Insights from recruiting individuals with mild dementia and care partners for a multi-site oral hygiene intervention

Abstract

Background:

Maintaining oral health is essential for individuals with dementia, yet they often need support. We sought to identify insights gained during the recruitment process for an intervention designed to teach care partners skills to guide individuals with mild dementia in proper oral hygiene techniques and provide reminders to practice oral hygiene care.

Methods:

Throughout the study, research team members from two research sites met regularly to discuss their experiences in recruiting participants. Notes from these meetings served as the basis for identifying key challenges and effective strategies.

Results:

Recruitment involved direct patient engagement, collaboration with dementia research centers and community organizations, and the use of electronic health record systems, including MyChart. Recruitment coordinators connected study personnel with organizations and support groups, thereby broadening the recruitment base. Barriers to recruitment included the reduced frequency of patient visits to clinics during the COVID-19 pandemic, which limited in-person recruitment opportunities, as well as the time required to establish new relationships with non-affiliated hospitals and community organizations. Recruitment efforts successfully integrated long-standing relationships with dementia research centers and healthcare providers alongside the establishment of new partnerships with community organizations and non-affiliated hospitals.

Conclusion:

Flexibility, participant-centered communication, and a multifaceted approach were critical for overcoming pandemic-related challenges and addressing recruitment barriers, ensuring diverse and well-retained participation in this study.

1. Introduction

With dementia becoming a pressing global issue, there is increasing recognition of the need for interventions that address not only cognitive decline but also the broader health challenges faced by individuals with dementia, including oral health [1]. Oral hygiene, which refers to the practice of maintaining clean teeth and gums, is one of the most effective ways to promote and sustain optimal oral health [2]. Among individuals with mild dementia, maintaining good oral hygiene is particularly crucial, as it is closely tied to their overall well-being, nutrition, and quality of life [3] Compared to individuals without cognitive impairment, those with mild dementia are at higher risk for poor oral health outcomes, including periodontal disease, tooth loss, and complications such as difficulty in chewing and swallowing, which can lead to inadequate nutrition and even systemic health issues like respiratory infections and cardiovascular disease [4–6]. Furthermore, emerging evidence suggests that improving oral health and oral hygiene may have cognitive benefits [5,7,8].

Recognizing these needs, we developed an intervention to train care partners in supporting oral hygiene for individuals with mild dementia. This includes skills like brushing, flossing, and denture care, along with strategies for providing reminders and practical support [9]. Evidence suggests that involving care partners in interventions can lead to improved oral health outcomes and enhanced quality of life for individuals with dementia [10–12]. Our intervention is designed to support this involvement, focusing on equipping care partners with the necessary skills to assist individuals with dementia in maintaining proper oral hygiene and having a higher overall quality of life.

Despite the clear benefits, recruiting and retaining persons with dementia and their care partners for research interventions remains challenging. Stigma surrounding dementia, privacy concerns, and fear of social judgment can deter families from participating [13]. Additionally, care partners often face emotional strain, and the perceived complexity and burden of the intervention itself can hinder recruitment efforts [14,15]. Nonetheless, previous research has shown that certain strategies, such as providing logistical support and having timely communication can enhance both recruitment and retention [15]. While these strategies have proven effective, their success can be limited when interventions are perceived as overly demanding or when participant needs are inadequately addressed [14,16].

Our study makes a unique contribution to the existing body of knowledge by identifying and evaluating effective recruitment strategies for recruiting participants and their care partners in non-pharmacological, oral health interventions for persons with mild dementia. There is a notable gap in the literature regarding recruitment strategies specifically for community-dwelling individuals with mild dementia and their care partners in oral hygiene interventions. Our study addresses this gap by examining recruitment challenges and highlighting the approaches we employed. These insights are critical for informing future research in developing and adapting recruitment strategies, ensuring greater inclusivity in dementia care research.

