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2型糖尿病自我护理支持干预试验中随机分组前退出与缺乏可参与的支持人员共同参与有关。

Prerandomization withdrawals from a Type 2 diabetes self-care support intervention trial are associated with lack of available support person coparticipant.

作者信息

Roddy McKenzie K, El-Rifai Merna, LeStourgeon Lauren, Aikens James E, Wolever Ruth Q, Greevy Robert A, Mayberry Lindsay S

机构信息

VA Quality Scholars Program, VA Tennessee Valley Healthcare System, Nashville, TN, USA.

Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA.

出版信息

Chronic Illn. 2025 Mar;21(1):105-114. doi: 10.1177/17423953231203734. Epub 2023 Sep 26.

Abstract

ObjectivesDyadic interventions, involving two persons with a preexisting close relationship, offer the opportunity to activate support persons (SPs) to improve health for adults with chronic conditions. Requiring SP coparticipation can challenge recruitment and bias samples; however, the associations between voluntary SP coparticipation and recruitment outcomes across patient characteristics are unknown.MethodsThe Family/Friend Activation to Motivate Self-care 2.0 randomized controlled trial (RCT) enrolled adults with Type 2 diabetes (T2D) from an academic health system. Participants were asked-but not required-to invite an SP to coenroll. Using data from the electronic health record we sought to describe RCT enrollment in the setting of voluntary SP coparticipation.ResultsIn a diverse sample of adults with (T2D) (48% female, 44% minoritized race/ethnicity), most participants (91%) invited SPs and (89%) enrolled with SPs. However, prerandomization withdrawal was significantly higher among participants who did not have consenting SPs than those who did. Females were less likely to invite SPs than males and more Black PWD were prerandomization withdrawals than randomized.DiscussionVoluntary SP coenrollment may benefit recruitment for dyadic sampling; however, more research is needed to understand if these methods systematically bias sampling and to prevent these unintended biases.

摘要

目标

二元干预涉及两个已有亲密关系的人,为促使支持人员(SP)行动起来改善慢性病成年患者的健康状况提供了契机。要求支持人员共同参与可能会给招募工作带来挑战并导致样本偏差;然而,关于自愿支持人员共同参与与不同患者特征的招募结果之间的关联尚不清楚。

方法

“家庭/朋友激励自我护理2.0随机对照试验(RCT)”招募了来自一个学术健康系统的2型糖尿病(T2D)成年患者。参与者被邀请(但并非被要求)邀请一名支持人员共同登记入组。我们利用电子健康记录中的数据来描述在自愿支持人员共同参与情况下的随机对照试验入组情况。

结果

在一个多样化的2型糖尿病成年患者样本中(48%为女性,44%为少数族裔),大多数参与者(91%)邀请了支持人员,并且89%的人与支持人员一起登记入组。然而,在没有获得支持人员同意的参与者中,随机分组前退出的比例显著高于有支持人员同意的参与者。女性比男性邀请支持人员的可能性更小,并且在随机分组前退出的黑人糖尿病患者比随机分组的更多。

讨论

自愿支持人员共同登记入组可能有利于二元抽样的招募工作;然而,需要更多研究来了解这些方法是否会系统性地导致抽样偏差,并防止这些意外偏差。

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