Adherence in Topical Treatment of Psoriasis
Condition: Adherence
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Medical adherence to topical corticosteroid products in psoriasis patients is a main
      determinant for poor treatment effect.

      The investigators aim to test if a multifaceted intervention delivered in an app (MyPso
      QualityCareTM owned by Leo Pharma) for smartphones combined with an Electronic Monitor (EM)
      (Teslo) can improve medical adherence among psoriasis patients treated with a topical
      calcipotriol/betamethasone dipropionate foam combination (Cal/BD) (Enstilar©).

      The study is classified as a phase 4 study, since it is studied if improved use of Enstilar©
      results in improved treatment outcomes.

      Link to published study protocol:

      https://bmcdermatol.biomedcentral.com/articles/10.1186/s12895-018-0071-3

      Link to published results from the study:

      https://onlinelibrary.wiley.com/doi/abs/10.1111/bjd.16667
    

Detailed description: 
      Material and methods Intervention: Participants in the intervention group download a patient
      supporting app (MyPso SmarTop™ Version 1.0, owned by Leo Pharma) which combined with an EM
      (SmarTop™ number 053776, owned by Leo Pharma) has three functions: 1) Measures use of
      medication through EM, 2) measures degree of psoriasis by patients tracking symptoms, and 3)
      supports the patient with treatment and refill reminders.

      Study type: Single-blind block randomized controlled trial. Sampling: Patients are sampled
      from the dermatology out-patient clinic at Odense University Hospital.

      Eligibility criteria: Psoriasis patients aged 18-75 years with mild-moderate psoriasis. It is
      mandatory that patients have a smartphone and basic skills for use of the smartphone.

      Estimated sample size: To be able to improve medical adherence, the investigators wish to
      detect an 8 % difference between number of applications between intervention and control arm
      in use of Enstilar© over a 4 week treatment period. Confidence Interval (two-sided) using 95
      % C.I., power 80, ratio of sample size 1, mean number of application in intervention Group 90
      % of recommended daily application / 4 weeks, S.D. 15 %, drop-outs maximum 10 %:

      Total sample size: 134 participants All participants will be seen by trial principal
      investigator at all of the study visits.

      Disclosure and informed signed consent will be obtained before inclusion: The patients are
      aware they test new equipments, but not informed that they are being monitored or the purpose
      of the study.

      Randomization: Single-blind block randomized controlled trial. Procedure: At the first study
      visit the trial investigator obtains information regarding gender, age and estimates use of
      Enstilar© for 4 weeks based on involved Body Surface Area (BSA).

      For randomization the investigators use blocks based on 1) age and 2) gender.

      Procedures at baseline study visit: While the patient fills the Dermatology Life Quality
      Index (DLQI) questionnaire, the trial investigator inserts baseline data into the programme
      REsearch Data Capture (REDCap©) randomize, which randomizes into an intervention- and control
      arm. Both intervention- and control group receive Enstilar© in the consultation.

      To avoid attrition bias from the prescribing doctor, knowledge regarding which patients that
      are randomized for the intervention is restricted to one nurse until last study visit. After
      the consultation the patient is referred to a nearby room, where the nurse has access to see
      into which group the participant has been randomized. If the participant is randomized to the
      app group, the nurse will instruct the patient in how to download the app on their smartphone
      and give standard of care instructions regarding how to adhere to the treatment plan. The
      participants in the control group will reveive standard of care instructions from the nurse
      regarding how to adhere to the treatment plan. The nurse will not disclose that the patient
      is being monitored. At the baseline visit the nurse delivers free study medication
      (Enstilar©) to all participants.

      Baseline: Medical history, socio-economic data, DLQI (Dermatology Life Quality Index) and
      LS-PGA (Lattice System Physician's Global Assessment).

      Primary outcome measure week 4: Rate of secondary nonadherence to Enstilar© is obtained using
      three different Measurements:

      Estimated use 0.5 g Enstilar© / % Body Surface Area (BSA) involved / use of Enstilar© in a
      4-week treatment period (measured by weight of Enstilar© cans)

      Number of estimated applications in the treatment period / Number of Applied applications in
      the treatment period (measured by EM)

      Reported by the patient on an interval scale

      Secondary outcome measures week 4, 8, and 26: DLQI and LS-PGA. At study visit week 4 the
      patients return the EM to the investigator.

      Conclusion: If the app for smartphones with the EM can improve adherence and significantly
      improve secondary outcome measures long-term (week 26), there are promising potentials for
      implementing the app in the clinic. To the investigators knowledge, this is the first study
      in topically treated psoriasis, testing if an intervention delivered by in app for
      smartphones can improve medical adherence.
    

Intervention name(s): Calcipotriene + Betamethasone Dipropionate; App
Intervention type(s): Drug; Device
Intervention description(s): Participants received Calcipotriene + Betamethasone Dipropionate once daily when needed for the entire study period.; App named MyPso SmarTopTM Version 1.0 (LEO Pharma) was used for 28 days by participants in the intervention arm.
Other intervention name(s): Enstilar; Mypso app
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: psoriasis