Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02858713
Other study ID # 2016-002143-42
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 9, 2017
Est. completion date August 29, 2017

Study information

Verified date February 2019
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date August 29, 2017
Est. primary completion date April 29, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Calcipotriene + Betamethasone Dipropionate
Participants received Calcipotriene + Betamethasone Dipropionate once daily when needed for the entire study period.
Device:
App
App named MyPso SmarTopTM Version 1.0 (LEO Pharma) was used for 28 days by participants in the intervention arm.

Locations

Country Name City State
Denmark Department of Dermatology and Allergy Centre Odense C

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View Citation

Svendsen MT, Andersen F, Andersen KH, Pottegård A, Johannessen H, Möller 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 Dermato — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Adherent Participants Rate of adherent patients, defined as dichotomized adherence rates obtained by number of days with applied medication with a selected cut-off of 80%, with adherence rates above 80% considered adherent Week 4
Secondary Dermatology Life Quality Index (DLQI) Change from baseline to week 4
Description of Dermatology Life Quality Index (DLQI): A score from 0-30 [0, patients' quality of life not affected; 30, patients' quality of life severely affected by the skin disease]. The DLQI-scale is a summary of 10 questions on subscales, where patients' report how severely their quality of life has been affected for the last week (patient reported outcome measurements (PROM), each subscale have a score from 0 (not affected by skin disease) to 3 (severely affected by skin disease).
The minimum score is 0 and the highest score is 30, a high score means worse outcome.
Baseline, week 4, 8 and 26
Secondary Lattice-System Physician's Global Assessment (LS-PGA) Change from baseline to week 4, 8 and 26
Lattice System Physican's Gloabal Assessment (LS-PGA) is a measure from 0-8 (0, patients skin clear; 8, patients' skin severely affected by psoriasis). The scale is a summary of three subscales: 1). thickness of psoriasis, 2). extent of scaling and 3). body surface ares (BSA) affected. The minimum score is 0 and the maximum score is 8, a high score represents a worse outcome.
Week 4, 8 and 26
See also
  Status Clinical Trial Phase
Completed NCT02858050 - Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications
Completed NCT01957865 - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda N/A
Completed NCT01696331 - Text Messaging for Adherence in Adolescent Liver Transplant Recipients N/A
Completed NCT02041390 - Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases N/A
Completed NCT00218452 - Smoking Cessation for Young Adults Who Binge Drink - 1 Phase 0
Recruiting NCT06351007 - Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK) N/A
Completed NCT02336334 - Evaluation of Posturing-Adherence in Patients After Intraocular Surgery N/A
Completed NCT02354729 - Encouraging Allergic Young Adults to Carry Epinephrine N/A
Completed NCT02135003 - Non-enrolment and Non-adherence to HIV Care in a Community-based Program, Rakai, Uganda N/A
Recruiting NCT02621008 - Mobile Phone-based Intervention for Promoting Healthy Habits and Weight Loss N/A
Completed NCT01247181 - Cameroon Mobile Phone SMS Trial N/A
Recruiting NCT05369845 - Observance of Continuous Positive Pressure for the Treatment of Obstructive Sleep Apnea Syndrome N/A
Completed NCT02424786 - Non-adherence and Polypharmacy in Elderly Patients N/A
Completed NCT01118767 - Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru N/A
Active, not recruiting NCT03142256 - 3Ps for Prevention Study (Perception, Partners, Pills) Phase 4
Withdrawn NCT02468544 - Development and Feasibility Testing of a Mobile Phone-Based HIV Primary Care Engagement Intervention N/A
Active, not recruiting NCT01509014 - Community Pharmacy Assisting in Total Cardiovascular Health N/A
Recruiting NCT04557293 - Effort-based Decision-making and CPAPadherence N/A
Terminated NCT02822755 - Home Exercise Adherence in Physical Therapy N/A
Completed NCT01120704 - Evaluation of Treatments to Improve Smoking Cessation Medication Adherence Phase 4

External Links