Effects of Technology Assisted Stepped Collaborative Care Intervention to Improve Symptoms in Patients Undergoing Hemodialysis: The TĀCcare Randomized Clinical Trial.

Effects of Technology Assisted Stepped Collaborative Care Intervention to Improve Symptoms in Patients Undergoing Hemodialysis: The TĀCcare Randomized Clinical Trial.
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DOI:
10.1001/jamainternmed.2023.2215
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发表时间:
2023-08-01
影响因子:
39
通讯作者:
Unruh, Mark
Unruh, Mark
中科院分区:
医学1区
文献类型:
--
作者:
Jhamb, Manisha;Steel, Jennifer L.;Yabes, Jonathan G.;Roumelioti, Maria-Eleni;Erickson, Sarah;Devaraj, Susan M.;Vowles, Kevin E.;Vodovotz, Yoram;Beach, Scott;Weisbord, Steven D.;Rollman, Bruce L.;Unruh, Mark

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通过远程医疗提供的包括心理治疗或药物治疗在内的阶梯式协作护理干预是否能改善长期进行血液透析的终末期肾病(ESKD)患者的疲劳、疼痛或抑郁症状?这项随机临床试验对160名接受血液透析的ESKD患者进行了至少中等程度的疲劳、疼痛或抑郁,结果发现,在血液透析期间或在家与健康教育对照相比,采用分步协同护理干预治疗可显著改善疲劳和疼痛。这些研究结果表明,这种阶梯式协同护理干预是治疗ESKD长期血液透析患者疲劳和疼痛的显著有效方法。接受长期血液透析的终末期肾病(ESKD)患者通常会经历衰弱症状的沉重负担,而有效的治疗选择有限。比较阶梯式协同护理干预与注意控制在长期血液透析的ESKD患者中减轻疲劳、疼痛和抑郁的有效性。技术辅助阶梯式协同护理(TĀCcare)是一项平行组、单盲、随机临床试验,研究对象是接受长期血液透析并经历临床显著水平的疲劳、疼痛和/或抑郁且正在考虑治疗的成人(≥18岁)患者。该试验于2018年3月1日至2022年6月31日在美国两个州(新墨西哥州和宾夕法尼亚州)进行。数据分析时间为2022年7月1日至2023年4月10日。干预组接受每周12次的认知行为治疗,通过远程医疗在血液透析病房或患者家中进行,和/或与透析和初级保健团队合作采用分步方法进行药物治疗。注意控制组接受6次远程健康教育。主要结果是3个月时疲劳(使用慢性疾病治疗疲劳功能评估测量)、平均疼痛严重程度(简短疼痛量表)和/或抑郁(贝克抑郁量表- ii)评分的变化。随访12个月,评估干预措施的维持效果。160名参与者(平均[SD]年龄为58岁,女性72人[45%],男性88人[55%],美洲印第安人21人[13%],黑人45人[28%],西班牙裔28人[18%],白人83人[52%])随机分组,干预组83人,对照组77人。在意向治疗分析中,与对照组相比,干预组患者的疲劳程度有统计学意义和临床意义的显著降低(平均差异[md], 2.81; 95% CI, 0.86 ~ 4.75; P =。01)和疼痛严重程度(md, - 0.96; 95% CI, - 1.70 ~ - 0.23; P =。2) 3个月。这些效果持续到6个月(md, 3.73; 95% CI, 0.87至6.60;P = 0.03; BPI, - 1.49; 95% CI, - 2.58至- 0.40;P = 0.02)。3个月时抑郁症的改善有统计学意义,但很小(md为- 1.73;95% CI为- 3.18至- 0.28;P = 0.02)。两组不良事件相似。这项随机临床试验发现,在血液透析期间,与对照组相比,技术辅助的阶梯式协作护理干预在3个月时对疲劳和疼痛产生了适度但有临床意义的改善,效果持续到6个月。这项随机临床试验评估了在血液透析期间提供的阶梯式协作护理干预对改善终末期肾病患者的疼痛、疲劳和抑郁的影响。
Does a stepped collaborative care intervention including psychotherapy or pharmacotherapy delivered via telehealth improve symptoms of fatigue, pain, or depression among patients with end-stage kidney disease (ESKD) who are undergoing long-term hemodialysis? This randomized clinical trial of 160 patients with ESKD undergoing hemodialysis with at least moderate levels of fatigue, pain, or depression found that treatment with a stepped collaborative care intervention delivered during hemodialysis or at home vs health education control resulted in clinically significant improvements in fatigue and pain. These findings show that this stepped collaborative care intervention is a significantly effective treatment for fatigue and pain in patients undergoing long-term hemodialysis for ESKD. Patients with end-stage kidney disease (ESKD) undergoing long-term hemodialysis often experience a high burden of debilitating symptoms for which effective treatment options are limited. To compare the effectiveness of a stepped collaborative care intervention vs attention control for reducing fatigue, pain, and depression among patients with ESKD undergoing long-term hemodialysis. Technology Assisted Stepped Collaborative Care (TĀCcare) was a parallel-group, single-blinded, randomized clinical trial of adult (≥18 years) patients undergoing long-term hemodialysis and experiencing clinically significant levels of fatigue, pain, and/or depression for which they were considering treatment. The trial took place in 2 US states (New Mexico and Pennsylvania) from March 1, 2018, to June 31, 2022. Data analyses were performed from July 1, 2022, to April 10, 2023. The intervention group received 12 weekly sessions of cognitive behavioral therapy delivered via telehealth in the hemodialysis unit or patient home, and/or pharmacotherapy using a stepped approach in collaboration with dialysis and primary care teams. The attention control group received 6 telehealth sessions of health education. The coprimary outcomes were changes in fatigue (measured using the Functional Assessment of Chronic Illness Therapy Fatigue), average pain severity (Brief Pain Inventory), and/or depression (Beck Depression Inventory-II) scores at 3 months. Patients were followed up for 12 months to assess maintenance of intervention effects. There were 160 participants (mean [SD] age, 58 [14] years; 72 [45%] women and 88 [55%] men; 21 [13%] American Indian, 45 [28%] Black, 28 [18%] Hispanic, and 83 [52%] White individuals) randomized, 83 to the intervention and 77 to the control group. In the intention-to-treat analyses, when compared with controls, patients in the intervention group experienced statistically and clinically significant reductions in fatigue (mean difference [md], 2.81; 95% CI, 0.86 to 4.75; P = .01) and pain severity (md, −0.96; 95% CI, −1.70 to −0.23; P = .02) at 3 months. These effects were sustained at 6 months (md, 3.73; 95% CI, 0.87 to 6.60; P = .03; and BPI, −1.49; 95% CI, −2.58 to −0.40; P = .02). Improvement in depression at 3 months was statistically significant but small (md −1.73; 95% CI, −3.18 to −0.28; P = .02). Adverse events were similar in both groups. This randomized clinical trial found that a technology assisted stepped collaborative care intervention delivered during hemodialysis led to modest but clinically meaningful improvements in fatigue and pain at 3 months vs the control group, with effects sustained until 6 months. ClinicalTrials.gov Identifier: NCT03440853 This randomized clinical trial evaluates the effects of a stepped collaborative care intervention delivered during hemodialysis to improve pain, fatigue, and depression in patients with end-stage kidney disease.
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