Effects of technology assisted stepped collaborative care intervention to improve symptoms in patients undergoing hemodialysis. The TĀCcare randomized clinical trial

Manisha Jhamb*, Jennifer L Steel, Jonathan G Yabes, Maria-Eleni Roumelioti, Sarah Erickson, Susan M Devaraj, Kevin E Vowles, Yoram Vodovotz, Scott Beach, Steven D Weisbord, Bruce L Rollman, Mark Unruh

*Corresponding author for this work

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3 Citations (Scopus)
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Abstract

IMPORTANCE: 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.

OBJECTIVE: 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.

DESIGN, SETTING, AND PARTICIPANTS: 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.

INTERVENTIONS: 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.

MAIN OUTCOMES AND MEASURES: 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.

RESULTS: 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.

CONCLUSIONS AND RELEVANCE: 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.

Trial Registration:  ClinicalTrials.gov Identifier: NCT03440853


Original languageEnglish
Article number112924
JournalJAMA Internal Medicine
Volume189
Early online date20 Jun 2023
DOIs
Publication statusEarly online date - 20 Jun 2023

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