Attitudes toward Potential Participant Registries
Authors: Grill, Joshua D. | Holbrook, Andrew | Pierce, Aimee | Hoang, Dan | Gillen, Daniel L.
Article Type: Research Article
Abstract: Difficult participant recruitment is a consistent barrier to successful medical research. Potential participant registries represent an increasingly common intervention to overcome this barrier. A variety of models for registries exist, but few data are available to instruct their design and implementation. To provide such data, we surveyed 110 cognitively normal research participants enrolled in a longitudinal study of aging and dementia. Seventy-four (67%) individuals participated in the study. Most (78%, CI: 0.67, 0.87) participants were likely to enroll in a registry. Willingness to participate was reduced for registries that required enrollment through the Internet using a password (26%, CI: 0.16, …0.36) or through email (38%, CI: 0.27, 0.49). Respondents acknowledged their expectations that researchers share information about their health and risk for disease and their concerns that their data could be shared with for-profit companies. We found no difference in respondent preferences for registries that shared contact information with researchers, compared to honest broker models that take extra precautions to protect registrant confidentiality (28% versus 30%; p = 0.46). Compared to those preferring a shared information model, respondents who preferred the honest broker model or who lacked model preference voiced increased concerns about sharing registrant data, especially with for-profit organizations. These results suggest that the design of potential participant registries may impact the population enrolled, and hence the population that will eventually be enrolled in clinical studies. Investigators operating registries may need to offer particular assurances about data security to maximize registry enrollment but also must carefully manage participant expectations. Show more
Keywords: Clinical trial, recruitment, registries
DOI: 10.3233/JAD-160873
Citation: Journal of Alzheimer's Disease, vol. 56, no. 3, pp. 939-946, 2017
Constructing a Local Potential Participant Registry to Improve Alzheimer’s Disease Clinical Research Recruitment
Authors: Grill, Joshua D. | Hoang, Dan | Gillen, Daniel L. | Cox, Chelsea G. | Gombosev, Adrijana | Klein, Kirsten | O’Leary, Steve | Witbracht, Megan | Pierce, Aimee
Article Type: Research Article
Abstract: Potential participant registries are tools to address the challenge of slow recruitment to clinical research. In particular, registries may aid recruitment to secondary prevention clinical trials for Alzheimer’s disease (AD), which enroll cognitively normal older individuals meeting specific genetic or biomarker criteria. Evidence of registry effectiveness is sparse, as is guidance on optimal designs or methods of conduct. We report our experiences of developing a novel local potential participant registry that implemented online enrollment and data collection. In the first year of operation, 957 individuals submitted email addresses to the registry, of whom 592 self-reported demographic, family history, and medical …data. In addition, registrants provided information related to their interest and willingness to be contacted about studies. Local earned media and community education were the most effective methods of recruitment into the registry. Seventy-six (26%) of 298 registrants contacted about studies in the first year enrolled in those studies. One hundred twenty-nine registrants were invited to enroll in a preclinical AD trial, of whom 25 (18%) screened and 6 were randomized. These results indicate that registries can aid recruitment and provide needed guidance for investigators initiating new local registries. Show more
Keywords: Clinical trial, preclinical Alzheimer’s disease, recruitment, registries
DOI: 10.3233/JAD-180069
Citation: Journal of Alzheimer's Disease, vol. 63, no. 3, pp. 1055-1063, 2018