Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001052325
Ethics application status
Approved
Date submitted
11/07/2017
Date registered
19/07/2017
Date last updated
4/03/2020
Date data sharing statement initially provided
1/04/2019
Date results information initially provided
4/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile health technology and chronic illness: what predicts user engagement with popular gout apps?
Scientific title
Mobile health technology and chronic illness: what predicts user engagement with popular gout apps?
Secondary ID [1] 292310 0
Nil
Universal Trial Number (UTN)
U1111-1193-3788
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 303851 0
Condition category
Condition code
Musculoskeletal 303214 303214 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 303395 303395 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants who are randomized to the intervention group will be asked to use the "Managing Gout" app for two weeks. The “Managing Gout” app provides information about gout, its causes, identifies common triggers which may cause flares, lifestyle tips for preventing gout flares and treatment options. In addition, this app also includes a series of health trackers such as the serum uric acid tracker and gout flare tracker in which the user can enter their details and track changes across time. Furthermore, this app allows users to enter their doctor appointments, log questions for their healthcare providers, log their medications and supplements used to manage gout and other conditions and also links them to helpful online resources. Participants who are allocated to use this app can use whatever functions they find to be helpful and will be encouraged to use the app on a daily basis. They will also be sent two text message reminders (two times during the 2-week trial period) to remind them to use the app on a daily basis.
Intervention code [1] 298483 0
Behaviour
Comparator / control treatment
The active control group will be the participants who are assigned to receive the "DASH Diet Plan" app. This app provides information about the DASH (Dietary Approaches to Stop Hypertension) diet eating plan which has been shown to be effective in managing various health conditions such as gout. The app educates users about the DASH diet, provides information to allow users to create a diet action plan and informs users what foods are beneficial and which should be avoided. This app also provides various recipes and meal ideas for breakfast, lunch, dinner, dessert and snacks. They will also receive the same text message reminders as the intervention group (two times during the two week period).
Control group
Active

Outcomes
Primary outcome [1] 302589 0
User engagement; examined by using a modified version of the Mobile Application Rating Scale (MARS) (Stoyanov, Hides, Kavanagh, Zelenko, Tjondronegoro & Mani, 2015)
Timepoint [1] 302589 0
Upon completion of the 2-week intervention
Primary outcome [2] 302783 0
Usability and acceptability of the apps will also be examined qualitatively by asking a subset of participants (n=10 from each group) to attend an interview and/or focus group about their experience using the apps.
Timepoint [2] 302783 0
Upon completion of the 2-week intervention
Secondary outcome [1] 336453 0
Illness perceptions: Illness perceptions will be measured using a gout-specific Brief Illness Perceptions Questionnaire (Brief IPQ). The B-IPQ has satisfactory reliability and validity across a range of chronic illnesses (Broadbent, Petrie, Main, & Weinman, 2006).
Timepoint [1] 336453 0
Baseline and at completion of the 2-week intervention
Secondary outcome [2] 336707 0
Gout self-care activities: Adherence and self-care activities will be assessed with a self-report questionnaire which covers exercise, medication and diet-related activities over the past seven days. These items were adapted from a diabetes-specific Multidimensional Diabetes Questionnaire (Talbot, Nouwen, Gingras, Gosselin, & Audet, 1997) and have been used previously to assess self-care behaviours in gout (Dalbeth et al., 2012). This is a composite secondary outcome.
Timepoint [2] 336707 0
Baseline and at completion of the 2-week intervention

Eligibility
Key inclusion criteria
Individuals will be eligible for inclusion in the intervention if they meet the following criteria: (1) a diagnosis of gout as defined by the 2015 ACR-EULAR Gout Classification Criteria, (2) a current prescription for urate lowering therapy, (3) > 18 years old, (4) ability to complete forms in English and provide informed consent, (5) own or have access to an iOS smartphone device capable of downloading apps.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An independent samples t-test will be used to asses differences in user engagement between the two app groups. Means, standard deviations and confidence intervals will be presented with the analyses.

Pearsons correlations will be used to explore the relationship between user engagement, secondary outcome measures, demographic characteristics, disease characteristics, and current treatments. Multiple linear regression will also be used to examine which of the variables predict higher user engagement. Content analysis will be used to analyse the focus groups and interviews.

Data analysis will be performed by SPSS

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/08/2017
Actual
24/08/2017
Date of last participant enrolment
Anticipated
Actual
5/05/2018
Date of last data collection
Anticipated
Actual
5/08/2018
Sample size
Target
72
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 9026 0
New Zealand
State/province [1] 9026 0
Auckland

Funding & Sponsors
Funding source category [1] 296851 0
University
Name [1] 296851 0
The University of Auckland
Country [1] 296851 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Dept. of Psychological Medicine
University of Auckland
Private bag 92019, Victoria Street West,
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 295863 0
None
Name [1] 295863 0
Address [1] 295863 0
Country [1] 295863 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298080 0
Health and Disability Ethics Committees
Ethics committee address [1] 298080 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 298080 0
New Zealand
Date submitted for ethics approval [1] 298080 0
23/02/2017
Approval date [1] 298080 0
06/04/2017
Ethics approval number [1] 298080 0
17/NTA/38

Summary
Brief summary
The aim of this study is to test user engagement of two commercially available gout apps and to examine the usability and acceptability of the apps for patients diagnosed with gout. As secondary outcomes, we are also assessing change in self-care behaviours and illness perceptions.

Participants will be recruited through existing projects and studies already running at the School of Medicine, as well as through community advertising. The study will be conducted jointly in the Department of Psychological Medicine and the Department of Medicine, at the University of Auckland.

Participants will trial the app for two weeks after which they will be asked to attend a focus group to examine the issues of usability and acceptability.
Trial website
Trial related presentations / publications
Serlachius, A., Schache, K., Kieser, A., Arroll, B., Petrie, K.J., & Dalbeth, N. (2019). Association between user engagement of a mobile health app for gout and improvements in self-care behaviours: A randomized controlled trial. JMIR mHealth and uHealth,7(8):e15021, doi: 10.2196/15021.
Public notes

Contacts
Principal investigator
Name 75926 0
Dr Anna Serlachius
Address 75926 0
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 75926 0
New Zealand
Phone 75926 0
+64 09 9233073
Fax 75926 0
Email 75926 0
a.serlachius@auckland.ac.nz
Contact person for public queries
Name 75927 0
Anna Serlachius
Address 75927 0
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 75927 0
New Zealand
Phone 75927 0
+64 09 9233073
Fax 75927 0
Email 75927 0
a.serlachius@auckland.ac.nz
Contact person for scientific queries
Name 75928 0
Anna Serlachius
Address 75928 0
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 75928 0
New Zealand
Phone 75928 0
+64 09 9233073
Fax 75928 0
Email 75928 0
a.serlachius@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will only be available if participant identity and data remains anonymous in accordance with the ethical approval/consent process.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Serlachius, A., Schache, K., Kieser, A., Arroll, B... [More Details] 373217-(Uploaded-03-03-2020-15-21-07)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssociation Between User Engagement of a Mobile Health App for Gout and Improvements in Self-Care Behaviors: Randomized Controlled Trial.2019https://dx.doi.org/10.2196/15021
N.B. These documents automatically identified may not have been verified by the study sponsor.