Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons.

Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons.
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DOI:
10.1016/j.cct.2022.106956
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发表时间:
2022-11
影响因子:
2.2
通讯作者:
Wolever, Ruth Q.
Wolever, Ruth Q.
中科院分区:
医学4区
文献类型:
--
作者:
Mayberry, Lindsay S.;El-Rifai, Merna;Nelson, Lyndsay A.;Parks, Makenzie;Greevy Jr, Robert A.;LeStourgeon, Lauren;Molli, Samuel;Bergner, Erin;Spieker, Andrew;Aikens, James E.;Wolever, Ruth Q.

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自我保健行为有助于降低糖化血红蛋白 (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控的个性化干预措施可在短期内改善自我保健和 HbA1c;家人和朋友的参与可能会增强和/或维持效果。家人/朋友激活激励自我护理 (FAMS) 是一种基于家庭系统理论的手机干预措施(即电话辅导和短信支持),已在不同的 T2D 成年人中成功试点。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) 进行评估之前最终确定 FAMS 2.0。参加的成年糖尿病患者 (PWD) 被要求邀请一名支持者(朋友或家人)与他们一起参与。对于 RCT,在为期 15 个月的试验的前 9 个月,两组患者被随机分配接受 FAMS 2.0 或照常强化治疗(对照)。结果包括残疾人的 HbA1c 和社会心理健康(包括糖尿病困扰)以及支持人们自身的糖尿病困扰和支持负担。我们从 2020 年 4 月到 2021 年 10 月招募了 RCT 参与者(N = 338 名患有 T2D 的残疾人;89% [n = 300] 有支持人员)。 PWD 中 52% 为男性,62% 为非西班牙裔白人,年龄为 56.9±11.0 岁,入组时 HbA1c 为 8.7%±1.7%; 73% 的人与其登记的支持人员同居。数据收集将持续到 2023 年 1 月。调查结果将告诉您让家人/朋友参与自我护理行为对残疾人和支持人员结果的效用。 FAMS 2.0 使用广泛使用的移动电话技术,如果成功,将具有可扩展性的潜力。 ClinicalTrials.gov 标识符:NCT04347291 发布于 2020 年 4 月 15 日。
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.
DOI: 10.1002/pds.3260
发表时间: 2012-05
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发表时间: 2013-12
期刊: Shanghai archives of psychiatry
影响因子: --
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