Advertisement

Topics

Adherence in Topical Treatment of Psoriasis

2016-08-09 08:53:21 | BioPortfolio

Summary

Medical adherence to topical corticosteroid products in psoriasis patients is a main determinant for poor treatment effect.

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).

Description

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Conditions

Adherence

Intervention

App with electronic monitor

Location

Department of Dermatology and Allergy Centre
Odense C
Denmark
5000

Status

Not yet recruiting

Source

Odense University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-09T08:53:21-0400

Clinical Trials [967 Associated Clinical Trials listed on BioPortfolio]

Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics

Electronic dispensers for polypharmacy are used in home care to assist patients with their medication management and to improve adherence. Opioid dependent patients with substitution thera...

Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use

The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows: 1. To determine whether the use o...

Tel-Me-Box: Validating and Testing a Novel, Low-cost, Real-time Monitoring Device With Hair Level Analysis Among Adherence-challenged Patients

Currently available methods to monitor antiretroviral (ARV) adherence to HIV treatment and prevention, such as self-report, pill counts, medication electronic monitoring system (MEMS), and...

Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control

An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment

This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance S...

PubMed Articles [4515 Associated PubMed Articles listed on BioPortfolio]

The relative benefits of claims and electronic health record data for predicting medication adherence trajectory.

Healthcare providers are increasingly encouraged to improve their patients' adherence to chronic disease medications. Prediction of adherence can identify patients in need of intervention, but most pr...

Comparison of Pharmacy Claims and Electronic Pill Bottles for Measurement of Medication Adherence Among Myocardial Infarction Patients.

Medication adherence after myocardial infarction remains low. Pharmacy claims have typically been used to measure medication adherence, but electronic pill bottles may offer additional information.

Optimizing adherence in HIV prevention product trials: Development and psychometric evaluation of simple tools for screening and adherence counseling.

Low adherence in recent HIV prevention clinical trials highlights the need to better understand, measure, and support product use within clinical trials. Conventional self-reported adherence instrumen...

Medication monitoring attitudes and perceived determinants to offering medication adherence advice to older hypertensive adults: a factorial survey of community pharmacy interns.

Community pharmacy is an ideal setting to monitor medication adherence, however, barriers to pharmacist-led interventions exist. Preparing future pharmacists for enhanced roles may overcome such barri...

Patterns of Oral PrEP Adherence and HIV Risk Among Eastern African Women in HIV Serodiscordant Partnerships.

Understanding how women use PrEP is important for developing successful implementation programs. We hypothesized there are distinct patterns of adherence, related to HIV risk and other factors. We ide...

Medical and Biotech [MESH] Definitions

Extent to which the patient follows prescribed treatment such as keeping APPOINTMENTS AND SCHEDULES and MEDICATION ADHERENCE for desired therapeutic outcome. It implies active responsibility shared by patient and health care providers.

Electronic implements worn on the body as an implant or as an accessory. Examples include wearable diagnostic devices, wearable ACTIVITY TRACKERS, wearable INFUSION PUMPS, wearable computing devices, SENSORY AIDS, and electronic pest repellents.

Electronic devices that increase the magnitude of a signal's power level or current.

Discarded electronic devices containing valuable and sometimes hazardous materials such as LEAD, NICKEL, CADMIUM, and MERCURY. (from http://www.epa.gov/osw/conserve/materials/ecycling/faq.htm#impact accessed 4/25/2010)

Electronic devices that are designed to provide NICOTINE in the form of an inhaled aerosol. They typically are made in the shape of CIGARETTES in order to simulate the experience of CIGARETTE SMOKING.

More From BioPortfolio on "Adherence in Topical Treatment of Psoriasis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Alzumab (Itolizumab)
Biocon Launches ALZUMAb™ - a ‘First in Class’ Novel Biologic Treatment for Psoriasis Patients in India • ALZUMAb™-World's first novel anti-CD6 antibody developed by Biocon to address a large unmet need for th...


Searches Linking to this Trial