (54)	8/10 (80)
Mild cognitive impairment	20/49 (41)	18/39 (46)	2/10 (20)

Some of the denominators may differ from the group size due to missing values (patient[s] decided to not answer the associated questions).

^†P values were based on Wilcoxon rank-sum tests for continuous variables and Fisher's exact tests for categorical variables.

Less than half (43%) of the patients answered the survey questions themselves, and both the patient and his or her caretaker were present during 65% of the surveys. Overall, 65% of the patients who responded felt that they either had some knowledge or were very knowledgeable about AD clinical trials, and health care decisions were typically made by both the patient and his or her immediate family (41%).

Survey results by race are displayed in Table 2. Of the patients surveyed, 5.6% of Asian, 22% of NH, and 32% of White patients were currently, or had previously been, enrolled in an AD clinical trial. Patient decisions to participate in an AD clinical trial varied little by race, with the exception of participating with the goal of helping others, which showed a significant difference based on racial group (P = 0.023). Other factors that influenced the patients’ decision to participate in an AD clinical trial included the potential to slow disease (87%), a doctor’s recommendation (35%), and the trial being the best option available (22%).

TABLE 2.

Barriers, Alzheimer Disease Trial Improvement Preferences, and Characteristics of Patients by Race

Characteristic or Question	Asian N = 18 n/N %	Native Hawaiian N = 9 n/N %	White N = 22 n/N %	P †
How well informed does the patient feel about Alzheimer’s disease clinical trials and their eligibility to participate?				0.138
Little to no knowledge	6/17 (35%)	6/9 (67%)	5/22 (23%)
Some knowledge	10/17 (59%)	2/9 (22%)	12/22 (55%)
Very knowledgeable	1/17 (5.9%)	1/9 (11%)	5/22 (23%)
Is the patient currently participating in or have they participated in an Alzheimer’s disease clinical trial before?	1/18 (5.6%)	2/9 (22%)	7/22 (32%)	0.088
What was the patient’s reason for choosing to participate in a trial?
To help others	2/7 (29%)	4/5 (80%)	10/11 (91%)	0.023*
Doctor recommended	3/7 (43%)	2/5 (40%)	3/11 (27%)	0.859
Potential to slow disease	5/7 (71%)	5/5 (100%)	10/11 (91%)	0.410
Best option available	1/7 (14%)	2/5 (40%)	2/11 (18%)	0.657
If the patient declined to participate or had issues participating in a clinical trial in the past, was it due to any of the following?
Low level of social support	1/10 (10%)	1/5 (20%)	0/11 (0%)	0.323
Psychosocial conflicts	0/10 (0%)	0/5 (0%)	1/11 (9.1%)	1.000
Fear of side effects of trial medicine	1/10 (10%)	0/5 (0%)	1/11 (9.1%)	1.000
Lack of information about trials	3/10 (30%)	4/5 (80%)	5/11 (45%)	0.204
Logistical complications	3/10 (30%)	1/5 (20%)	3/11 (27%)	1.000
Financial burden	0/10 (0%)	0/5 (0%)	0/11 (0%)
Time required	2/10 (20%)	0/5 (0%)	1/11 (9.1%)	0.577
Language barriers	2/10 (20%)	0/5 (0%)	0/11 (0%)	0.169
Ineligible to participate	2/10 (20%)	0/5 (0%)	1/11 (9.1%)	0.577
Would the patient consider participating in a future clinical trial if any of the following were implemented?
Additional information given to family members to help them understand the benefits of participating in clinical trials	7/11 (64%)	7/8 (88%)	6/13 (46%)	0.155
Additional information given to patients about the safety and usefulness of clinical trials	7/11 (64%)	7/8 (88%)	8/13 (62%)	0.502
Additional clinical trial hours on weekends and or outside of work hours	3/11 (27%)	4/8 (50%)	5/13 (38%)	0.525
Complimentary transportation to and from clinic sites	3/11 (27%)	2/8 (25%)	6/13 (46%)	0.578
Increased financial compensation for trial participation	4/11 (36%)	3/8 (38%)	6/13 (46%)	0.904
Language translators to help assist with the trials	3/11 (27%)	0/8 (0%)	1/13 (7.7%)	0.208
Who makes decisions with the patient in regard to their health care and treatments?				0.488
Immediate family	7/18 (39%)	2/9 (22%)	5/22 (23%)
Patient and immediate family	7/18 (39%)	6/9 (67%)	7/22 (32%)
Patient and primary caregiver	1/18 (5.6%)	0/9 (0%)	2/22 (9.1%)
Patient only	3/18 (17%)	1/9 (11%)	8/22 (36%)
What is the highest level of education the patient completed?				0.206
Associate or bachelors	8/17 (47%)	2/9 (22%)	10/22 (45%)
Graduate	3/17 (18%)	0/9 (0%)	6/22 (27%)
High school or GED	4/17 (24%)	2/9 (22%)	2/22 (9.1%)
Some college	2/17 (12%)	4/9 (44%)	3/22 (14%)
Some high school	0/17 (0%)	1/9 (11%)	1/22 (4.5%)
What is the patient’s marital status?				0.049*
Divorced or separated	0/18 (0%)	2/9 (22%)	3/22 (14%)
Married or partnered	12/18 (67%)	6/9 (67%)	12/22 (55%)
Single	1/18 (5.6%)	0/9 (0%)	6/22 (27%)
Widowed	5/18 (28%)	1/9 (11%)	1/22 (4.5%)

