Effects of Technology Assisted Stepped Collaborative Care Intervention to Improve Symptoms in Patients Undergoing Hemodialysis

Abstract

ImportancePatients 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.ObjectiveTo 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 ParticipantsTechnology 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.InterventionsThe 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 MeasuresThe 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.ResultsThere 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 RelevanceThis 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 RegistrationClinicalTrials.gov Identifier: NCT03440853

Impact of Nutrition Education on Various Health-Related Components of Hemodialysis Patients: A Systematic Review

“…The studies in our review were subject to certain limitations. This included insufficient results to draw any conclusions [ 12 ], challenges in generalizing the findings [ 13 , 15 , 27 , 35 , 48 , 50 , 51 ], language difficulties among patients [ 13 ], a lack of detail on the effect of the intervention elements [ 13 ], the possibility of contamination of information between patient groups [ 14 , 19 , 34 , 44 ], uncontrolled variables [ 14 , 21 , 22 , 26 , 29 , 31 , 37 ], short duration of studies, interventions, or follow-up [ 15 , 19 , 27 , 30 , 35 , 41 , 51 ], the patients already being familiar with educational content [ 17 ], small sample size [ 29 , 30 , 37 , 41 , 46 , 49 , 52 ], self-selection bias [ 52 ], not all information being analyzed [ 20 , 48 ], subjective results linked to patient declarations [ 23 ], inaccurate assessment tools [ 42 ], possible Hawthorne effect [ 30 ], interventions conducted in a single center [ 30 , 41 ], and the possibility of social desirability effect bias [ 39 ,…”

Associations between Social Support and Patient-Reported Outcomes in Patients Receiving Hemodialysis

“…Details of the study design have been reported elsewhere. 17 This study was approved by the University of Pittsburgh's Institutional Review Board and the University of New Mexico's Human Research Review Committee. Participants were treated in accordance with the Declaration of Helsinki.…”

Correlates of Rates and Treatment Readiness for Depressive Symptoms, Pain, and Fatigue in Hemodialysis Patients: Results from the TĀCcare Study

“…Details of the study design and primary outcome results have been reported elsewhere. 19 Adult (18 years or older), English-speaking patients undergoing thrice-weekly maintenance HD for .3 months from 14 free-standing dialysis clinics (Dialysis Clinic, Inc.) participated in symptom screening. Those with evidence of thought disorder, delusions, or active suicidal intent; active substance abuse; too ill or cognitively impaired to participate based on clinicians' judgment; anticipated life expectancy of ,1 year; scheduled for living donor kidney transplant; or relocating to another dialysis unit within 6 months were excluded.…”

“…The Technology Assisted stepped Collaborative Care (TĀCcare) study was a multicenter randomized controlled trial (RCT) designed to compare the effectiveness of a stepped collaborative care intervention for symptom management in HD patients. 18 , 19 Given the high prevalence and cooccurrence, negative health effect, and lack of treatment options, the symptom cluster of fatigue, pain, and depression was targeted in the RCT. The main objective of this report was to identify differences in rates of symptom burden and readiness to engage in treatment by sociodemographic factors in HD patients.…”