Background: Clinical depression and postdialysis fatigue are important concerns for patients with kidney failure and can have a negative impact on quality of life and survival. Study Design: The FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study is an ongoing prospective cohort study investigating the clinical and economic benefits of daily (6 times per week) hemodialysis (HD). In this interim report, as part of an a priori planned analysis, we examine the long-term impact of daily HD on depressive symptoms, measured using the Beck Depression Inventory (BDI) survey, and postdialysis recovery time, measured using a previously validated questionnaire. Setting & Participants: Adult patients initiating daily HD with a planned 12-month follow-up. Outcomes & Measurements: The BDI survey and postdialysis recovery time question were administered at baseline, and changes were assessed at months 4 and 12. Results: 239 participants were enrolled (intention-to-treat cohort) and 128 completed the study (per-protocol cohort). Mean age was 52 years, 64% were men, 55% had an arteriovenous fistula, and 90% transitioned from in-center HD therapy. In the per-protocol cohort, there was a significant decrease in mean BDI score over 12 months (11.2 [95% CI, 9.6-12.9] vs 7.8 [95% CI, 6.5-9.1]; P < 0.001). For robustness, the intention-to-treat analysis was performed, yielding similar results. The percentage of patients with depressive symptoms (BDI score >10) significantly decreased during 12 months (41% vs 27%; P = 0.03). Similarly, in the per-protocol cohort, there was a significant decrease in postdialysis recovery time over 12 months (476 [95% CI, 359-594] vs 63 minutes [95% CI, 32-95]; P < 0.001). The intention-to-treat analysis yielded similar results. The percentage of patients experiencing prolonged postdialysis recovery time (≥60 minutes) also significantly decreased (81% vs 35%; P = 0.001). Limitations: Observational study with lack of control arm. Conclusions: Daily HD is associated with long-term improvement in depressive symptoms and postdialysis recovery time.
Bibliographical noteFunding Information:
Financial Disclosure: The FREEDOM Study is sponsored and funded by NxStage Medical Inc , the manufacturer of the home hemodialysis device used by the FREEDOM Study participants. Drs Collins, Finkelstein, Hull, Jaber, Kraus, McCarthy, Miller, and Spry are members of the Scientific Advisory Board of NxStage Medical Inc.
Copyright 2010 Elsevier B.V., All rights reserved.
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