2. Methods

2.1. Description of the intervention

The overview of the intervention and eligibility criteria are provided below. For additional details, please refer to the protocol description found in Wu et al. [9]. This multi-site study was a three-arm randomized controlled trial. The primary objective was to improve oral hygiene outcomes by promoting positive oral hygiene behaviors and skills among individuals with mild dementia. Participants were randomly assigned to either Treatment Group 1, Treatment Group 2, or the Control Group. All participants (including the control group) received an educational booklet. Only participants in Treatment Groups 1 and 2 received smart toothbrushes. Treatment Group 2 also received tailored instruction on oral hygiene technique and the care partners and participants in this group received coaching to support behavior change. Oral health outcomes were compared across the three groups. The duration of the active intervention was 3 months, with an additional 3-month maintenance phase. Data collection involved three home visits: baseline, 3-month, and 6-month.

2.2. Eligibility criteria

Both participants with mild dementia and their care partners were recruited. Participants were included if they were (a) age 60 or above; (b) had a diagnosis of mild dementia within the past year; (c) had at least 4 teeth; (d) lived with an informal, unpaid, care partner who was willing to participate; (e) were community dwelling; and (f) were physically able to brush their own teeth. Participants were excluded if they (a) were unable to have an oral health evaluation done; (b) had sensory or physical problems that prevented participation in the intervention; (c) had a terminal illness or behavioral or psychiatric disorder that would interfere with participation in the intervention; (d) were at increased risk of bleeding due to a bleeding disorder such as having hemophilia or were prescribed antiplatelet or anticoagulant medications; (e) were prescribed antibiotics to be taken prior to a regular dental visit; (f) had a medical condition (e.g., serious congenital heart conditions, previous infective endocarditis, prosthetic cardiac valves, and cardiac transplantation) that placed them at greater risk of infection from the manipulation of the gums to measure the gingival index; (g) had a medical condition that suppresses the immune system; or (h) have had a total joint replacement with a history of an infection in the replaced joint.

2.3. Data sources

The data sources for this analysis were derived from regular weekly/biweekly meetings held among research team members (MPIs and research coordinators) from both sites (NYU and Duke), during which they discussed their progress with recruitment. These meetings provided valuable insights, with notes serving as a foundational resource for identifying key challenges and effective strategies in the recruitment process. Additionally, reflections from research coordinators, interventionists, and dental hygienists were documented through debriefing session minutes, progress reports, and qualitative data recorded in field notes and meeting minutes. Collectively, these diverse data sources informed the analysis, ensuring a comprehensive understanding of the recruitment dynamics.

2.4. Recruitment process

Participants were primarily recruited through the NYU Alzheimer’s Disease Research Center (NYU ADRC) and the Duke Memory Disorders Clinic. At the NYU ADRC, a recruitment coordinator reviewed upcoming patient appointments to identify potential participants. At the clinic visit or shortly after, the patient’s physician, clinical staff or the recruitment coordinator explained the study to the patient either in person or over the phone. If the patient expressed an interest in participating in the study, the recruitment coordinator forwarded their contact information to the study coordinator who would conduct a telephone screening to assess eligibility. Similar procedures were followed by a collaborating group to recruit participants from the Montefiore Center for Excellence for Alzheimer’s Disease (CEAD). These collaborators also connected study staff to various organizations working with various diverse populations throughout New York City. The study coordinator and recruitment staff then did in-person and virtual presentations with the staff of the organizations and potential participants. These organizations also included study recruitment materials in their newsletters and email blasts to advertise the study.

At Duke, in collaboration with providers at the Memory Disorders Clinic, potential participants were identified through electronic medical records. Potential participants were sent a letter describing the study and stating that a study coordinator would contact them to explain more about the study and to inquire of their interest Interested individuals were then screened by the study coordinator by telephone to assess eligibility.

