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Treat-to-target by Email During Urate-lowering Therapy in Gout (GOUTEmail)

Primary Purpose

Gout, Inflammatory Rheumatism, Hyperuricemia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cleanweb electronic messaging ePro
Usual follow-up
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring Treat-to-target, Gout, Tophus, Urate crystals, Urate-lowering therapy, Febuxostat, Allopurinol, Therapeutic strategy, Electronic messaging, Therapeutic compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults aged over 18 years old
  • Gout confirmed by identification of urate crystals by joint fluid or tophus analysis or by ultrasound of the affected joint or
  • Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on the following items:

Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL > 360 μmol/l during the crisis (3.5 pts)

  • Patients without ULT or with an ineffective ULT defined by an SUL > 360 μmol/l in intercritical pahse
  • Patients who routinely use e-mail

Exclusion Criteria:

  • Participating in another trial including the administration of a drug
  • Patients treated with azathioprine
  • Patients intolerant to hypouricemic treatments
  • Unable to use the internet
  • Difficulty understanding French
  • Illiteracy
  • Pregnant womenor breastfeeding mothers (see PHC article L.1121-5)
  • Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a health or social institution for purposes other than research (see CSP Article L.1121-6)
  • Major persons subject to a measure of legal protection or unseeding to express consent (see PHC Article L.1121-8)
  • Persons not affiliated to a social security plan or beneficiaries of such a plan (see PHC Article L.1121-8-1)

Sites / Locations

  • Rhumathology departmentRecruiting
  • Hopital LARIBOISIERE - RhumatologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

E-mail follow-up group

Usual follow-up group

Arm Description

Email-led treat-to-target strategy with regular adaptation of ULT via electronic messaging

Adaptation and follow-up of ULT according to referring physician's habits

Outcomes

Primary Outcome Measures

Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout)

Secondary Outcome Measures

Average dose of ULT (allopurinol and febuxostat)

Full Information

First Posted
January 24, 2021
Last Updated
August 29, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04733079
Brief Title
Treat-to-target by Email During Urate-lowering Therapy in Gout
Acronym
GOUTEmail
Official Title
Treat-to-target by Email During Urate-lowering Therapy in Gout
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Gout is secondary to urate crystal deposition after chronic elevation of serum urate level (SUL). Long-term lowering SUL below 360 µmol/L allows dissolution of deposited crystals and disease cure. There is currently a paradoxical observation: while urate-lowering therapy (ULT) is available and efficient there is an increase of gout prevalence and severity. The apparent failure of ULT in gout management is due to several causes including unadjusted dosage, no SUL verification, irregular follow-up and low treatment compliance. In contrast, a nurse-led treat-to-target (T2T) strategy with regular adaptations of ULT until reaching SUL target allows gout cure in more than 90% of patients. We hypothesize that an electronic messaging-led T2T strategy will allow obtaining similar results. The aim of this study is to demonstrate that email-led T2T strategy during ULT is superior to usual care.
Detailed Description
The study will include 204 gouty patients without ULT or with ineffective ULT. This is a multicenter and randomized study (e-mail follow-up vs usual follow-up groups). This study will include the following visits: Selection/inclusion visit (V0): If available biological data (leucocyte count, hemoglobin level, creatininemia and estimated glomerular filtration rate (eGFR), SUL) were assessed during the last month, , included patient will be randomized at the end of the consultation to follow either an email-led T2T strategy or usual ULT care. In the absence of biological results, the patient will be reviewed within the month with blood analysis and then randomized. Follow-up visits: consultations will be carried out according to the usual care of the referring physician. Visit M12 end of research: clinical evaluation of gout, demographic characteristics, medication, type and dose of ULT, blood analysis (serum creatinine level, eGFR, SUL). The study ends after the M12 consultation. The total duration of participation in the study is 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Inflammatory Rheumatism, Hyperuricemia, Posology Adjustment
Keywords
Treat-to-target, Gout, Tophus, Urate crystals, Urate-lowering therapy, Febuxostat, Allopurinol, Therapeutic strategy, Electronic messaging, Therapeutic compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-mail follow-up group
Arm Type
Experimental
Arm Description
Email-led treat-to-target strategy with regular adaptation of ULT via electronic messaging
Arm Title
Usual follow-up group
Arm Type
Active Comparator
Arm Description
Adaptation and follow-up of ULT according to referring physician's habits
Intervention Type
Other
Intervention Name(s)
Cleanweb electronic messaging ePro
Intervention Description
Patient and their medecin will communicate regulary via Cleanweb electronic messaging ePro to adapt the posology of THU untill the target urecemia is reached
Intervention Type
Other
Intervention Name(s)
Usual follow-up
Intervention Description
Adaptation and follow-up of ULT according to referring physician's habits
Primary Outcome Measure Information:
Title
Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout)
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Average dose of ULT (allopurinol and febuxostat)
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged over 18 years old Gout confirmed by identification of urate crystals by joint fluid or tophus analysis or by ultrasound of the affected joint or Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on the following items: Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL > 360 μmol/l during the crisis (3.5 pts) Patients without ULT or with an ineffective ULT defined by an SUL > 360 μmol/l in intercritical pahse Patients who routinely use e-mail Exclusion Criteria: Participating in another trial including the administration of a drug Patients treated with azathioprine Patients intolerant to hypouricemic treatments Unable to use the internet Difficulty understanding French Illiteracy Pregnant womenor breastfeeding mothers (see PHC article L.1121-5) Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a health or social institution for purposes other than research (see CSP Article L.1121-6) Major persons subject to a measure of legal protection or unseeding to express consent (see PHC Article L.1121-8) Persons not affiliated to a social security plan or beneficiaries of such a plan (see PHC Article L.1121-8-1)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Korng EA, PH-PU
Phone
1 49 95 88 25
Ext
+33
Email
hang-korng.ea@aphp.fr
Facility Information:
Facility Name
Rhumathology department
City
Paris
State/Province
Ile-De-France
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hang-Korng Pr EA, PHPU
Facility Name
Hopital LARIBOISIERE - Rhumatologie
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johann BEAUDREUIL, PUPH
Phone
01 49 95 88 28
Email
johann.beaudreuil@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treat-to-target by Email During Urate-lowering Therapy in Gout

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