Challenges and Approaches to Recruitment for and Retention in a Dyad-Focused eHealth Intervention During COVID-19: Randomized Controlled Trial.

IF 5.8 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Journal of Medical Internet Research Pub Date : 2024-12-03 DOI:10.2196/51877

Chunxuan Ma, Rachel H Adler, Daria B Neidre, Ronald C Chen, Laurel L Northouse, Christine Rini, Xianming Tan, Lixin Song

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引用次数: 0

Abstract

Background: Family-based randomized controlled trials (RCTs) encounter recruitment and retention challenges. Cancer-focused RCTs typically recruit convenience samples from local cancer centers and hospitals.

Objective: This study aimed to examine the recruitment and retention of a population-based, patient-partner dyad cohort in an RCT testing a dyadic eHealth intervention to improve the quality of life in patients with prostate cancer and their partners.

Methods: In this 2-arm, parallel-group RCT, men who recently completed treatment for localized prostate cancer statewide were recruited through North Carolina Central Cancer Registry rapid case ascertainment between April 2018 and April 2021, coinciding with the COVID-19 pandemic. Patient-partner dyads underwent baseline assessments and were randomly assigned to either the intervention or control groups. Follow-up surveys were conducted at 4, 8, and 12 months after baseline. Descriptive and logistic regression analyses were used to achieve the study's aims.

Results: Of the 3078 patients referred from rapid case ascertainment, 2899 were screened. A total of 357 partners were approached after obtaining the eligible patients' permission, 280 dyads completed baseline assessments and were randomized (dyad enrollment rate: 85.11%, 95% CI 81.3%-88.9%), and 221 dyads completed the 12-month follow-up (retention rate: 78.93%, 95% CI 74.2%-83.7%). Regarding the factors associated with retention, compared with White participants, people self-reporting as "other races" (including American Indian, Asian, and multiracial) were more likely to drop out of the study (odds ratio 2.78, 95% CI 1.10-7.04), and older participants were less likely to withdraw (odds ratio 0.96, 95% CI 0.92-0.99).

Conclusions: Despite the negative impact of the pandemic, we successfully recruited enough patient-partner dyads to test our RCT hypotheses. Our recruitment and retention rates were equivalent to or higher than those in most dyadic intervention studies. A well-functioning research team and specific strategies (eg, eHealth intervention, internet phone, and online surveys) facilitated the recruitment and retention of patients with prostate cancer and their partners during the unprecedented pandemic.

Trial registration: ClinicalTrials.gov NCT03489057; https://clinicaltrials.gov/study/NCT03489057.

International registered report identifier (irrid): RR2-https://doi.org/10.1186/s13063-021-05948-5.

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在COVID-19期间以双目标为中心的电子卫生干预中招募和保留的挑战和方法：随机对照试验

背景：基于家庭的随机对照试验（RCTs）面临招募和保留的挑战。以癌症为重点的随机对照试验通常从当地癌症中心和医院招募方便的样本。目的：本研究旨在检验一项基于人群的患者-伴侣双组队列的招募和保留情况，该随机对照试验测试了双组电子健康干预以改善前列腺癌患者及其伴侣的生活质量。方法：在这项双组平行随机对照试验中，通过北卡罗莱纳州中央癌症登记处快速病例确定，在2018年4月至2021年4月期间招募了最近在全州范围内完成局部前列腺癌治疗的男性，与COVID-19大流行相吻合。患者-伴侣二人组进行基线评估，并随机分配到干预组或对照组。在基线后4、8和12个月进行随访调查。使用描述性和逻辑回归分析来实现研究的目标。结果：在快速确诊的3078例患者中，筛选出2899例。在获得符合条件的患者许可后，共接触了357名伴侣，280对完成了基线评估并被随机化（成对入组率：85.11%,95% CI 81.3%-88.9%）， 221对完成了12个月的随访（保留率：78.93%,95% CI 74.2%-83.7%）。关于与保留相关的因素，与白人参与者相比，自我报告为“其他种族”的人（包括美洲印第安人、亚洲人和多种族）更有可能退出研究（优势比2.78,95% CI 1.10-7.04），年龄较大的参与者退出研究的可能性较小（优势比0.96,95% CI 0.92-0.99）。结论：尽管大流行的负面影响，我们成功地招募了足够的患者-伴侣二对来检验我们的随机对照试验假设。我们的招募率和保留率与大多数二元干预研究相当或更高。一个运作良好的研究小组和具体战略（如电子保健干预、互联网电话和在线调查）有助于在前所未有的大流行期间招募和留住前列腺癌患者及其伴侣。试验注册：ClinicalTrials.gov NCT03489057；https://clinicaltrials.gov/study/NCT03489057.International注册报表标识符（irrid）： RR2-https://doi.org/10.1186/s13063-021-05948-5。

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来源期刊

Journal of Medical Internet Research 医学-卫生保健

CiteScore

14.40

自引率

5.40%

发文量

654

审稿时长

1 months

期刊介绍： The Journal of Medical Internet Research (JMIR) is a highly respected publication in the field of health informatics and health services. With a founding date in 1999, JMIR has been a pioneer in the field for over two decades. As a leader in the industry, the journal focuses on digital health, data science, health informatics, and emerging technologies for health, medicine, and biomedical research. It is recognized as a top publication in these disciplines, ranking in the first quartile (Q1) by Impact Factor. Notably, JMIR holds the prestigious position of being ranked #1 on Google Scholar within the "Medical Informatics" discipline.