Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000113550
Ethics application status
Approved
Date submitted
26/01/2015
Date registered
9/02/2015
Date last updated
7/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Gout Education: A Study of the Patient Experience
Scientific title
Gout Patients' Experiences with Patient Education Resources: A Qualitative, Focus Group Study
Secondary ID [1] 286040 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 294017 0
Condition category
Condition code
Inflammatory and Immune System 294317 294317 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This research aims to identify the educational needs of New Zealanders suffering from gout, with particular attention paid to the unique needs of different social groups. We aim to determine ways that patient education can be encompassed in a package of care for gout patients. Focus groups with gout patients will be used to explore patients' experiences and perceptions of current care, and to explore new methods for encouraging patients to take their prescribed medications and make the lifestyle and dietary changes necessary for preventing gout attacks and reducing the risk of comorbidities. Patients who consent to participate will complete a questionnaire assessment of their gout history and treatment and will participate in a one-off focus group session lasting 2-3 hours. Health information for each patient will also be obtained through a brief GP questionnaire. Following study completion, this data will be used to develop educational resources within a package of care that is based upon health psychology models of behaviour to effectively encourage behaviour change. Particular focus will be given to the unique needs of different sociocultural groups, with the understanding that a “one size fits all” initiative may not be suitable for the diverse population of gout sufferers. Participants in the study will be Maori and non-Maori, as well as from urban and rural areas of New Zealand. It is anticipated that any resources developed for gout patients will need to be individually tailored for these diverse sociocultural groups. This research will provide the groundwork for improving health outcomes for people with gout, while also demonstrating the importance of taking a patient-centred approach and individualizing patient care initiatives based on social and cultural differences. The results of this research are expected to advance our understanding of the patient experience of gout as well as the strategies that will be most successful in improving their health outcomes.
Intervention code [1] 291026 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294116 0
The primary outcome will be qualitative data describing the patient perspective on gout education and care. Patient perceptions will be assessed through the focus group sessions: all statements that participants write or verbalize (transcribed by the researcher) will be included in the analysis. The primary outcome will be the themes or common ideas that are present within the aggregate data. Too often resources and educational materials come from the health care provider perspective and we aim to contribute the gout patient perspective to shed light on how gout care can be improved. The results will provide the groundwork needed to later develop gout education materials and eventually a gout package of care.
Timepoint [1] 294116 0
There will only be one study timepoint. Patients will participate in a one-off study session.
Secondary outcome [1] 312530 0
Our secondary outcome will be an understanding of the unique educational needs of gout patients from different sociocultural groups, such as Maori vs non-Maori and urban vs. rural. The demographic variables will be assessed through questionnaire measures and the importance of different themes related to gout education will be measured by participants' rankings of these ideas in the focus group sessions.
Timepoint [1] 312530 0
There is only one study timepoint which is the one-off focus group session.

Eligibility
Key inclusion criteria
Diagnosis of gout; lives in Christchurch or Wairoa; NZ European or NZ Maori; able to attend a focus group session
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The only exclusion criteria is patients who are unable to give consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data saturation (no new themes identified) is achieved at relatively low sample size levels (minimum 15) and it is generally thought no more than 60 participants is required (Charmaz, 2006; Creswell, 1998). We will use 60 participants due to our use of 2 settings (30 participants per setting). All ideas generated at all stages of the focus groups (silent generation through group discussion) will be gathered. The data will thus consist of all written statements by patients (in silent generation) and by the researcher (during sharing of ideas and group discussion). The entire session will be audio-recorded and transcriptions of these sessions will be used if necessary (if the researcher is unable to record all ideas at the time of the session). Data analysis will be assisted by the NVivo software program. Inductive thematic analysis will be used to explore the research questions. This process involves extensive familiarization with the data, followed by the generation of initial codes and eventual grouping into overarching themes. Themes will be explored in relation to the 6 aspects of gout care: education, weight management, diet, footwear, co-morbidities, and medication. Additionally, patients will rank the ideas that come out of the discussion by identifying the 5 statements they agree with most. Analyses of variance (ANOVAs) will then be used to identify any differences between subgroups in the importance of the issues raised. The subgroups we will explore are: Maori vs. non-Maori, urban vs. rural, young vs. old (based on mean split of sample), male vs. female, and short vs. long duration of illness (based on mean split of sample).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/02/2015
Actual
11/08/2015
Date of last participant enrolment
Anticipated
31/08/2016
Actual
4/05/2016
Date of last data collection
Anticipated
Actual
4/05/2016
Sample size
Target
60
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 6609 0
New Zealand
State/province [1] 6609 0
Canterbury

Funding & Sponsors
Funding source category [1] 290626 0
University
Name [1] 290626 0
University of Otago
Country [1] 290626 0
New Zealand
Primary sponsor type
Individual
Name
Prof Lisa Stamp
Address
PO Box 4345
Christchurch 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 289317 0
None
Name [1] 289317 0
Address [1] 289317 0
Country [1] 289317 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292258 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 292258 0
Ethics committee country [1] 292258 0
New Zealand
Date submitted for ethics approval [1] 292258 0
26/01/2015
Approval date [1] 292258 0
03/02/2015
Ethics approval number [1] 292258 0
15/STH/9

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54366 0
Prof Lisa Stamp
Address 54366 0
University of Otago Christchurch
Department of Medicine
PO Box 4345
Christchurch 8140
Country 54366 0
New Zealand
Phone 54366 0
+64 03 3640253
Fax 54366 0
Email 54366 0
[email protected]
Contact person for public queries
Name 54367 0
Megan Johnston
Address 54367 0
Christchurch School of Medicine
Ground Floor, Parkside
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 54367 0
New Zealand
Phone 54367 0
+64 03 3786487
Fax 54367 0
Email 54367 0
[email protected]
Contact person for scientific queries
Name 54368 0
Megan Johnston
Address 54368 0
Christchurch School of Medicine
Ground Floor, Parkside
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 54368 0
New Zealand
Phone 54368 0
+64 03 3786487
Fax 54368 0
Email 54368 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.