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

Mathias Tiedemann Svendsen, Flemming Andersen, Kirsten Hammond Andersen, Klaus Ejner Andersen, Mathias Tiedemann Svendsen, Flemming Andersen, Kirsten Hammond Andersen, Klaus Ejner Andersen

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.

Keywords: Adherence; App; Electronic monitor; Psoriasis; Randomized controlled trial (RCT); Smartphone.

Conflict of interest statement

Ethics approval and consent to participate

The trial has been approved by the Regional Committees on Health Research Ethics for Southern Denmark, Denmark (S-20160068G).

Written consent has been obtained from all participants at the baseline visit, where all participants signed an informed consent form.

Consent for publication

Not applicable.

Competing interests

KEA and MTS have received a grant from LEO® to conduct the trial. The EM and app are developed and owned by LEO®. FA and KHA have no conflicts of interests. the authors declare that they

have no competing interests

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow of participants during the trial period

References

    1. Parisi R, Symmons DP, Griffiths CE, Ashcroft DM. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J invest dermatol. 2013;133(2):377–385. doi: 10.1038/jid.2012.339.
    1. Stein Gold L, Corvari L. The roles of safety and compliance in determining effectiveness of topical therapy for psoriasis. Cutis. 2007;79(1 Suppl 2):32–38.
    1. Mason AR, Mason J, Cork M, Dooley G, Hancock H. Topical treatments for chronic plaque psoriasis. Cochrane Database Syst Rev. 2013;3:CD005028.
    1. Storm A, Andersen SE, Benfeldt E, Serup J. One in 3 prescriptions are never redeemed: primary nonadherence in an outpatient clinic. J Am Acad Dermatol. 2008;59(1):27–33. doi: 10.1016/j.jaad.2008.03.045.
    1. Urquhart J. The odds of the three nons when an aptly prescribed medicine isn't working: non-compliance, non-absorption, non-response. Br J Clin Pharmacol. 2002;54(2):212–220. doi: 10.1046/j.1365-2125.2002.01629.x.
    1. Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, Agoritsas T, Mistry N, Iorio A, Jack S, et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2014;11:Cd000011.
    1. Svendsen MT, Andersen F, Andersen KE. eHealth technologies as an intervention to improve adherence to topical antipsoriatics: a systematic review. J dermatol treat. 2017:1–6. 10.1080/09546634.2017.1341612. [Epub ahead of print].
    1. Svendsen MT, Andersen F, Hansen J, Johannessen H, Andersen KE. Medical adherence to topical corticosteroid preparations prescribed for psoriasis: a systematic review. J dermatol treat. 2017;28(1):32–39. doi: 10.1080/09546634.2016.1178375.
    1. Svendsen MT, Jeyabalan J, Andersen KE, Andersen F, Johannessen H. Worldwide utilization of topical remedies in treatment of psoriasis: a systematic review. J dermatol treat. 2017;28(5):374–383. doi: 10.1080/09546634.2016.1254331.
    1. Brown KK, Rehmus WE, Kimball AB. Determining the relative importance of patient motivations for nonadherence to topical corticosteroid therapy in psoriasis. J Am Acad Dermatol. 2006;55(4):607–613. doi: 10.1016/j.jaad.2005.12.021.
    1. Feldman SR. Disease burden and treatment adherence in psoriasis patients. Cutis. 2013;92(5):258–263.
    1. Chan SA, Hussain F, Lawson LG, Ormerod AD. Factors affecting adherence to treatment of psoriasis: comparing biologic therapy to other modalities. J dermatol treat. 2013;24(1):64–69. doi: 10.3109/09546634.2011.607425.
    1. Saeki H, Imafuku S, Abe M, Shintani Y, Onozuka D, Hagihara A, Katoh N, Murota H, Takeuchi S, Sugaya M, et al. Poor adherence to medication as assessed by the Morisky medication adherence Scale-8 and low satisfaction with treatment in 237 psoriasis patients. J Dermatol. 2015;42(4):367–372. doi: 10.1111/1346-8138.12804.
