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Completed

NCT Number: NCT01671228

Developing and Evaluating the Yorkshire Dialysis Decision Aid

The purpose of this research is to develop a patient decision aid in paper and web formats to help patients with chronic kidney disease make informed dialysis treatment decisions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hull and East Yorkshire Hospital Trust, Hull, East Yorkshire, United Kingdom

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About this study

This research will develop and evaluate a paper and web resource known as a decision-aid to help patients make informed decisions about dialysis treatment. The Yorkshire Dialysis Decision Aid (YoDDA) will help patients' with chronic kidney disease make informed decisions between haemodialysis and peritoneal dialysis choices by a) re-writing dialysis information in a more meaningful way for patients, b) restructuring information to make this difficult decision more manageable, and c) using prompts to help patients imagine the choices' consequences. The research will assess the acceptability of a patient decision aid in paper and web versions to patients and their carers, and its impact on patients choices about dialysis.

The programme of research included:

A survey using qualitative methods of patients with chronic kidney disease and professionals providing predialysis services to develop the Yorkshire Dialysis Decision Aid content, and integration within usual predialysis care practices.

A before-and-after study was carried out to evaluate the acceptability of the YoDDA-booklet to patients with sustained deterioration of kidney function making dialysis decision across the Yorkshire and Humber region, UK.

An experimental study was carried out on-line to evaluate the acceptability of three versions of YoDDA-web (YoDDA; YoDDA+values tasks; YoDDA_patient videos) to people, or carers of people, with kidney disease. The study was advertised with flyers within UK renal units and notices on the National Kidney Federation's website and members' magazine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients with chronic kidney disease and carers of people with chronic kidney diseae who are making decisions about dialysis treatments.

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Exclusion criteria

Those not literate in English

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Treatment and study plan

Decision Aid

Other

The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format

Decision aid + patient stories

Other

The Yorkshire dialysis decision aid (YoDDA) plus a set of narratives provided by patients on the treatment options (home and hospital haemodialysis; continuous ambulatory and automated peritoneal dialysis

Decision Aid + values task

Other

The Yorkshire Dialysis decision aid (YoDDA) plus a set of questions to help patients explore what aspects of their life important to them about this decision (values clarification)

Primary outcomes

  1. Preparation for decision making scale

    Time frame: one and six weeks after provision information about dialysis choices

    Assesses patient's perception of how useful the resource was in helping patients prepare for a consultation to talk about their health decision (Graham and O'Connor, 2010). http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_PrepDM.pdf

Secondary outcomes

  1. Usefulness of information

    Time frame: one and six weeks after the provision of information

    Study specific items to assess perceived usefulness of information in helping patients understand chronic kidney disease, dialysis treatments and thinking about dialysis

Other outcomes

  1. Dialysis treatment preferences

    Time frame: one week and six weeks after the information

    Study specific measure asking patients to rank order their preferred dialysis treatment (CAPD, APD, home HD, centre HD)

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • Baxter Healthcare Corporation
  • Foundation for Informed Medical Decision Making
  • Kidney Cancer UK
  • National Health Service, United Kingdom

Registry information

Official study title

Development of a Patient Decision Aid (PtDA) to Facilitate Renal Patients Informed Decisions About Dialysis Treatments

Acronym: YoDDA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 23, 2012
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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