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A randomized trial assessing a telehealth intervention suggest such an intervention could improve quality of life among people undergoing dialysis.
A patient-guided intervention using telemedicine could reduce help address burdensome symptoms among people undergoing dialysis, according to the results of a new study.
Named the TĀCcare trial, results of the study, which included data from more than 150 participants with end-stage kidney disease, support use of a technologist assisted stepped collaborative care intention delivered during hemodialysis, with results indicating adherence to such a pgroram could improve symptoms of pain and depression as well as quality of life scores.
“Our patients and their caregivers report pain, fatigue and depression as major issues related to dialysis that affect their participation in life,” said lead investigator Manisha Jhamb, MD, MPH, an associate professor in the Pitt School of Medicine’s Renal-Electrolyte Division.2 “It’s the nephrology community’s responsibility to study interventions that address patients’ mental health and quality of life concerns; otherwise, we are failing our patients. This study is a step in that direction.”
Although the advancements in technology since the turn of the century have ushered in a new era of sharing information, it was not until the COVID-19 pandemic when the idealized role of telemedicine was thrust into the spotlight. Named the Technology Assisted Stepped Collaborative Care (TĀCcare) trial, the current study was led by Jhamb and fellow investigators with the intent of exploring whether use of a stepped collaborative care intervention including psychotherapy or pharmacotherapy delivered electronically might improve symptoms of fatigue, pain, or depression in patients with end-stage kidney disease undergoing long-term hemodialysis.1
With this in mind, investigators designed their study as a parallel-group, single-blinded, randomized clinical trial of adult patients with hemodialysis recruited from 6 dialysis units in Western Pennsylvania and 8 dialysis units in New Mexico between March 2018-December 2021. For inclusion, patients needed to be 18 years of age, receiving in-center, 3-times-weekly hemodialysis, and be experiencing clinically significant levels of fatigue, pain, and/or depression and considering seeking treatment for these symptoms.1
Overall, 160 patients were enrolled in the study. This cohort had a mean age of 58 (Standard deviation [SD], 14) years, 45% were women, and 52% were White individuals. Of the 160 patients included in the study, 83 were randomized to the telemedicine intervention and 77 to the control group. Those randomized to the intervention received 6 telehealth sessions of health education.1
The trial had co-primary endpoints of interest. These endpoints were the were changes in fatigue, average pain severity, and/or depression scores at 3 months. For the purpose of analysis, fatigue was measured using the Functional Assessment of Chronic Illness Therapy Fatigue, pain severity was measured using the Brief Pain Inventory, and depression was measured using the Beck Depression Inventory-II.1
In intention-to-treat analyses, patients in the intervention arm of the study experienced statistically and clinically significant reductions in both fatigue (mean difference [MD], 2.81; 95% confidence interval [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. Further analysis demonstrated these effects were sustained out to 6 months for both fatigue (MD, 3.73; 95% CI, 0.87 to 6.60; P = .03) and pain severity (MD, -1.49; 95% CI, -2.58 to -0.40; P = .02).1
Investigators noted a statistically significant but small effect on depression at 3 months (MD, -1.73; 95% CI, -3.18 to -0.28; P = .02). In subgroup analyses, investigators found no significant difference in effect estimates based on age, sex, race, and time on dialysis, except for a larger reduction in depression scores among women compared with their male counterparts. Additionally, investigators underlined the incidence of adverse events were similar between both study arms.1
“These results are really promising and in the range seen by similar interventions for cancer patients,” Jhamb added.2 “Until now, analgesic medications for pain and recommendations for better sleep and exercise to address fatigue have been the main suggestions we’ve been able to offer our patients, and they haven’t been satisfactory.”