Condition category
Urological and Genital Diseases
Date applied
19/04/2015
Date assigned
21/04/2015
Last edited
25/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The importance of involving patients, clinicians and health policy makers in decision-making processes surrounding the focus of scientific research is well known. But not many studies have looked at how the research focus is decided in the chronic kidney disease (CKD) population. The James Lind Alliance (JLA) is a non-profit organisation that brings patients, carers and clinicians together in workshops to discuss what they feel are the top 10 most important unanswered questions about the medical treatments relevant to them. People that attend the JLA workshop create a list of treatment areas they believe should be top priority in scientific research using a method called the nominal group technique (NGT). The NGT is a way of helping groups of people work together to identify a problem, create a solution and decide on the best way to go about it. The downside of the JLA/NGT workshop method is that it involves a lot of resources. It also requires participants to attend a workshop which might not always be convenient. Also, travel may be difficult for patients with chronic illness, and this may affect their ability to participate in such an event. An online wiki-based NGT may be a more cost-effective way of running workshops. A ‘wiki’ is a website that anybody can contribute to, so it may help involve a broader group of participants in online workshops. The aim of this study is to compare how well a new NGT-wiki website helps create a top 10 list of CKD-related research questions compared to the traditional, in-person NGT-workshop approach. The top 10 research priorities lists resulting from each process will be used to see whether the online method works as well as the in-person workshop method.

Who can participate?
Adults who are either CKD patients, CKD-patient caregivers, CKD clinicians or CKD-related health policy makers.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) attend an in-person workshop. Those in group 2 (intervention group) have access to an online wiki-based website.

What are the possible benefits and risks of participating?
There are no risks or benefits to participants.

Where is the study run from?
1. University of Calgary (Canada)
2. The University of British Columbia (Canada)
3. University of Alberta (Canada)
4. University of Manitoba (Canada)
5. University of Toronto (Canada)
6. Memorial University (Canada)
7. University of Western Ontario (Canada)

When is the study starting and how long is it expected to run for?
September 2014 to June 2015

Who is funding the study?
1. The Interdisciplinary Chronic Disease Collaboration (Canada)
2. Canadian Institutes of Health Research (Canada)
3. Alberta Innovates - Health Solutions (Canada)

Who is the main contact?
Dr B Hemmelgarn (Public)
brenda.hemmelgarn@albertahealthservices.ca

Trial website

Contact information

Type

Public

Primary contact

Dr Brenda Hemmelgarn

ORCID ID

http://orcid.org/0000-0001-6818-4385

Contact details

1403 29th St NW
Calgary
T2N 2T9
Canada
+1 (0)403 210 7260
brenda.hemmelgarn@albertahealthservices.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A comparison of an in-person nominal group technique and an online wiki-based nominal group technique in chronic kidney disease research prioritization: a randomized controlled trial

Acronym

Study hypothesis

Among groups of patients with chronic kidney disease (CKD), informal caregivers', policy makers' and clinicians' use of an online wiki-based platform and nominal group technique will achieve similar CKD research priorities to an in-person nominal group technique (reference standard) as determined through comparison of the top 10 ranked research priorities lists resulting from each process.

Ethics approval

Conjoint Health Research Ethics Committee, University of Calgary, 05/03/2015, ref: REB15-0252

Study design

Randomized controlled parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Chronic kidney disease

Intervention

Participants will be randomized into one of two groups:
1. In-person workshop
2. Online Wiki-based platform

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The top 10 CKD-related research uncertainties analyzed by pairwise agreements between the two groups' priorities (provided as ranks).

Secondary outcome measures

1. Perceived engagement of participants in the prioritization process
2. Participant satisfaction with the process
3. Time requirements to complete the prioritization process
4. Costs associated with each process

Overall trial start date

01/09/2014

Overall trial end date

25/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Adults ≥ 18 years that belong to one of the following groups:
1. Patients with CKD (eGFR < 45 mL/min/1.73 m2, not on dialysis or with a prior transplant)
2. Informal caregivers of persons with CKD
3. Clinicians (physicians, nurses, and allied health professionals) who care for patients with CKD
4. Health policy makers (those who determine policies and practices related to health care delivery for CKD)
5. Eligible participants will have high health literacy and access to a computer and internet

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

37 assigned to each intervention.

Participant exclusion criteria

1. Patients with eGFR <15 mL/min/1.73 m2 and/or receiving dialysis
2. Patients who have received a kidney transplant
3. Persons with an underlying diagnosis of dementia or cognitive impairment
4. Patients admitted to hospital or deemed unfit to travel
5. Non-English speaking individuals

Recruitment start date

30/04/2015

Recruitment end date

31/05/2015

Locations

Countries of recruitment

Canada

Trial participating centre

University of Calgary
Calgary
AB T2N 1N4
Canada

Trial participating centre

The University of British Columbia
Vancouver
BC V6T 1Z4
Canada

Trial participating centre

University of Alberta
Edmonton
AB T6G 2R3
Canada

Trial participating centre

University of Manitoba
Winnipeg
MB R3T 2N2
Canada

Trial participating centre

University of Toronto
Toronto
ON M5S
Canada

Trial participating centre

Memorial University
St John's
NL A1B 3X9
Canada

Trial participating centre

University of Western Ontario
London
ON N6A 3K7
Canada

Sponsor information

Organisation

Interdisciplinary Chronic Disease Collaboration

Sponsor details

1403 29th St NW
Calgary
T2N 2T9
Canada
+1 (0)403 210 7065
brenda.hemmelgarn@albertahealthservices.ca

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Interdisciplinary Chronic Disease Collaboration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Funder name

Alberta Innovates - Health Solutions

Alternative name(s)

AIHS

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Canada

Results and Publications

Publication and dissemination plan

We intend to publish the results in a nephrology journal, and aim to have this submitted by fall 2015. We will also present at conferences, including the Canadian Society of Nephrology (spring 2016) and American Society of Nephrology (fall 2016).

Intention to publish date

01/01/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27553026

Publication citations

Additional files

Editorial Notes

25/08/2016: Publication reference added.