    1. Burroni AG, Fassino M, Torti A, Visentin E. How do disease perception, treatment features, and dermatologist-patient relationship impact on patients assuming topical treatment? An Italian survey. Patient Relat Outcome Meas. 2015;6:9–17.
    1. Zaghloul SS, Goodfield MJ. Objective assessment of compliance with psoriasis treatment. Arch Dermatol. 2004;140(4):408–414. doi: 10.1001/archderm.140.4.408.
    1. Storm A, Benfeldt E, Andersen SE, Serup J. A prospective study of patient adherence to topical treatments: 95% of patients underdose. J Am Acad Dermatol. 2008;59(6):975–980. doi: 10.1016/j.jaad.2008.07.039.
    1. Ersser SJ, Cowdell FC, Latter SM, Healy E. Self-management experiences in adults with mild-moderate psoriasis: an exploratory study and implications for improved support. Br J Dermatol. 2010;163(5):1044–1049. doi: 10.1111/j.1365-2133.2010.09916.x.
    1. Bewley A, Burrage DM, Ersser SJ, Hansen M, Ward C. Identifying individual psychosocial and adherence support needs in patients with psoriasis: a multinational two-stage qualitative and quantitative study. J Eur Acad Dermatol Venereol: JEADV. 2014;28(6):763–770. doi: 10.1111/jdv.12174.
    1. Svedbom A, Dalen J, Mamolo C, Cappelleri J, Petersson I, Ståhle M. Treatment patterns with topicals, traditional systemics and biologics in psoriasis–a Swedish database analysis. J Eur Acad Dermatol Venereol. 2015;29(2):215–223. doi: 10.1111/jdv.12494.
    1. de Korte J, Van Onselen J, Kownacki S, Sprangers MA, Bos JD. Quality of care in patients with psoriasis: an initial clinical study of an international disease management programme. J Eur Acad Dermatol Venereol. 2005;19(1):35–41. doi: 10.1111/j.1468-3083.2004.01107.x.
    1. Alinia H, Moradi Tuchayi S, Smith JA, Richardson IM, Bahrami N, Jaros SC, Sandoval LF, Farhangian ME, Anderson KL, Huang KE, et al. Long-term adherence to topical psoriasis treatment can be abysmal: a 1-year randomized intervention study using objective electronic adherence monitoring. Br J Dermatol. 2017;176(3):759–764. doi: 10.1111/bjd.15085.
    1. Saeki H, Watanabe A, Tada Y, Kakinuma T, Komine M, Ihn H, Asahina A, Etoh T, Kitanaka S, Sato U, et al. Juvenile pustular psoriasis associated with steroid withdrawal syndrome due to topical corticosteroid. J Dermatol. 2008;35(9):601–603. doi: 10.1111/j.1346-8138.2008.00531.x.
    1. WHO: Atlas of eHealth country profiles: the use of eHealth in support of universal health coverage: based on the findings of the third global survey on eHealth 2015. Geneva, Switzerland: World Health Organization 2016.
    1. Yetisen AK, Martinez-Hurtado J, da Cruz Vasconcellos F, Simsekler ME, Akram MS, Lowe CR. The regulation of mobile medical applications. Lab Chip. 2014;14(5):833–840. doi: 10.1039/c3lc51235e.
    1. BinDhim NF, Trevena L. There’s an app for that: a guide for healthcare practitioners and researchers on smartphone technology. Online j pub health info. 2015;7(2):e218. 10.5210/ojphi.v7i2.5522. eCollection 2015.
    1. Balato N, Megna M, Di Costanzo L, Balato A, Ayala F. Educational and motivational support service: a pilot study for mobile-phone-based interventions in patients with psoriasis. Br J Dermatol. 2013;168(1):201–205. doi: 10.1111/j.1365-2133.2012.11205.x.
    1. Thaler RH, Sunstein CR. Nudge: improving decisions about health, wealth, and happiness revised and expanded edition. New York: Penguin; 2009.
    1. Snyder A, Taheri A. Dealing with Forgetfullness. In: Davis SA, editor. Adherence in dermatology. Switzerland: Springer international publishing. 2016. pp. 163–170.
    1. Enstilar [product resumé], Danish Medicines Agency, Copenhagen. April 2016. . Accessed 8 Aug 2017.
