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Can an app supporting psoriasis patients improve adherence to topical treatment? A single-blind randomized controlled trial.

ABSTRACT: BACKGROUND:Topical corticosteroid or corticosteroid/calcipotriol preparations are recommended first-line topical treatments of psoriasis, but a main cause for the lack of efficacy of topical treatments is considered low rates of adherence to topical drugs. Patient support by the use of applications (apps) for smartphones is suggested to improve medical adherence. METHODS/DESIGN:Design: An investigator-initiated, single-center, single-blind, parallel-group, phase-4 clinical superiority randomized controlled trial (RCT). PARTICIPANTS:134 patients 18 to 75 years of age with mild-to-moderate psoriasis, who are capable of reading English language, own a smartphone, and are candidates for the study drug calcipotriol and betamethasone dipropionate (Cal/BD) cutaneous foam once daily prn (pro re nata). INTERVENTION:A 28-day adherence-supporting app providing compulsory daily treatment reminders that pop-up on the smartphone screen with a short alert sound. The app synchronizes through Bluetooth® to an electronic monitor (EM) attached to the medication canister. The EM contains a chip registering the amount of foam, day and time the patient use the foam dispenser. The information is displayed in a diary that shows the amount of Cal/BD cutaneous foam used and the number of applied treatment sessions. The app has an optional diary with the patient's rating of symptoms. Non-intervention: Use of Cal/BD cutaneous foam and EM without the app. All participants are prescribed Cal/BD cutaneous foam prn for the entire study period. Primary outcome obtained in week 4: rates of adherence measured by patient report, weight of medication canisters, and number of treatment sessions measured by the EM. Secondary outcomes obtained at baseline, weeks 4, 8, and 26: Lattice System Physician's Global Assessment (LS-PGA) and Dermatology Quality of Life Index (DLQI). DISCUSSION:This trial tests of whether an app can improve rates of adherence to a topical antipsoriatic drug. If the app improves rates of adherence and reduces the burden of psoriasis in a clinically significant way, the app could easily be implemented as a standard routine of care in the clinic. TRIAL REGISTRATION:NCT02858713 , registered on August 3, 2016. EudraCT number 2016-002143-42.

SUBMITTER: Svendsen MT

PROVIDER: S-EPMC5804085 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Can an app supporting psoriasis patients improve adherence to topical treatment? A single-blind randomized controlled trial.

Svendsen Mathias Tiedemann MT Andersen Flemming F Andersen Kirsten Hammond KH Andersen Klaus Ejner KE

BMC dermatology 20180207 1

<h4>Background</h4>Topical corticosteroid or corticosteroid/calcipotriol preparations are recommended first-line topical treatments of psoriasis, but a main cause for the lack of efficacy of topical treatments is considered low rates of adherence to topical drugs. Patient support by the use of applications (apps) for smartphones is suggested to improve medical adherence.<h4>Methods/design</h4>Design: An investigator-initiated, single-center, single-blind, parallel-group, phase-4 clinical superio ...[more]

PMID: 29415699

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Project description:BackgroundAdherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence.ObjectiveThe primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes.MethodsThis study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations.ResultsPhase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020.ConclusionsThis study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus.Trial registrationClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128.International registered report identifier (irrid)DERR1-10.2196/15356.

