NCT01671228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

3.2 years

First QC Date

August 16, 2012

Last Update Submit

April 30, 2014

Conditions

Chronic Kidney Failure

Keywords

dialysischronic kidney failureinformed choicepatient decision makingdecision aid

Outcome Measures

Primary Outcomes (1)

  • Preparation for decision making scale

    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

    one and six weeks after provision information about dialysis choices

Secondary Outcomes (1)

  • Usefulness of information

    one and six weeks after the provision of information

Other Outcomes (1)

  • Dialysis treatment preferences

    one week and six weeks after the information

Study Arms (4)

decision aid

EXPERIMENTAL

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

Other: Decision Aid

Decision Aid + values task

EXPERIMENTAL

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 AidOther: Decision Aid + values task

Decision Aid + patient stories

EXPERIMENTAL

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

Other: Decision AidOther: Decision aid + patient stories

usual predialysis education

NO INTERVENTION

The consultations and information usually provided by the predialysis health professionals

Interventions

Decision AidOTHER

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

Decision Aid + patient storiesDecision Aid + values taskdecision aid
Decision aid + patient storiesOTHER

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

Decision Aid + patient stories
Decision Aid + values taskOTHER

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 + values task

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hull and East Yorkshire Hospital Trust

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Sheffield Northern General Teaching Hospital

Sheffield, South Yorkshire, S57AU, United Kingdom

Location

St James University Hospital

Leeds, West Yorkshire, LS97TF, United Kingdom

Location

Bradford Teaching Hospital

Bradford, Yorkshire, BD5 0NA, United Kingdom

Location

York teaching Hospital NHS Foundation trust

York, Yorkshire, YO31 8HE, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, DN2 5LT, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Hilary L Bekker, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Behavioural Sciences and Chartered Psychologist

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 23, 2012

Study Start

January 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 1, 2014

Record last verified: 2014-04

Locations

GB(6)