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Trials
Published in: Trials 1/2022

01-12-2022 | Care | Study protocol

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

Authors: Judith Tommel, Andrea W. M. Evers, Henk W. van Hamersvelt, Sandra van Dijk, Niels H. Chavannes, Lieke Wirken, Luuk B. Hilbrands, Henriët van Middendorp

Published in: Trials | Issue 1/2022

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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]
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Metadata
Title
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
Authors
Judith Tommel
Andrea W. M. Evers
Henk W. van Hamersvelt
Sandra van Dijk
Niels H. Chavannes
Lieke Wirken
Luuk B. Hilbrands
Henriët van Middendorp
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06392-9

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