Health LiteracyGoutConnectNCT06971146
Nurse-Led Telehealth for Gout
A study testing Nurse-Led Self-Management Support and GP-follow up in people with Health Literacy and Gout Arthritis, run by University of Aarhus at 5 sites in Denmark.
Trial summary
The aim of this clinical trial is to evaluate whether nurse-led telehealth support helps individuals with gout better manage their condition and adhere to urate-lowering medication after discharge from a rheumatology clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Literacy, Gout Arthritis, Gout Initiating Urate-loweringUrate-lowering Therapy
- What is being tested?
- Nurse-Led Self-Management Support and GP-follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Oct 2025to 1 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Fulfills ACR/EULAR 2015 Gout Classification Criteria
- Estimated Glomerular Filtration Rate (e-GFR) >30 ml/min
- Prescribed Allopurinol or Adenuric, and achieved two consecutive serum urate levels of two consecutive serum urate levels of ≤0.30 mmol/l for patients with tophi and ≤0.36 mmol/L for patients without tophi
- Have sufficient Danish reading and writing skills to understand information and complete questionnaires.
Who cannot join
- Cognitively impaired, unable to understand or provide informed consent.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Annette de Thurah, CNS, MPH, PHD, +4529120722, annethur@rm.dk
Sofie B Vestergaard, RN, MSc, PhD-fellow, +4523425312, sofive@rm.dk
- Recruiting
Gødstrup Hospital
Herning, 7400
Sara Vildhøj, MD, PHD, sara.vild@rm.dk
- Recruiting
Horsens Hospital
Horsens, 8700
Jakob B Andersen, MD, PHD, +4578426961, jakoande@rm.dk
- Recruiting
Randers Hospital
Randers, 8930
Stine G Skov, RN, stinskov@rm.dk
- Recruiting
Silkeborg Hospital
Silkeborg, 8600
Thomas Andersen, MD, PHD, thomas.andersen@midt.rm.dk
About this study
Official title: Health Literacy-Based, Nurse-Led Telehealth Support for Gout Self-Management: the Danish Randomized GOUTCONNECT Trial
The aim of this clinical trial is to evaluate whether nurse-led telehealth support helps individuals with gout better manage their condition and adhere to urate-lowering medication after discharge from a rheumatology clinic.
Eligible patients will be recruited from five rheumatology departments in the Central Denmark Region after achieving two consecutive target serum urate levels-below 0.36 mmol/L, or below 0.30 mmol/L for patients with tophi.
Read more
Participants will be adults with gout who meet specific medical criteria, are taking medications such as allopurinol or Adenuric, and are able to read and write Danish.
Participants will be randomly assigned to one of two groups:
- Intervention group: nurse-led telehealth support.
- Control group: usual care with follow-up by their general practitioner.
The primary goal is to support patients in maintaining healthy uric acid levels after 52 weeks.
Participants in the nurse-led group have the option to choose from four support options:
I1: App-Based Support - an app provides information and reminders. I2: Letter Reminders - messages are sent via digital or postal mail. I3: Text Reminders - SMS messages are sent every three months. I4: Phone Support - nurses call three times a year to check in.
- Conditions
- Health Literacy, Gout Arthritis, Gout Initiating Urate-loweringUrate-lowering Therapy, Telehealth, Digital Health, Adherence
- Being tested
- Nurse-Led Self-Management Support, GP-follow up
- Keywords
- self-managment
- Medical subject headings
- Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Self-Management SupportOther
The intervention offers four distinct support options. Patients are free to choose the option that best suits their preferences and needs.
I1: App-Based Monitoring - Patients receive an app that provides relevant health information, including short educational videos, images, and other resources. Every three months, the app sends a pop-up reminder.
I2: Reminder by Letter - Patients receive a friendly reminder every three months via e-Boks or postal mail (for those without e-Boks access) encouraging continued treatment adherence.
I3: SMS Reminder - Patients receive a text message every three months to remind them to continue their treatment.
I4: Phone Call Check-In - A nurse contacts the patient by phone three times per year at scheduled intervals to provide support and ensure they remain on track with their treatment.
GP-follow upOther
Patients in the control group will be discharged from the hospital and continue with routine care provided by their general practitioner (GP). The GP will receive a discharge letter outlining the recommended treatment plan. In addition, patients will receive a letter containing key information about their condition, along with a recommendation to consult their GP annually for ongoing disease monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led self-management support | Experimental | Not described Receives: Other: Nurse-Led Self-Management Support |
| GP-follow up | Active comparator | Not described Receives: Other: GP-follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving target serum urate (s-urate) concentration
The number and proportion of participants with a serum urate concentration equal to or less than 0.36 mmol/L or 0.30 mmol/L if tophi, at 52 weeks after randomization.
Measured: 52 weeks
Gout impact
Changes in Gout Impact Scale (GIS). GIS is a patient-reported outcome measure assessing the impact of gout on health-related quality of life. The GIS includes domains such as gout concern overall, gout medication side effects, unmet treatment need, well-being during gout attack, and concern during gout attack. Each domain is scored on a 0-100 scale, with higher scores indicating greater impact (worse health status).
Change from baseline to week 52 will be calculated, with negative change scores indicating improvement (i.e., reduced gout impact).
Measured: 52 weeks
Secondary outcomes (2)
Quality of life one year after discharge from a rheumatology clinic indicated by EQ-5D-5L.
The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group, covering five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. An index score will be calculated based on country-specific value sets, with scores typically ranging from <0 (worse than death) to 1 (perfect health). Change from baseline to week 52 will be assessed, with positive changes indicating improvement in health-related quality of life.
Measured: 52 weeks
Proportion of participants adherent to urate lowering drugs based on CQR-5
Adherence to urate lowering drugs will be assessed using the Compliance Questionnaire Rheumatology 5-item version (CQR-5). The CQR-5 is a patient-reported questionnaire specifically developed to measure adherence in patients with rheumatic diseases. Each item is scored on a 4-point Likert scale, and an overall adherence score is calculated. Participants will be classified as adherent if their CQR-5 score is above the predefined threshold for good adherence (e.g., ≥80% predicted probability of adherence based on validated cutoff.)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized controlled superiority trial with two parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg, Gødstrup Hospital, Randers Regional Hospital, Regionshospitalet Horsens
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971146
- Sponsor's protocol ID
- 1-10-72-165-24
- Other IDs
- 2096-00035B
- Acronym
- GoutConnect
- Status last verified
- Sep 2025
- First submitted
- 6 May 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No