2.5. Data analysis and rigor

We extracted and organized all relevant information from the data sources related to recruitment into a matrix. This matrix provided a structured framework, allowing us to categorize the data into key areas such as experiences, barriers, challenges, and strategies. The matrix was organized by source type (e.g., meeting notes, coordinator feedback, and investigator reflections), content domain (e.g., recruitment experiences, perceived barriers, retention challenges, and strategies), and assessment category (e.g., perceived effectiveness, feasibility, and suggested improvements). This structure allowed us to systematically capture and compare input across diverse contributors and sites. The matrix provided a foundation for thematic synthesis and guided an iterative process of identifying patterns and distinctions in recruitment experiences. This collaborative approach ensured that our analysis was firmly grounded in the data and accurately reflected the experiences and challenges encountered during recruitment.

3. Results

3.1. Participants recruited and retained

Enrollment took place between October 2021 through September 2023. Participants were enrolled in a staggered manner over the course of the study period. A total of 100 participants were screened. Sixty-seven were eligible. Sixty were enrolled with 23 participants enrolled at NYU and 37 participants enrolled at Duke. The original study goal was to enroll 120 participants which was not met by the end of the data collection period. There were 20 participants in each group (Treatment Group 1, Treatment Group 2, and Control Group). The attrition rate was 10 %, therefore approximately 90 % of participants and their care partners were retained. The enrolled participants were 45 % Female and 55 % Male. The racial breakdown was 78.33 % White, 18.33 % Black, and 3.33 % Multiracial or Other. The ethnicity distribution was 6.67 % Hispanic or Latino and 93.33 % not Hispanic or Latino.

3.2. Recruitment challenges

The recruitment process highlighted several challenges that influenced the ability to enroll enough participants.

3.2.1. Impact of the COVID-19 pandemic

Recruitment for the study was delayed due to COVID-19, which resulted in a shorter enrollment period than originally planned. In addition to the delay in recruitment, the COVID-19 pandemic significantly impacted the recruitment process. Reduced patient visits to clinics and concerns about virus transmission made it difficult to engage potential participants and complicated recruitment efforts.

3.2.2. Building relationships for recruitment

The two study sites had different levels of experience recruiting participants with dementia and their families from the community. The Duke University site has a longstanding outreach program which has focused on building relationships with numerous academic and community groups, including those often under-represented in research. In addition, this site has had long term collaborations with providers in the Memory Disorders Clinic and the Alzheimer’s Disease Research Center. The NYU site was just developing these types of relationships during this intervention. Thus, establishing trust with potential participants referred from non-affiliated hospitals and new sites presented a significant challenge. Patients referred by external sources, such as support groups or dementia organizations, were occasionally skeptical of the study’s legitimacy. To address the skepticism, our team implemented several strategies to validate the study and build trust. We prioritized transparent communication and relationship-building. This included providing clear, accessible study materials outlining our research goals, methods, and ethical safeguards. Additionally, our team partnered with trusted community organizations and made a concerted effort to establish rapport during initial interactions, emphasizing our track record and institutional affiliations.

3.3. Effective recruitment strategies

In response to the challenges faced during recruitment, several strategies were implemented successfully. One of the most critical aspects of successful recruitment was leveraging long-standing collaborations and established connections with healthcare providers and other key stakeholders. These pre-existing relationships were helpful in building trust with participants and facilitating smoother recruitment processes. At the same time, nurturing new relationships at additional sites was equally important. Developing new partnerships expanded our recruitment reach and allowed for diversity among participants. By fostering these collaborations, both old and new, we created a robust and supportive network that significantly improved recruitment efforts.

3.3.1. Collaboration with healthcare professionals

Establishing relationships with healthcare professionals who were in direct contact with patients was particularly effective. These professionals played a crucial role in identifying and referring eligible participants. This is best done with medical centers affiliated with the researchers’ universities or local hospitals. Researchers can meet with clinicians, who plan on referring patients, before the start of enrollment to discuss the study, barriers in recruitment, and provide study recruitment materials to facilitate recruitment.