Project description:BACKGROUND:The efficacy of smartphone apps for improving medication adherence in type 2 diabetes is not well studied in Asian populations. OBJECTIVE:This study aimed to determine the feasibility, acceptability, and clinical outcomes of using a smartphone app to improve medication adherence in a multiethnic Asian population with type 2 diabetes. METHODS:We block randomized 51 nonadherent and digitally literate patients with type 2 diabetes between the ages of 21 and 75 years into two treatment arms (control: usual care; intervention: usual care+Medisafe app) and followed them up for 12 weeks. Recruitment occurred at a public tertiary diabetes specialist outpatient center in Singapore. The intervention group received email reminders to complete online surveys monthly, while the control group only received an email reminder(s) at the end of the study. Barriers to medication adherence and self-appraisal of diabetes were assessed using the Adherence Starts with Knowledge-12 (ASK-12) and Appraisal of Diabetes Scale (ADS) questionnaires at baseline and poststudy in both groups. Perception toward medication adherence and app usage, attitude, and satisfaction were assessed in the intervention group during and after the follow-up period. Sociodemographic data were collected at baseline. Clinical data (ie, hemoglobin A1c, body mass index, low-density lipoprotein, high-density lipoprotein, and total cholesterol levels) were extracted from patients' electronic medical records. RESULTS:A total of 51 (intervention group: 25 [49%]; control group: 26 [51%]) participants were randomized, of which 41 (intervention group: 22 [88.0%]; control group: 19 [73.1%]) completed the poststudy survey. The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01). No changes were observed in the clinical outcomes. The average 12-week medication adherence rate of participants tracked by the app was between 38.3% and 100% in the intervention group. The majority (>80%) of the participants agreed that the app was easy to use and made them more adherent to their medication. CONCLUSIONS:Our feasibility study showed that among medication-nonadherent patients with type 2 diabetes, a smartphone app intervention was acceptable, improved awareness of medication adherence, and reduced self-reported barriers to medication adherence, but did not improve clinical outcomes in a developed Asian setting.

Project description:BackgroundSince the introduction of assisted reproductive technologies in 1978, over 2 million in vitro fertilization (IVF) babies have been born worldwide. Patients play a vital role in the success of this treatment. They are required to take fertility medication (hormone injections) to activate the ovaries to produce a sufficient number of oocytes. Later, they need to take medication to increase the chance of the embryo surviving inside the uterus. Patients are educated during an intake consultation at the start of the treatment to minimize the emotional burden and reduce noncompliance. The consultation lasts about 30 to 45 minutes and covers all essential subjects. Even though ample time and energy is spent on patient education, patients still feel anxious, unknowledgeable, and unsupported. As such, electronic health utilizing a smartphone or tablet app can offer additional support, as it allows health care professionals to provide their patients with the correct information at the right time by using push notifications.ObjectiveThis randomized controlled trial aimed to evaluate the capacity of an app to support IVF patients throughout the different phases of their treatment and assess its effectiveness. The study's primary outcome was to determine the patients' level of satisfaction with the information provided. The secondary outcomes included their level of knowledge, ability to administer the medication, overall experienced quality of the treatment, health care consumption, and app usage.MethodsThis study was performed at a specialized fertility clinic of the nonacademic teaching hospital Elisabeth-TweeSteden Ziekenhuis in Tilburg, the Netherlands. Patients who were scheduled for IVF or intracytoplasmic sperm injection treatments between April 2018 and August 2019 were invited to participate in a physician-blinded, randomized controlled trial.ResultsIn total, 54 patients participated (intervention group: n=29). Patients in the intervention group demonstrated a higher level of satisfaction on a 0 to 10 scale (mean 8.43, SD 1.03 vs mean 7.70, SD 0.66; P=.004). In addition, they were more knowledgeable about the different elements of the treatment on a 7 to 35 scale (mean 27.29, SD 2.94 vs mean 23.05, SD 2.76; P<.001). However, the difference disappeared over time. There were no differences between the two patient groups on the other outcomes. In total, 25 patients in the intervention group used the app 1425 times, an average of 57 times per patient.ConclusionsOur study demonstrates that, in comparison with standard patient education, using an app to provide patients with timely information increases their level of satisfaction. Furthermore, using the app leads to a higher level of knowledge about the steps and procedures of IVF treatment. Finally, the app's usage statistics demonstrate patients' informational needs and their willingness to use an electronic health application as part of their treatment.Trial registrationNetherlands Trial Register (NTR) 6959; https://www.trialregister.nl/trial/6959.

