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CompletedNCT01671228YoDDAUpdated May 1, 2014

Developing and Evaluating the Yorkshire Dialysis Decision Aid

A Phase 1 interventional study of Decision Aid and Decision aid + patient stories in Chronic Kidney Failure, sponsored by University of Leeds. Completed at 6 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-01.

Sponsored by University of Leeds · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
488
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Chronic Kidney Failure

Keywords

  • dialysis
  • chronic kidney failure
  • informed choice
  • patient decision making
  • decision aid
03

In context

Kidney Failure, Chronic

2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.

This study's enrollment of 488 is above the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

University of Leeds is the lead sponsor of 206 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

-

Exclusion Criteria: Those not literate in English

-

05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
488 participants (actual)

Study arms

  • Experimental
    decision aid

    The Yorkshire Dialysis Decision Aid (YoDDA). Delivered as a leaflet in clinic and a web resource outside the NHS.

    Other: Decision Aid

  • Experimental
    Decision Aid + values task

    The Yorkshire Dialysis Decision Aid (YoDDA) + values clarification questions. delivered as a leaflet in clinic and a web-based resource outside the NHS.

    Other: Decision Aid · Other: Decision Aid + values task

  • Experimental
    Decision Aid + patient stories

    The Yorkshire Dialysis Decision Aid (YoDDA) + patient stories. Delivered as an web-based resource outside the NHS.

    Other: Decision Aid · Other: Decision aid + patient stories

  • No intervention
    usual predialysis education

    The consultations and information usually provided by the predialysis health professionals

Interventions

  • OtherDecision Aid

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

  • OtherDecision aid + patient stories

    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

  • OtherDecision Aid + values task

    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)

06

What researchers measure

Primary outcomes

  1. Preparation for decision making scale

    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

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

Secondary outcomes

  1. Usefulness of information

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

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

Other outcomes

  1. Dialysis treatment preferences

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

    Time frame: one week and six weeks after the information

07

Study locations

6 sites
  • Hull and East Yorkshire Hospital Trust
    Hull, East Yorkshire HU3 2JZ, United Kingdom
  • Sheffield Northern General Teaching Hospital
    Sheffield, South Yorkshire S57AU, United Kingdom
  • St James University Hospital
    Leeds, West Yorkshire LS97TF, United Kingdom
  • Bradford Teaching Hospital
    Bradford, Yorkshire BD5 0NA, United Kingdom
  • York teaching Hospital NHS Foundation trust
    York, Yorkshire YO31 8HE, United Kingdom
  • Doncaster Royal Infirmary
    Doncaster, DN2 5LT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01671228
Collaborators
Kidney Cancer UK, National Health Service, United Kingdom, Baxter Healthcare Corporation, Foundation for Informed Medical Decision Making
Responsible party
Hilary L Bekker (Senior Lecturer in Behavioural Sciences and Chartered Psychologist, University of Leeds) — Principal investigator
First posted
Aug 23, 2012
Start date
Jan 2011
Primary completion
Mar 2014
Completion
Mar 2014
Last update
May 1, 2014

Study contacts

Hilary L Bekker, PhD
principal investigator · University of Leeds

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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