Dutch nOcturnal and hoME dialysis Study to Improve Clinical Outcomes (DOMESTICO): Rationale and design

A. Van Eck Van Der Sluijs, A. A. Bonenkamp, F. W. Dekker, A. C. Abrahams, B. C. Van Jaarsveld, the DOMESTICO study group

Research output: Contribution to journalArticleAcademicpeer-review

19 Citations (Scopus)
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Abstract

Background: More than 6200 End Stage Renal Disease patients in the Netherlands are dependent on dialysis, either performed at home or in a dialysis centre. Visiting a dialysis centre three times a week is considered a large burden by many patients. However, recent data regarding the effects of dialysis at home on quality of life, clinical outcomes, and costs compared with in-centre haemodialysis are lacking. Methods: The Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO) is a nationwide, prospective, observational cohort study that will include adult patients starting with a form of dialysis. Health-related quality of life, as the primary outcome, clinical outcomes and costs, as secondary outcomes, will be measured every 3-6 months in patients on home dialysis, and compared with a control group consisting of in-centre haemodialysis patients. During a 3-year period 800 home dialysis patients (600 peritoneal dialysis and 200 home haemodialysis patients) and a comparison group of 800 in-centre haemodialysis patients will be included from 53 Dutch dialysis centres (covering 96% of Dutch centres) and 1 Belgian dialysis centre (covering 4% of Flemish centres). Discussion: DOMESTICO will prospectively investigate the effect of home dialysis therapies on health-related quality of life, clinical outcomes and costs, in comparison with in-centre haemodialysis. The findings of this study are expected to ameliorate the shared decision-making process and give more guidance to healthcare professionals, in particular to assess which type of patients may benefit most from home dialysis. Trial registration: The DOMESTICO study is registered with the National Trial Register on (number: NL6519, date of registration: 22 August 2017) and the Central Committee on Research Involving Human Subjects (CCMO) (number: NL63277.029.17).

Original languageEnglish
Article number361
JournalBMC Nephrology
Volume20
Issue number1
DOIs
Publication statusPublished - 18 Sept 2019

Bibliographical note

Funding Information:
This study is supported by grants of ZonMw, Fresenius Medical Care Deutschland GmbH, Baxter Netherlands BV, and Dirinco. The grant of ZonMw is provided from the ‘Health care efficiency research’ programme and focusses on the part of this study concerning health-related quality of life. ZonMw has independently peer reviewed the study protocol. With the Fresenius Medical Care Deutschland GmbH grant, clinical outcomes will be investigated, and the grant of Baxter focusses on costs and cost-effectiveness. The sponsors did not play a role in the study design and the preparation of this article.

Publisher Copyright:
© 2019 The Author(s).

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