Project description:BackgroundAlthough behavioral interventions show some promise for reducing stimulant use and achieving durable viral suppression in sexual minority men (SMM) with HIV, scalable mHealth applications are needed to optimize their reach and cost-effectiveness.MethodsSupporting Treatment Adherence for Resilience and Thriving (START) is a randomized controlled trial (RCT) testing the efficacy and cost-effectiveness of a mHealth application that integrates evidence-based positive affect regulation skills with self-monitoring of adherence and mood. The primary outcome is detectable HIV viral load (i.e., > 300 copies/mL) from self-collected dried blood spot (DBS) specimens at 6 months. Secondary outcomes include detectable DBS viral load at 12 months, self-reported stimulant use severity, anti-retroviral therapy (ART) adherence, and positive affect over 12 months. A national sample of up to 250 SMM with HIV who screen positive for stimulant use disorder and reporting suboptimal ART adherence is being recruited via social networking applications through April of 2024. After providing informed consent, participants complete a run-in period (i.e., waiting period) including two baseline assessments with self-report measures and a self-collected DBS sample. Those who complete the run-in period are randomized to either the START mHealth application or access to a website with referrals to HIV care and substance use disorder treatment resources. Participants provide DBS samples at baseline, 6, and 12 months to measure HIV viral load as well as complete self-report measures for secondary outcomes at quarterly follow-up assessments over 12 months.DiscussionTo date, we have paid $117,500 to advertise START on social networking applications and reached 1,970 eligible participants ($59.77 per eligible participant). Although we identified this large national sample of potentially eligible SMM with HIV who screen positive for a stimulant use disorder and report suboptimal ART adherence, only one-in-four have enrolled in the RCT. The run-in period has proven to be crucial for maintaining scientific rigor and reproducibility of this RCT, such that only half of consented participants complete the required study enrollment activities and attended a randomization visit. Taken together, findings will guide adequate resource allocation to achieve randomization targets in future mHealth research SMM with HIV who use stimulants.Trial registrationThis protocol was registered on clinicaltrials.gov (NCT05140876) on December 2, 2021.

Project description:BackgroundA growing body of evidence for digital interventions to improve sleep shows promising effects. The interventions investigated so far have been primarily web-based; however, app-based interventions may reach a wider audience and be more suitable for daily use.ObjectiveThis study aims to evaluate the intervention effects, adherence, and acceptance of an unguided app-based intervention for individuals who wish to improve their sleep.MethodsIn a randomized controlled trial, we evaluated the effects of an app-based short intervention (Refresh) to improve sleep compared with a waitlist condition. Refresh is an 8-week unguided intervention covering the principles of cognitive behavioral therapy for insomnia (CBT-I) and including a sleep diary. The primary outcome was sleep quality (insomnia symptoms) as self-assessed by the Regensburg Insomnia Scale (RIS). The secondary outcomes were depression (9-item Patient Health Questionnaire [PHQ-9] score) and perceived insomnia-related impairment.ResultsWe included 371 participants, of which 245 reported poor sleep at baseline. About 1 in 3 participants who were allocated to the intervention group never accessed the intervention. Active participants completed on average 4 out of 8 chapters. Retention rates were 67.4% (n=250) at postassessment and 57.7% (n=214) at the 6-month follow-up. At postintervention, insomnia symptoms in the intervention group had improved more than those in the waitlist group, with a small effect (d=0.26) in the whole sample and a medium effect (d=0.45) in the subgroup with poor sleep. Effects in the intervention group were maintained at follow-up. Perceived insomnia-related impairment also improved from pre- to postassessment. No significant intervention effect on depression was detected. Working alliance and acceptance were moderate to good.ConclusionsAn app-based, unguided intervention is a feasible and effective option to scale-up CBT-I-based treatment, but intervention uptake and adherence need to be carefully addressed.Trial registrationISRCTN Registry ISRCTN53553517; https://www.isrctn.com/ISRCTN53553517.

Dataset Information

Can an app supporting psoriasis patients improve adherence to topical treatment? A single-blind randomized controlled trial.

Publications

Can an app supporting psoriasis patients improve adherence to topical treatment? A single-blind randomized controlled trial.

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