Carroll Megan K, Faheem Safa, Bouteiller Jean, Hernandez Adrian, Mahaffey Kenneth W, Mega Jessica L, Pagidipati Neha, Schaack Terry, Shah Svati H, Shashidhar Sumana, Swope Susan, Williams Donna, Plowman R Scooter, Simard Edgar P, Short Sarah A, Sullivan Shannon S
Verily Life Sciences, South San Francisco, CA, United States.
Duke University, Durham, NC, United States.
Front Digit Health. 2025 Jun 24;7:1520132. doi: 10.3389/fdgth.2025.1520132. eCollection 2025.
To evaluate remote participant engagement in a clinical study over time, based on data from the Project Baseline Health Study (PBHS), a hybrid in-person and virtual study.
The PBHS enrolled 2,502 adult US residents from March 3, 2017 to April 26, 2019, with a ≤5-year follow-up. We summarized 4-year retention and rates of longitudinal patient-reported outcome survey completion. We investigated participant characteristics for their associations with quarterly remote survey completion using regression models.
Of the total participants ( = 2,502), 94% remained enrolled after 4 years and 60% completed all annual visits; 2,490 participants stayed enrolled for at least one quarter. The median (IQR) number of remote electronic survey sets completed was 8 (3-12), of a possible 16. Age [odds ratio (OR), >70 vs. ≤30 years: 2.56; 95% CI: 2.24-2.94] and education (OR, advanced degree vs. ≤high school: 1.36; 95% CI: 1.22-1.52) were positively associated with remote survey completion. Participants with lower odds of completion were Black (OR vs. White: 0.73; 95% CI: 0.67-0.80), Hispanic (OR vs. non-Hispanic: 0.84; 95% CI: 0.77-0.93), or had at least mild symptoms of depression (OR vs. without: 0.90; 95% CI: 0.84-0.96) or anxiety (OR vs. without: 0.84; 95% CI: 0.78-0.90).
Overall, 94% of PBHS participants remained enrolled after four years. Age, race, ethnicity, income, education, and symptomatic depression/anxiety were significantly associated with longitudinal remote questionnaire completion. These findings on engagement over time may inform future longitudinal study design.
Clinicaltrials.gov, identifier (NCT03154346).
基于“基线健康项目研究”(PBHS)的数据,评估远程参与者在一项临床研究中随时间推移的参与情况,该研究是一项线下和虚拟相结合的研究。
PBHS在2017年3月3日至2019年4月26日期间招募了2502名美国成年居民,并进行了为期≤5年的随访。我们总结了4年的留存率以及纵向患者报告结局调查的完成率。我们使用回归模型研究参与者特征与季度远程调查完成情况之间的关联。
在全部参与者(n = 2502)中,94%在4年后仍保持参与状态,60%完成了所有年度访视;2490名参与者至少参与了一个季度。在可能的16次远程电子调查中,完成的中位数(四分位间距)为8次(3 - 12次)。年龄[优势比(OR),>70岁与≤30岁相比:2.56;95%置信区间:2.24 - 2.94]和教育程度(OR,高等学位与≤高中相比:1.36;95%置信区间:1.22 - 1.52)与远程调查完成情况呈正相关。完成可能性较低的参与者为黑人(与白人相比OR:0.73;95%置信区间:0.67 - 0.80)、西班牙裔(与非西班牙裔相比OR:0.84;95%置信区间:0.77 - 0.93),或至少有轻度抑郁症状(与无抑郁症状相比OR:0.90;95%置信区间:0.84 - 0.96)或焦虑症状(与无焦虑症状相比OR:0.84;95%置信区间:0.78 - 0.90)。
总体而言,94%的PBHS参与者在4年后仍保持参与状态。年龄、种族、民族、收入、教育程度以及有症状的抑郁/焦虑与纵向远程问卷完成情况显著相关。这些关于随时间推移参与情况的发现可能为未来纵向研究设计提供参考。
Clinicaltrials.gov,标识符(NCT03154346)。