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We aim to test if a multifaceted intervention delivered in an app for smartphones combined with an Electronic Monitor (EM) can improve medical adherence among psoriasis patients treated with a topical calcipotriol/betamethasone dipropionate foam combination (Cal/BD).
Material and methods Intervention: Participants in the intervention group download a patient supporting app which combined with an EM has three functions: 1) Measures use of medication through EM, 2) measures degree of psoriasis by photos taking by patients and symptomatology tracking by patients and 3) supports the patient with treatment and refill reminders and through education and motivation on daily care routine.
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 18-60 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 adherence, we wish to detect a 40 % difference between intervention and control in use of Cal/BD over a 4 week treatment period. Confidence Interval (two-sided) using 95 % C.I., power 80, ratio of sample size 1, mean use in control group 30 g/week, S.D. 23 g/week, drop-outs 10 %:
Total sample size: 128 All participants will be seen by trial investigator at all of the study visits. Disclosure and informed signed consent: The patients are not aware they are in a trial and being monitored before last study visit week 26, where full disclosure is given and a signed approval to participate in the trial is obtained. If participants do not sign informed consent they are excluded from the study and their data deleted.
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 topical corticosteroids for 4 weeks based on involved Body Surface Area (BSA).
For randomization we use blocks based on 1) age, 2) gender and 3) BSA. 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 receives the Cal/BD product 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 in a trial and being monitored and only see the patients one time, at the baseline visit. At the baseline visit the nurse delivers free study medication to all participants.
Baseline: Medical history, socio-economic data, DLQI (Dermatology Life Quality Index) and LS-GPA (Lattice System Global Psoriasis Assessment).
Primary outcome measure week 4: Rate of secondary nonadherence to Cal/BD product is calculated by the proportion Estimated use 0.5 g/% Body Surface Area (BSA) involved / use of topical product in a 4-week treatment period (measured by EM) Secondary outcome measures week 8 and 26: DLQI and LS-GPA, see fig. 1. At study visit week 8 the patients return the EM to the investigator.
Results: Only data obtained from the participants who gave a signed consent at last study visit week 26 will be analyzed.
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 our knowledge, this is the first study in psoriasis, testing if an intervention delivered by apps can improve medical adherence.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
App with electronic monitor
Department of Dermatology and Allergy Centre
Not yet recruiting
Odense University Hospital
Published on BioPortfolio: 2016-08-09T08:53:21-0400
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