Developing and Evaluating the Yorkshire Dialysis Decision Aid (YoDDA)

This study is currently recruiting participants.
Verified August 2012 by University of Leeds
Sponsor:
Collaborators:
Kidney Research UK
National Health Service, United Kingdom
Baxter Healthcare Corporation
Foundation for Informed Medical Decision Making
X-Lab systems, University of Leeds (www.x-labsystems.co.uk)
Information provided by (Responsible Party):
Hilary L Bekker, University of Leeds
ClinicalTrials.gov Identifier:
NCT01671228
First received: August 16, 2012
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Failure
Other: Decision Aid
Other: Decision aid + patient stories
Other: Decision Aid + values task
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Development of a Patient Decision Aid (PtDA) to Facilitate Renal Patients Informed Decisions About Dialysis Treatments

Resource links provided by NLM:


Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Preparation for decision making scale [ Time Frame: one and six weeks after provision information about dialysis choices ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Usefulness of information [ Time Frame: one and six weeks after the provision of information ] [ Designated as safety issue: No ]
    Study specific items to assess perceived usefulness of information in helping patients understand chronic kidney disease, dialysis treatments and thinking about dialysis


Other Outcome Measures:
  • Dialysis treatment preferences [ Time Frame: one week and six weeks after the information ] [ Designated as safety issue: No ]
    Study specific measure asking patients to rank order their preferred dialysis treatment (CAPD, APD, home HD, centre HD)


Estimated Enrollment: 560
Study Start Date: January 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format
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
The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format
Other: Decision 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)
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
The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format
Other: Decision 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671228

Contacts
Contact: Hilary L Bekker, PhD 0113 343 2726 h.l.bekker@leeds.ac.uk
Contact: Martin Wilkie, MD FRCP 0114 271 5327 martin.wilkie@sth.nhs.uk

Locations
United Kingdom
Hull and East Yorkshire Hospital Trust Recruiting
Hull, East Yorkshire, United Kingdom, HU3 2JZ
Contact: Sunil Bhandari       Sunil.Bhandari@hey.nhs.uk   
Principal Investigator: Sunil Bhandari         
Sheffield Northern General Teaching Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S57AU
Contact: Martin Wilkie, MD FRCP    0114 271 5327      
Principal Investigator: Martin Wilkie, MD FRCP         
St James University Hospital Recruiting
Leeds, West Yorkshire, United Kingdom, LS97TF
Contact: Andrew Mooney, PhD FRCP    0113 206 6869    andrew.mooney@leedsth.nhs.uk   
Principal Investigator: Andrew Mooney, PhD FRCP         
Bradford Teaching Hospital Recruiting
Bradford, Yorkshire, United Kingdom, BD5 0NA
Contact: John Stoves       John.Stoves@bthft.nhs.uk   
Principal Investigator: John Stoves         
York teaching Hospital NHS Foundation trust Recruiting
York, Yorkshire, United Kingdom, YO31 8HE
Contact: Colin Jones       colin.jones@york.nhs.uk   
Principal Investigator: Colin Jones         
Doncaster Royal Infirmary Recruiting
Doncaster, United Kingdom, DN2 5LT
Contact: Mohan Arkanath       mohan.arkanath@dbh.nhs.uk   
Principal Investigator: Mohan Arkanath         
Sponsors and Collaborators
University of Leeds
Kidney Research UK
National Health Service, United Kingdom
Baxter Healthcare Corporation
Foundation for Informed Medical Decision Making
X-Lab systems, University of Leeds (www.x-labsystems.co.uk)
Investigators
Principal Investigator: Hilary L Bekker, PhD University of Leeds
  More Information

No publications provided

Responsible Party: Hilary L Bekker, Senior Lecturer in Behavioural Sciences and Chartered Psychologist, University of Leeds
ClinicalTrials.gov Identifier: NCT01671228     History of Changes
Other Study ID Numbers: V4_01_JUN_12, SP2/Choices/2012, 0171-1
Study First Received: August 16, 2012
Last Updated: August 22, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Leeds:
dialysis
chronic kidney failure
informed choice
patient decision making
decision aid

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 20, 2014