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Gout Self-Management App: eHealth Tool for People with Gout

Patient-centred eHealth approach to improving outcomes for gout sufferers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000455460
Acronym
GAPP (Gout App)
Enrollment
537
Registered
2016-04-07
Start date
2018-02-22
Completion date
2020-02-21
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Gout is increasing despite effective therapies to lower serum urate concentrations to 0.36 mmol/L or less, which, if sustained, significantly reduces acute attacks of gout. Adherence to urate lowering therapy (ULT) is poor, with rates of less than 50% one year after initiation of ULT. Attempts to increase adherence in gout patients have been disappointing. Aims: We aim to evaluate the effectiveness of use of a personal, self-management, ‘smartphone’ application (app) to achieve target serum urate concentrations in people with gout. We hypothesise that personalised feedback of serum urate concentrations will improve adherence to ULT. Method: A prospective, cluster randomised controlled trial is conducted in primary care setting. GP practices are randomised to either intervention or control clusters with their patients allocated to the same cluster. The intervention group has access to the Healthy.me app tailored for the self-management of gout. The control group patients have access to the same app modified to remove all functions except the Gout Attack Diary. Outcome measures: Primary outcome is the proportion of patients whose serum urate concentrations are less than or equal to 0.36 mmol/L after 6 months. Secondary outcomes are proportions of patients achieving target urate concentrations at 12 months, ULT adherence rates, serum urate concentrations at 6 and 12 months, rates of attacks of gout, quality of life estimations and process and economic evaluations. The study is designed to detect a =30% improvement in the intervention group above the expected 50% achievement of target serum urate at 6 months in the control group: power 0.80, significance level 0.05, assumed ‘drop-out’ rate 20%. Conclusion: The study is being conducted. Involvement of GPs is essential to the management of people with gout in the community and in the evaluation of usefulness of new technology in primary care.

Interventions

The intervention group will be provided with access to the Healthy.me app tailored for the self-management of gout. Healthy.me is a self-management eHealth app available on smartphones and tablets that contains features to help patients manage their chronic diseases. The app has been tailored to promote effective self-management of gout and long-term adherence to ULT. The app was developed, using dimensions of the Health Belief Model: perceived susceptibility, perceived severity, perceived benef

The intervention group will be provided with access to the Healthy.me app tailored for the self-management of gout. Healthy.me is a self-management eHealth app available on smartphones and tablets that contains features to help patients manage their chronic diseases. The app has been tailored to promote effective self-management of gout and long-term adherence to ULT. The app was developed, using dimensions of the Health Belief Model: perceived susceptibility, perceived severity, perceived benefits and perceived barriers. While education materials from the app raise awareness of consequences of uncontrolled gout, susceptibility to gout attacks when serum urate concentrations are high, and the importance of keeping a low serum urate level, the key feature of the app, “Uric Acid Tracker”, is designed to provide personalised feedback on susceptibility to and severity of gout by presenting individual patients’ serum urate levels and gout attack data on a graph. This personalised feedback will enable the patients to relate their high serum urate levels to the occurrence of gout attacks (perceived susceptibility and severity), and recognise attack-free benefits of ULT adherence behaviour when their serum urate is consistently low. Low medication adherence is a major barrier to keeping gout under control, and thus the app is designed to include educational content and pop-up alerts to remind the patients to take their ULTs. Specifically, the intervention app contains these features: • Uric Acid Tracker: Serum urate results will be recorded and graphed under the ‘Uric Acid Tracker’ function. Patients will be asked to obtain their serum urate results from their GP or pathologist after every test, and promptly enter the results into this feature of the app. Alerts within the app will be triggered if serum urate is not in the target range, recommending that patients discuss their gout management with their GP. The patient’s serum urate concentrations will be represented in a graph over time and in relationship to the target serum urate (which is 0.36 mmol/L or lower). • Gout Facts: Educational materials including written information and a video animation about gout and its management for people with gout will be available via the app. The following topics are covered: what is gout, why take ULT medication, the effects of ULT, what to do in a gout attack, and the importance of ULT adherence. • Electronic Gout Attacks Diary: This feature provides the ability to record gout attacks including pain intensity, location of attack(s) or joint(s) affected, and triggers. The gout attack data that patients enter will be presented in the graph next to serum urate levels. • Schedule: This feature can be used as an alternative to the calendar function of smart devices if patients prefer to use it for management of their gout. Patients can schedule their tasks, such as having blood tests and collecting results, seeing their GP or other members of their care team, and recording gout attacks. • Team: Contact details of GP, pathology service, researchers and others such as rheumatologist, physiotherapist etc. can be listed. • Diet Tips: An evidence-based list of foods that can raise or lower serum urate will be available. Patients in the intervention group will be provided with their personal login details to access and download the Healthy.me gout management app and installation guide. They will have access to a short introduction to the ‘Healthy.me app’ and its features via an email or in paper form. There will be an opportunity for patients to ask researchers any questions via the web-site, email, phone or face to face. Patients will have access to the app for 12 months. Patients’ GPs will also have access to the introductory material about the app, and the content of educational materials in the app.

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Adult (>18 yrs) - Diagnosis of gout by GP (either new or flare up) and have had one or more attacks of acute gout in the last 12 months - Receiving ULT treatment or candidate to start or restart ULT treatment - Regular access to a smartphone device, the Internet and able to download mobile phone applications (apps) - Sufficient English language to complete questionnaires - Provide written informed consent

Exclusion criteria

- Pregnant or intending to become pregnant during the study - Psychological condition (i.e. cognitive decline) that may impede participation in the study - Lack of technological experience so that participation in the study would be difficult

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026