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
Study website
Contact information
Type
Public
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Other
Study 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
Primary outcome measure
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 study start date
01/09/2014
Overall study end date
25/06/2015
Reason abandoned (if study stopped)
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(s)
All
Age group
Adult
Lower age limit
18 Years
Sex
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
Study participating centre
University of Calgary
Calgary
AB T2N 1N4
Canada
Study participating centre
The University of British Columbia
Vancouver
BC V6T 1Z4
Canada
Study participating centre
University of Alberta
Edmonton
AB T6G 2R3
Canada
Study participating centre
University of Manitoba
Winnipeg
MB R3T 2N2
Canada
Study participating centre
University of Toronto
Toronto
ON M5S
Canada
Study participating centre
Memorial University
St John's
NL A1B 3X9
Canada
Study 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, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Funder name
Alberta Innovates - Health Solutions
Alternative name(s)
AIHS
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/08/2016 | Yes | No |