Clinical trial NCT02858713: Adherence in Topical Treatment of Psoriasis
Official title: Can an App Supporting Psoriasis Patients Improve Adherence to Topical Treatment? A Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adherence
Keywords: psoriasis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* aged under 18 and above 75 years, guttate psoriasis, severe degree of psoriasis, i.e. pustular and erythrodermic psoriasis, lack of smartphone and user skills for the smartphone

Primary outcomes:
measure: Percentage of Adherent Participants
timeFrame: Week 4
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, week 4, 8 and 26
measure: Lattice-System Physician's Global Assessment (LS-PGA)
timeFrame: Week 4, 8 and 26
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Department of Dermatology and Allergy Centre
Study officials:
affiliation: Department of Dermatology and Allergy Centre, Odense University Hospital
name: Mathias Tiedemann Svendsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Svendsen MT, Andersen F, Andersen KH, Andersen KE. Can an app supporting psoriasis patients improve adherence to topical treatment? A single-blind randomized controlled trial. BMC Dermatol. 2018 Feb 7;18(1):2. doi: 10.1186/s12895-018-0071-3.
citation: Svendsen MT, Andersen F, Andersen KH, Pottegard A, Johannessen H, Moller S, August B, Feldman SR, Andersen KE. A smartphone application supporting patients with psoriasis improves adherence to topical treatment: a randomized controlled trial. Br J Dermatol. 2018 Nov;179(5):1062-1071. doi: 10.1111/bjd.16667. Epub 2018 Jul 5.