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
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 16, 2012 | ||||||||
| Last Updated Date | August 22, 2012 | ||||||||
| Start Date ICMJE | January 2011 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01671228 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE |
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) |
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| Original Other Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Developing and Evaluating the Yorkshire Dialysis Decision Aid | ||||||||
| Official Title ICMJE | Development of a Patient Decision Aid (PtDA) to Facilitate Renal Patients Informed Decisions About Dialysis Treatments | ||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
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| Condition ICMJE | Chronic Kidney Failure | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 560 | ||||||||
| Estimated Completion Date | February 2013 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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 - |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01671228 | ||||||||
| Other Study ID Numbers ICMJE | V4_01_JUN_12, SP2/Choices/2012, 0171-1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Hilary L Bekker, University of Leeds | ||||||||
| Study Sponsor ICMJE | University of Leeds | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Leeds | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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