Some of the denominators may differ from the group size due to missing values (patient[s] decided to not answer the associated question).

^*Significant at P < 0.05.

^†P values were based on Fisher's exact tests.

The main reported barriers to participation were a lack of information about AD clinical trials (30% Asian, 80% NH, 45% White) and logistical complications (30% Asian, 20% NH, 27% White). Survey results among Asian and NH patients suggested that clinical AD trial recruitment would improve if information on the benefits of participating in clinical trials was provided to family members (64% Asian, 88% NH) and if information on the safety and usefulness of clinical trials was provided to patients (64% Asian, 88% NH). The third method to improve recruitment varied, with Asian patients preferring increased financial compensation (36%) and NH patients preferring expanded clinical hours (50%). White patients, however, listed additional information on the safety and usefulness of clinical trials as their top preferred change (62%), with secondary preferred changes being tied between providing additional trial information to family members, providing complimentary transportation, and increasing financial compensation (46%).

DISCUSSION

According to our study results, Asian and NH patients often feel that they lack information and they encounter logistical obstacles when it comes to AD clinical trial participation. Previous research on ways to increase minority clinical trial participation found similar results, listing a lack of information, lack of trial awareness, and time and resource constraints among the top five barriers to AD clinical trial participation (Clark et al., 2019). Interestingly, White patients shared similar barriers to participation, which highlights potential issues with how AD clinical trials are run across all three races.

Identifying barriers to AD clinical trial participation in NH patients is important because these patients have been understudied and may present with a number of unexplored factors that may contribute to AD compared to other races. Previous studies have shown that NH patients with AD have an earlier disease onset, a higher female prevalence, and more AD/MCI comorbidities than non-NH patients with AD (Smith et al., 2021). This lack of information is compounded in women who, as a whole, are disproportionately affected by late-stage AD and are underrepresented in AD clinical trials (Coakley et al., 2012; Kwiatkowski et al., 2013; Rivers et al., 2013; Scheyer et al., 2018; Swanson and Bailar, 2002). These unique characteristics could increase the barriers to AD clinical trial participation perceived by NH patients.

The top two AD trial recruitment improvement methods cited in our study were consistent across both the Asian and NH populations (i.e., additional information provided to family members and to patients). White patients similarly wanted additional information to be provided to family members and to patients but also wanted complimentary transportation and increased financial compensation.

Past studies that identified preferred incentives in aging AD clinical trial patients found complimentary transportation to be the most popular incentive overall, with financial compensation being especially important in minority populations (Bonk, 2010; Clark et al., 2019; Clement et al., 2019; Graham et al., 2018; Heller et al., 2014; McDougall et al., 2015; Young et al., 2015). Both of these conclusions were contrary to our findings, which could be attributed to the collectivist culture of many Hawaiian residents and the smaller geographic size of Hawaii (Pokhrel et al., 2016).

