Completed

YoDDADevelopment of a Patient Decision Aid (PtDA) to Facilitate Renal Patients Informed Decisions About Dialysis Treatments

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What is being tested

Decision Aid

+ Decision Aid

+ Decision Aid + values task

Other
Who is being recruted

Urogenital Diseases+10

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

Over 18 Years
See all eligibility criteria
How is the trial designed

Phase 1
Interventional
Study Start: January 2011
See protocol details

Summary

Principal SponsorUniversity of Leeds
Last updated: May 1, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01671228
Principal SponsorUniversity of Leeds
Last updated: May 1, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

488 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesKidney Failure, Chronic

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 -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Group IV

No Intervention
The consultations and information usually provided by the predialysis health professionals

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Hull and East Yorkshire Hospital Trust

Hull, United KingdomOpen Hull and East Yorkshire Hospital Trust in Google Maps

Sheffield Northern General Teaching Hospital

Sheffield, United Kingdom

St James University Hospital

Leeds, United Kingdom

Bradford Teaching Hospital

Bradford, United Kingdom
Completed6 Study Centers