Using Community Engagement Methods to Guide Study Protocol Decisions for School-Aged Children With Type 1 Diabetes

These methods were used in preparation for a longitudinal study to understand the risk and protective factors for neurocognitive complications of type 1 diabetes. The longitudinal study protocol is expected to include cognitive testing and MRI studies of the brain in children aged 6–11 years, along with parent questionnaires and review of glucose data. In addition, we anticipate collecting real-time information using ecological momentary assessment (EMA) via a smartphone app to measure children’s outcomes, including sleep quality, physical activity, diet, mood, and behavior.

To identify potential problems with feasibility, we developed a survey for parents/caregivers to understand which aspects of the potential study protocol would make families more or less willing to participate. The feasibility survey consisted of 33 items, including questions about basic demographic information (child age, sex, race/ethnicity, and diabetes duration; parental education; and family income) and parent attitudes about compensation, scheduling, study-related blood work, receipt of information about the child’s MRI and cognitive testing results, and overall likelihood of study participation (Supplementary Material).

Families were eligible to participate in the feasibility survey if they had a child aged 6–11 years who had type 1 diabetes and was followed by the Vanderbilt Pediatric Diabetes Program. After obtaining informed e-consent, questions were asked over the phone (by a member of the research team and entered into a REDCap [Research Electronic Data Capture] database) or in person after a clinic appointment (completed by the parent on a digital tablet and entered directly into REDCap). On average, the survey took 5–10 minutes to complete, and parents received a $10 gift card upon completion of the survey.

We also conducted a CE Studio with caregivers of children with type 1 diabetes to obtain diverse perspectives on barriers to and facilitators of participation. Specifically, we sought their input for study outcomes and recruitment and retention strategies. The Studio was conducted by the Community Engaged Research Core, which is part of the Vanderbilt Institute for Clinical and Translational Research. The Studio was implemented by a team that included faculty researchers, a community navigator, and a skilled facilitator.

The CE Studio is an approved model for the NIH All of Us project. In this model, the Studio facilitator creates a neutral environment that allows for open and frank discussion and guides the conversation between the researchers and community experts (i.e., caregivers for children with type 1 diabetes). The Studio facilitator has experience working with diverse populations and possesses the ability to balance the power differential that may naturally occur when researchers and community members come together (9).

Before the Studio, the community navigator conducted a planning meeting with the research team. The CE Studio team invited individuals from a database of past community engagement experts, in addition to reaching out to community-based organizations working with children with type 1 diabetes and social media groups for parents/caregivers of children with type 1 diabetes. All interested caregivers completed an online form, which collected basic information, including demographics, educational background, and life experience (e.g., age of the child and diabetes duration).

The CE Studio team then selected a group to invite to the Studio to ensure a diverse representation of experiences. The community experts attended an orientation meeting before the Studio, during which they reviewed an orientation guide. The orientation guide included frequently asked questions and a glossary of common research terms. The guide also outlined the purpose of the CE Studio, the roles and expectations of participants, and the CE Studio process.

The navigator scheduled the Studio at a time that was convenient for most people. At the start of the CE Studio, the researchers (L.C.J. and S.S.J.) gave a brief presentation about the project and posed specific questions to the community experts. The facilitator guided the discussion and kept the meeting length to 1.5 hours. The navigator captured feedback by taking notes. The feedback included major themes from the discussion, as well as suggestions from individual community experts. Community experts were compensated $50 for their time. Because the CE Studio has a nonresearch designation by institutional review boards (IRBs), informed consent was not needed (9).

A total of 21 parents completed the survey over 4 months; 30% reported an annual family income <$50,000, and the median parental level of education was a college degree. The average child age was 8.7 ± 1.7 years, 90% of participants identified as non-Hispanic White, 10% identified as Black or African American, and 57% were male. Of the 34 families approached by phone, only five completed the feasibility survey (15%), but 16 of the 20 families approached in person completed the survey (80%). Missing data were minimal; one parent did not answer the question about family income.

The majority of parents (57%) preferred a gift card as compensation, 14% preferred a check, and 29% preferred a check plus a small gift for the child. The majority of parents (86%) found $40–50 to be a reasonable compensation for the MRI portion of the study, which takes ∼60 minutes, and 90% supported $50 as reasonable compensation for the cognitive testing, which takes ∼90 minutes. Most parents indicated that travel reimbursement was either somewhat important (43%) or very important (43%). Scheduling study visits and clinic visits on the same day was very important to most parents (67%), as well as having weekend and evening scheduling options available (67%).

Overall, 69% of parents indicated that they would participate in a study like this. Most parents (62%) said needing a blood draw from their child would not make a difference in their decision to participate, but 76% supported having numbing cream available for their child during the blood draw. If a child were to object to having blood drawn, 90% of parents indicated that they would allow the laboratory to draw extra blood (about two extra tubes) at the time of their child’s next routine blood testing for diabetes care.

When asked if they could think of a child the same age who might be interested in participating in a study as a control participant (i.e., a neighborhood control subject without diabetes), parents either said no (38%) or that they were not sure (38%). In addition, 38% of parents reported that having a friend participate along with their child would not make their child more or less likely to participate.

The majority of parents (67%) indicated that they would prefer to receive information on their child’s cognitive testing portion of the study. Parents deemed that provision of this information would be somewhat important (43%) or very important (43%) in their decision to participate. Most parents (76%) agreed that receiving a picture of their child’s brain after the MRI would make their child more interested in participating.

