Developing and Evaluating the Yorkshire Dialysis Decision Aid

NCT ID: NCT01671228

Last Updated: 2014-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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decision aid

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

Group Type EXPERIMENTAL

Decision Aid

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Decision Aid

Intervention Type OTHER

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

Decision Aid + values task

Intervention Type 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)

Decision Aid + patient stories

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

Group Type EXPERIMENTAL

Decision Aid

Intervention Type OTHER

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

Decision aid + patient stories

Intervention Type 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

usual predialysis education

The consultations and information usually provided by the predialysis health professionals

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Decision Aid

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

Intervention Type 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

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kidney Cancer UK

OTHER

Sponsor Role collaborator

National Health Service, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Foundation for Informed Medical Decision Making

OTHER

Sponsor Role collaborator

University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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Hilary L Bekker

Senior Lecturer in Behavioural Sciences and Chartered Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilary L Bekker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

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Hull and East Yorkshire Hospital Trust

Hull, East Yorkshire, United Kingdom

Site Status

Sheffield Northern General Teaching Hospital

Sheffield, South Yorkshire, United Kingdom

Site Status

St James University Hospital

Leeds, West Yorkshire, United Kingdom

Site Status

Bradford Teaching Hospital

Bradford, Yorkshire, United Kingdom

Site Status

York teaching Hospital NHS Foundation trust

York, Yorkshire, United Kingdom

Site Status

Doncaster Royal Infirmary

Doncaster, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SP2/Choices/2012

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0171-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

V4_01_JUN_12

Identifier Type: -

Identifier Source: org_study_id

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