3.3.2. Flexible scheduling

Providing flexible scheduling options for study visits was essential in accommodating participants’ needs, especially during the pandemic. This approach made it easier for participants to take part in the study, even under challenging circumstances. This can involve including appointment times outside the typical workday, such as early morning, evening, and weekend hours.

3.3.3. Clear and detailed communication

Clear and detailed communication with participants and their care partners was vital. By addressing any questions, doubts, or fears related to participation, the study team was able to build trust and ensure participant engagement. Providing details to the care partners about their involvement early on improved retention, as they were better prepared for their role in the intervention.

3.3.4. Direct engagement with potential participants and partnerships

Presentations at support groups and other relevant organizations allowed us to share information about the study directly with potential participants. Establishing partnerships with dementia research centers who can incorporate study recruitment with the center’s outreach program was found to be useful. These activities helped establish connections with potential participants and provided a platform for addressing concerns.

3.4. Suggested strategies for future studies

Based on the challenges encountered and the success of certain strategies, the study team suggests several approaches for future studies to enhance recruitment and retention.

3.4.1. Unforeseen impact of inclusion criteria

In any clinical trial, inclusion criteria are designed to ensure participant safety. However, one cannot predict that the safety profile and prescribing practices for a certain class of medications may change over the course of a trial. The use of anticoagulant or antiplatelet medications was an exclusion criterion in this study due to a small but potential risk of bleeding during the oral health evaluation. As such, individuals taking these medications at the time of screening were deemed ineligible and were not enrolled in the study. No participants began taking these medications after enrollment; therefore, this exclusion criterion did not impact participant retention. However, during the time between protocol development and recruitment, the prescription rates for these medication classes increased, and the safety profiles of newer agents improved. These changes could not have been anticipated at the outset of the study but had a substantial impact on eligibility rates. This experience underscores how evolving medical practices can influence participant eligibility and should be considered when designing future clinical trials.

3.4.2. Strengthen partnerships with organizations

Building and maintaining strong partnerships within your own institution, and with support groups, external organizations and non-affiliated hospitals, can enhance recruitment efforts. Emphasis should be on developing long term relationships with organizations and institutions. Such relationships should benefit both parties, meaning that the clientele the organization serves will benefit from participating in research and the research will benefit from the organization’s assistance with recruitment.

To effectively leverage these partnerships, researchers should identify and engage with relevant local organizations early in the planning stages, well before enrollment begins. This can involve reaching out to key contacts within these organizations to understand their interests and potential alignment with the study’s goals. Regular communication is critical throughout the recruitment process, including providing clear details about the study’s objectives, participant expectations, and how the organization’s involvement will benefit its members. Researchers can organize informational sessions or workshops with these partners to explain the study, address any concerns, and build trust. By fostering a collaborative relationship and ensuring that external partners feel involved and valued, researchers can encourage participation from a more diverse and engaged pool of potential participants.

3.4.3. Adapt to post-pandemic shift in research

The COVID-19 pandemic has led to a rapid shift to virtual health care and research. Many behavioral medicine research studies adapted to remote study procedures during the pandemic and many of these practices are now becoming permanent. Behavioral researchers should consider where they can implement remote research methods to facilitate recruitment and the intervention process.^[17]

3.5. Retention strategies

Throughout the six-month trial, study coordinators were available to respond to questions from participants and their care partners, ensuring consistent support during study visits and promptly addressing any questions or concerns. The intervention itself was designed with features tailored to care partners, such as promoting effective caregiving behaviors and incorporating strategies to support emotional coping. These components likely played a critical role in sustaining participants’ involvement and minimizing dropout, reaching a high retention rate of 90 %. This retention rate underscores the study’s success in regard to feasibility and engaging participants.

4. Discussion

Recruitment and retention of persons with dementia and their care partners are inherently challenging due to the unique needs and vulnerabilities of this population. In this study, we met the enrollment goal for racial and ethnic diversity, but we encountered challenges meeting the total enrollment goal for the study. The eligibility criteria, particularly the exclusion of participants on anticoagulants, were intended to ensure participant safety but inadvertently excluded a significant number of potential participants. This finding aligns with existing literature that highlights the difficulties in balancing safety with inclusivity in research involving older adults and vulnerable populations [18].

