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Clinical Trial
. 2019 Sep 18;20(1):361.
doi: 10.1186/s12882-019-1526-4.

Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO): rationale and design

A van Eck van der Sluijs  1 , A A Bonenkamp  2 , F W Dekker  3 , A C Abrahams  1 , B C van Jaarsveld  4   5 ; DOMESTICO study group
Collaborators, Affiliations
Clinical Trial

Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO): rationale and design

A van Eck van der Sluijs et al. BMC Nephrol. .

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).

Keywords: Clinical outcomes; Costs; Health-related quality of life; Home dialysis; Home haemodialysis; In-Centre haemodialysis; Peritoneal dialysis.

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Conflict of interest statement

Fresenius Medical Care Deutschland GmbH, Baxter Netherlands BV, and Dirinco support the work of all authors.

Figures

Fig. 1
Fig. 1
Participating centres. The red dots indicate the participating centres: 53 Dutch dialysis centres (covering 96% of Dutch centres) and 1 Belgian dialysis centre
Fig. 2
Fig. 2
Participating patients
See this image and copyright information in PMC

References

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