Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.
Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA.
Contemp Clin Trials. 2022 Nov;122:106956. doi: 10.1016/j.cct.2022.106956. Epub 2022 Oct 5.
Self-care behaviors help reduce hemoglobin A1c (HbA1c) and prevent or delay type 2 diabetes (T2D) complications. Individualized interventions that support goal setting and self-monitoring improve self-care and HbA1c in the short-term; engaging family and friends may enhance and/or sustain effects. Family/Friend Activation to Motivate Self-care (FAMS) is a mobile phone-delivered intervention (i.e., phone coaching and text message support) based on Family Systems Theory which was successfully piloted among diverse adults with T2D.
We made improvements to FAMS and conducted iterative usability testing to finalize FAMS 2.0 before evaluation in a randomized controlled trial (RCT). Adult persons with diabetes (PWDs) who enrolled were asked to invite a support person (friend or family member) to participate alongside them. For the RCT, dyads were randomly assigned to FAMS 2.0 or enhanced treatment as usual (control) for the first 9 months of the 15-month trial. Outcomes include PWDs' HbA1c and psychosocial well-being (including diabetes distress) and support persons' own diabetes distress and support burden.
We recruited RCT participants from April 2020 through October 2021 (N = 338 PWDs with T2D; 89% [n = 300] with a support person). PWDs were 52% male, 62% non-Hispanic White, aged 56.9 ± 11.0 years with HbA1c 8.7% ± 1.7% at enrollment; 73% cohabitated with their enrolled support person. Data collection is ongoing through January 2023.
Findings will inform the utility of engaging family/friends in self-care behaviors for both PWD and support person outcomes. Using widely available mobile phone technology, FAMS 2.0, if successful, has potential for scalability.
ClinicalTrials.gov identifier: NCT04347291 posted April 15, 2020.
自我护理行为有助于降低血红蛋白 A1c（HbA1c）并预防或延缓 2 型糖尿病（T2D）并发症。支持目标设定和自我监测的个性化干预措施可在短期内改善自我护理和 HbA1c；让家人和朋友参与进来可能会增强和/或维持效果。基于家庭系统理论的手机为基础的家庭/朋友激活以促进自我护理（FAMS）是一种干预措施（即电话辅导和短信支持），已在不同的 2 型糖尿病患者中进行了试点。
我们对 FAMS 进行了改进，并进行了迭代可用性测试，以在随机对照试验（RCT）之前确定 FAMS 2.0。参与的糖尿病患者（PWD）被要求邀请一位支持人员（朋友或家庭成员）与他们一起参与。对于 RCT，在 15 个月的试验的前 9 个月中，将对偶随机分配到 FAMS 2.0 或增强的常规治疗（对照组）。结果包括 PWD 的 HbA1c 和心理社会健康（包括糖尿病困扰）以及支持人员自己的糖尿病困扰和支持负担。
我们于 2020 年 4 月至 2021 年 10 月招募了 RCT 参与者（N=338 例患有 2 型糖尿病的 PWD；89%[n=300]有支持人员）。PWD 为 52%男性，62%非西班牙裔白人，年龄 56.9±11.0 岁，入组时 HbA1c 为 8.7%±1.7%；73%与入组支持人员同住。数据收集正在进行中，截至 2023 年 1 月。
研究结果将为 PWD 和支持人员的自我护理行为提供有用的信息。如果 FAMS 2.0 成功，它将利用广泛可用的手机技术，具有扩展的潜力。
ClinicalTrials.gov 标识符：NCT04347291，于 2020 年 4 月 15 日发布。