The CE Studio hosted a diverse sample of caregivers (n = 7), termed “community experts,” of whom four identified as African American or Black, two as White, and one as other race. All of the caregivers were aged 30–55 years; one had a child <5 years of age, three had children aged 5–12 years, and three had children ≥12 years of age. In terms of diabetes duration, three children were diagnosed <3 years before the Studio, 1 had been diagnosed 3–5 years before the Studio, and two had been diagnosed ≥5 years before the Studio. Community expert feedback from the session is presented in Table 1.

In the discussion around the timing of recruitment and enrollment, a two-part consent method was preferred for enrolling families with newly diagnosed children. Given concerns around the stressful nature of the diagnosis, community experts recommended that consent be obtained at the time of diagnosis for an initial blood draw and baseline data collection from the medical record only. Then, several weeks later, but within 3–6 months after diagnosis, these families could be approached to consent for participation in the full, longitudinal study protocol, including an MRI of the brain and cognitive assessments with the child, as well as parent surveys and EMA at multiple time points.

Community experts expressed a preference for pairing study visits with diabetes clinic visits to minimize burden. They also recommended offering travel-related compensation and childcare, when possible. As a strategy to enhance retention in the longitudinal study, community experts expressed interest in receiving retention items with the study logo (e.g., water bottles and small toys).

When asked about recruitment approaches, community experts noted the need for clear communication about the study protocol. For example, they wanted an explanation of the research being conducted in pediatric type 1 diabetes focused on cognition and risk and protective factors. Given concerns about children’s comfort level with the MRI machine, community experts suggested that a curated playlist of videos related to MRI sounds and procedures could be offered to comfort the child before participation. Community experts also requested feedback on their child’s cognitive testing results after study participation. They also expressed interest in receiving study updates and reminders via emailed newsletters, videos, and text messages.

The current study describes methods to engage community members in protocol decisions to enhance study feasibility. Caregivers for children with type 1 diabetes identified strategies to optimize recruitment and retention, especially among underrepresented populations. The feasibility survey was helpful in determining which aspects of the study design potential participants considered important when deciding whether to consent to study participation. The CE Studio offered more detailed suggestions for the recruitment and enrollment process. Findings from both the feasibility survey and the CE Studio indicated that most families were willing to participate in a study design that offered fair compensation, flexible scheduling, and a summary of their child’s cognitive functioning. Uniquely, the CE Studio allowed for dialogue and rich details that the feasibility survey could not capture.

Findings from both the feasibility survey and the CE Studio indicated high levels of support for a research study of this nature. Community experts expressed interest in learning about risk and protective factors for cognitive function in youth with type 1 diabetes but noted that participating in a research study at the time of diagnosis could be challenging, given that it is a time of high stress and confusion for caregivers. The community experts advised that deciding to enroll in a longitudinal research study at the time of diagnosis would be overwhelming; however, they supported a two-step consent plan to facilitate participation.

Findings from both the feasibility survey and the CE Studio supported aligning study visits with clinic visits, and community experts offered additional suggestions to make scheduling study visits more convenient, such as travel accommodations and meal vouchers, in line with strategies found to be successful in recruiting and retaining parents of newly diagnosed children (10). In general, the community experts provided context and solutions to potential barriers to study participation (Table 1).

The efficiency of the CE Studio model and the group dialogue with community experts were strengths of this approach. However, it is important to note that most of the caregivers who completed the feasibility survey and took part in the Studio had a child diagnosed with diabetes for >3 years and were answering based on their recollection of their mindset after their child’s diagnosis. In addition, the majority of the caregivers who completed the feasibility survey identified as non-Hispanic White, and these findings may not be generalizable to other populations. Finally, we did not have information on sociodemographic characteristics for families who were invited to complete the survey or take part in the Studio, so we cannot determine the representativeness of our sample.

We found the CE Studio process to be a helpful and efficient mechanism to obtain caregiver input during the study planning and design phase. Based on discussions with the community experts, we developed a study protocol that incorporated their concerns and suggestions around recruitment, scheduling, and receipt of study-related information. We believe their recommendations will translate into better study recruitment and retention and wanted to share this mechanism with other research teams. Before enrolling participants for a longitudinal cohort study, we plan to conduct an additional CE Studio at each study site and to invite community experts to be paid members of the research team (i.e., consultants).

The CE Studio approach is a consultative model (4,8) used to engage people with lived experience to inform aspects of study selection, design, conduct, or dissemination; it is typically exempt from IRB approval and provides rich information in a relatively short amount of time (9). Feasibility surveys offer information from a larger pool of potential participants but require IRB approval and substantial time by the research team for recruitment and enrollment (e.g., reviewing clinic schedules and meeting families in clinic before or after their diabetes visit). The alignment of themes and recommendations from these two approaches supports the potential benefit of the CE Studio as an efficient model for obtaining valuable information from community members when planning a study.

This study was sponsored by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (U34 DK123895-01).

No potential conflicts of interest relevant to this article were reported.

F.A. collected data and wrote the manuscript. L.C.J. and S.S.J. conceptualized the study, secured funding, and reviewed and edited the manuscript. L.L. developed the database and reviewed and edited the manuscript. S.S.J. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.