E-HEalth treatment in Long-term Dialysis (E-HELD): study protocol for a multicenter randomized controlled trial evaluating personalized Internet-based cognitive-behavioral therapy in dialysis patients
Trials, vol. 23, pp. 477
Abstract
BACKGROUND: Kidney failure and dialysis treatment have a large impact on a patient's life. Patients experience numerous, complex symptoms and usually have multiple comorbid conditions. Despite the multitude of problems, patients often have priorities for improvement of specific aspects of their functioning, which would be helpful for clinicians to become informed of. This highlights a clear need for patient-centered care in this particular patient group, with routine screening as a vital element to timely recognize symptoms and tailored treatment to match individual patients' needs and priorities. By also providing feedback on patient's screening results to the patient itself, the patient is empowered to actively take control in one's mostly uncontrollable disease process. The current paper describes the study design of a multicenter randomized controlled trial evaluating the effectiveness of the "E-HEealth treatment in Long-term Dialysis" (E-HELD) intervention. This therapist-guided Internet-based cognitive-behavioral therapy (ICBT) intervention is focused on and personalized to the myriad of problems that dialysis patients experience and prioritize. METHODS: After a screening procedure on adjustment problems, 130 eligible dialysis patients will be randomized to care as usual or the E-HELD intervention. Patients will complete questionnaires on distress (primary outcome measure), several domains of functioning (e.g., physical, psychological, social), potential predictors and mediators of treatment success, and the cost-effectiveness of the intervention, at baseline, 6-month follow-up, and 12-month follow-up. In addition, to take account of the personalized character of the intervention, the Personalized Priority and Progress Questionnaire (PPPQ) will be administered which is a personalized instrument to identify, prioritize, and monitor individual problems over time. DISCUSSION: The present study design will provide insight in the effectiveness of tailored ICBT in patients with kidney failure who are treated with dialysis. When proven effective, the screening procedure and the subsequent ICBT intervention could be implemented in routine care to detect, support, and treat patients struggling with adjustment problems. TRIAL REGISTRATION: NL63422.058.17 [Registry ID: METC-LDD] NL7160 [Netherlands Trial Register; registered on 16 July 2018].
Authors 7
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Judith Tommel corresponding Aachen Health Medical and Neuropsychology Unit Institute of Psychology Faculty of Social and Behavioural Sciences
Affiliation as printed
Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Wassenaarseweg 52, 2333 AK, Leiden, the Netherlands. j.tommel@fsw.leidenuniv.nl
Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Wassenaarseweg 52, 2333 AK, Leiden, the Netherlands
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Andrea W.M. Evers Aachen Health Medical and Neuropsychology Unit Institute of Psychology Faculty of Social and Behavioural Sciences
Affiliation as printed
Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Wassenaarseweg 52, 2333 AK, Leiden, the Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Health Sciences
Affiliation as printed
Department of Nephrology, Radboud Institute for Health Sciences, Radboud university medical center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Public Health and Primary Care, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands
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Lieke Wirken Aachen Health Medical and Neuropsychology Unit Institute of Psychology Faculty of Social and Behavioural Sciences
Affiliation as printed
Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Wassenaarseweg 52, 2333 AK, Leiden, the Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Health Sciences
Affiliation as printed
Department of Nephrology, Radboud Institute for Health Sciences, Radboud university medical center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands
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Henriët van Middendorp Aachen Health Medical and Neuropsychology Unit Institute of Psychology Faculty of Social and Behavioural Sciences
Affiliation as printed
Health, Medical and Neuropsychology Unit, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Wassenaarseweg 52, 2333 AK, Leiden, the Netherlands
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