Developing and Evaluating the Yorkshire Dialysis Decision Aid (YoDDA)
This study is currently recruiting participants.
Verified August 2012 by University of Leeds
Sponsor:
University of Leeds
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
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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.
-
Exclusion Criteria: Those not literate in English
-
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 May 19, 2013