The success of recruitment efforts in Alzheimer’s research hinges on leveraging both long-standing partnerships with trusted healthcare providers and community partners, as well as establishing relationships with new entities. Trusted partnerships foster credibility and ensure access to networks with a history of supporting dementia-related research, as demonstrated by initiatives like the Alzheimer’s Disease Prevention Registry (ADPR) at Duke University, which successfully enrolled 26 % African American participants in a research registry of over 4677 individuals [19]. The success as recruitment sources of both the ADPR and its successor, the North Carolina Registry for Brain Health highlight the role of community partnerships in building and maintaining research registries as a prime recruitment source, the importance of dedicated and trained staff in developing local community partnerships, and the need for sustainable funding sources for targeted recruitment of diverse populations [20].

In addition, establishing new partnerships is crucial for enhancing recruitment efforts in Alzheimer’s research. The National Institute on Aging (NIA) emphasizes the importance of engaging diverse community partnerships to improve recruitment and retention in clinical trials [21]. Their strategy includes collaborating with local organizations and stakeholders to build trust and facilitate participation among under-represented populations. The Alzheimer’s Clinical Trials Consortium (ACTC) focuses on recruitment by establishing a minority outreach and recruitment team. This team employs evidence-based strategies to support both central and local partnerships with diverse communities, aiming to enhance recruitment and retention in Alzheimer’s disease clinical studies [22]. By balancing the use of well-established relationships with proactive cultivation of new partnerships, recruitment efforts can achieve greater inclusivity and diversity in Alzheimer’s research, offering a replicable model for future studies.

The onset of the COVID-19 pandemic introduced additional complexities, as reduced patient visits and heightened concerns about virus transmission made it challenging to engage potential participants. This experience is consistent with reports from other studies conducted during the pandemic, where recruitment efforts were similarly hindered by reduced in-person interactions and increased participant hesitancy [23]. However, our study also highlights the importance of adaptability, such as the implementation of flexible scheduling and stringent safety measures helped mitigate these challenges.

Despite these challenges, we implemented several strategies to improve recruitment and retention. successfully. Collaboration with healthcare professionals who were directly involved in patient care was particularly effective in identifying and referring eligible participants. This approach is supported by existing studies that highlight the value of clinician involvement in the recruitment process [24]. Our findings further emphasize that leveraging established relationships within the healthcare system can significantly enhance recruitment efforts.

Flexible scheduling options and clear, detailed communication with participants and their care partners were also crucial in building trust and ensuring participant engagement. These strategies align with the broader literature, which advocates for participant-centered approaches that accommodate individual needs and preferences [25,26]. The success of direct engagement through presentations and partnerships with dementia-focused organizations demonstrates the value of community involvement in the recruitment process, a theme that is increasingly recognized in the literature on dementia research.

The use of electronic health record (EHR) systems, such as MyChart, facilitated recruitment, helping staff identify potential participants. This approach is consistent with recent trends in clinical research, where digital tools are being used to enhance participant engagement [27]. Our findings suggest that EHR systems can play a crucial role in supporting recruitment, particularly when in-person interactions are limited.

5. Conclusion

In conclusion, our study highlights the critical role of building trust with participants and maintaining clear, flexible communication as foundational elements for successful recruitment and retention in dementia research. Nurturing established partnerships while forming new connections with additional sites is essential for broadening engagement and fostering inclusivity. Furthermore, future research should reevaluate certain precautionary measures to identify opportunities for modifications that streamline processes without compromising safety. Enhancing these aspects can improve the participant experience while still upholding the study’s integrity. By employing a multifaceted approach that emphasizes trust, communication, and adaptability, future studies can more effectively address recruitment and retention challenges, ensuring diverse and representative participation in non-pharmacological dementia interventions.