Compared to other states, Hawaii has a large prevalence of Japanese and Chinese culture centered around the idea of ohana (family). Similarly, NHs place a high level of importance on the family unit, which is reflected in their daily lives (Andrade and Bell, 2011; Pokhrel et al., 2016). Family is a driving influence for the social, cultural, and political ideologies held by NHs (Pokhrel et al., 2016). This belief system stems from the 20th century, when outsiders migrated to Hawaii and NHs relied on each other for support.

This type of collectivist culture creates a strong support system, extending the traditional nuclear family to include makua (aunts and uncles) and kupuna (grandparents). A strong social network is crucial for optimal patient outcomes and has widespread empirical support. The creation of community-based health programs has also been shown to improve health care management and patient understanding of disease in NH populations (Higa et al., 2021). Combining the benefit of community programs with the strong support system inherent to NH families could help to bridge the information gap between patients, their families, and clinical trials.

Similar to the NH patients in our study, the Asian patients in our study wanted additional information to be provided to family members and to patients. Because collectivist ideologies are also emphasized in Asian culture, many health care decisions are made as a family rather than as an individual (McLaughlin and Braun, 1998). This cultural difference helps to clarify the results seen in our study compared with White participants and past literature. Two such studies documented barriers to clinical trial participation among Asians in Singapore and Britain (Hussain-Gambles, 2004; Lee et al., 2016). The results of these studies determined that barriers and facilitators to clinical trial participation in Asians were similar to those of White trial participants. This finding could be attributed to the difference in Asian culture in other countries compared to the United States, where the value of the family unit is held strongly in Asians, similar to what was seen in NHs (Pokhrel et al., 2016). Knowing this, providing Asian patients and their families with more detailed clinical trial information and allowing them sufficient time to discuss it as a family should be made a priority. Having this additional knowledge and support may help Asians make future clinical trial enrollment decisions more confidently.

Logistical obstacles in the form of distance from AD clinical trial sites, inability to secure transportation, and scheduling conflicts also prevented patients from participating in clinical trials. While this was not the primary obstacle to participation in AD trials, patients still noted transportation as a significant obstacle to trial enrollment. The disparity between mokus (regions) in Hawaii could have contributed to this issue (Winter et al., 2018). Oahu is split into six major mokus, and access to health care and transit services varies considerably between them. Patients living in Honolulu may benefit from transportation services that patients living in Kahuku, a rural city in northeast Oahu, do not have access to.

Transportation was found to be a barrier to clinical trial participation in past studies, and while it was a concern for our study’s participants, it was not their primary obstacle. This finding could be attributed to access to affordable paratransit services in Hawaii (Ing et al., 2014). Additionally, having a strong support system allows for more transportation options, including private transportation or better scheduling of government transportation services, leading to this being less of a concern in Asian and NH patients than additional information regarding AD clinical trials.

Health care access to rural parts of Hawaii is an ongoing issue that still has not been adequately addressed. Although it may not have affected the majority of our study participants, examining disparities in barriers to clinical trial participation by moku could provide a more nuanced look at Hawaii-specific barriers.

Study Limitations

Our pilot study was strengthened by its inclusion of racial minorities who are not often represented in literature on clinical trial participation and whose unique health risks are often not considered by researchers. However, our study was limited by its response rate. We used a 6-month time period, which we felt was adequate for a robust participation rate. However, we only experienced a response rate of 26.2%. Although limited, these results provide useful insight, and future research should look into a larger cohort spanning a wider range of time in order to better generalize the results and provide a more complete dataset.

An additional limitation was the incomplete reporting of surveys by study participants. The majority of the surveys were incomplete, yielding valid but limited results. This inconsistency in the number of responses per question led to variability within the results. Follow-up can be performed to resolve incomplete data and incentives implemented to increase the number of complete survey responses.

CONCLUSION

Insufficient information about AD clinical trials is the primary barrier to participation among Asian and NH patients, followed by difficulty with coordinating transportation and finding time to participate in AD trials. Increased outreach, education, and assistance with trial logistics in these populations should be pursued to improve the rates of clinic trial participation by Asian and NH patients with AD or MCI.

Glossary

AD

Alzheimer disease

MCI

mild cognitive impairment

MMSE

Mini-Mental State Examination

NH

Native Hawaiian