    1. Balkrishnan R, Carroll CL, Camacho FT, Feldman SR. Electronic monitoring of medication adherence in skin disease: results of a pilot study. J Am Acad Dermatol. 2003;49(4):651–654. doi: 10.1067/S0190-9622(03)00912-5.
    1. Berth-Jones J, Grotzinger K, Rainville C, Pham B, Huang J, Daly S, Herdman M, Firth P, Hotchkiss K. A study examining inter- and intrarater reliability of three scales for measuring severity of psoriasis: psoriasis area and severity index, Physician's global assessment and lattice system Physician's global assessment. Br J Dermatol. 2006;155(4):707–713. doi: 10.1111/j.1365-2133.2006.07389.x.
    1. Chow C, Simpson MJ, Luger TA, Chubb H, Ellis CN. Comparison of three methods for measuring psoriasis severity in clinical studies (part 1 of 2): change during therapy in psoriasis area and severity index, static Physician's global assessment and lattice system Physician's global assessment. J Eur Acad Dermatol Venereol. 2015;29(7):1406–1414. doi: 10.1111/jdv.13132.
    1. Simpson MJ, Chow C, Morgenstern H, Luger TA, Ellis CN. Comparison of three methods for measuring psoriasis severity in clinical studies (part 2 of 2): use of quality of life to assess construct validity of the lattice system Physician's global assessment, psoriasis area and severity index and static Physician's global assessment. J Eur Acad Dermatol Venereol. 2015;29(7):1415–1420. doi: 10.1111/jdv.12861.
    1. Langley RG, Ellis CN. Evaluating psoriasis with psoriasis area and severity index, psoriasis global assessment, and lattice system Physician's global assessment. J Am Acad Dermatol. 2004;51(4):563–569. doi: 10.1016/j.jaad.2004.04.012.
    1. Zachariae R, Zachariae C, Ibsen H, Mortensen JT, Wulf HC. Dermatology life quality index: data from Danish inpatients and outpatients. Acta Derm Venereol. 2000;80(4):272–276. doi: 10.1080/000155500750012153.
    1. INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH) ICH HARMONISED GUIDELINE INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2) Current Step 4 version dated 9 November 2016. Integreated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2). . Accessed 8 Aug 2017.
    1. Queille-Roussel C, Clonier F, Olesen M. Short-contact treatment with calcipotriene plus betamethasone dipropionate topical suspension in a psoriasis plaque test model. J Am Acad Dermatol. 2014;1:AB190.
    1. Koo J, Tyring S, Werschler WP, Bruce S, Olesen M, Villumsen J, Bagel J. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris - a randomized phase II study. J dermatol treat. 2016;27(2):120–127. doi: 10.3109/09546634.2015.1083935.
    1. Leonardi C, Bagel J, Yamauchi P, Pariser D, Xu Z, Olesen M, Osterdal ML, Stein Gold L. Efficacy and safety of Calcipotriene plus Betamethasone Dipropionate aerosol foam in patients with psoriasis Vulgaris--a randomized phase III study (PSO-FAST) J Drugs Dermatol. 2015;14(12):1468–1477.
    1. Den nationale Videnskabsetiske Komité. Forsøgspersoners rettigheder i et sundhedsvidenskabeligt forskningsprojekt. København. August 2014. . Accessed 8 Aug 2017.
    1. Patel NU, Moore BA, Craver RF, Feldman SR. Ethical considerations in adherence research. Patient prefer adherence. 2016;10:2429. doi: 10.2147/PPA.S117802.
    1. Krejci-Manwaring J, Tusa MG, Carroll C, Camacho F, Kaur M, Carr D, Fleischer AB, Jr, Balkrishnan R, Feldman SR. Stealth monitoring of adherence to topical medication: adherence is very poor in children with atopic dermatitis. J Am Acad Dermatol. 2007;56(2):211–216. doi: 10.1016/j.jaad.2006.05.073.
    1. Yentzer BA, Alikhan A, Teuschler H, Williams LL, Tusa M, Fleischer AB, Jr, Kaur M, Balkrishnan R, Feldman SR. An exploratory study of adherence to topical benzoyl peroxide in patients with acne vulgaris. J Am Acad Dermatol. 2009;60(5):879–880. doi: 10.1016/j.jaad.2008.11.019.
    1. Danish Data Protection Agency, Compiled version on the Act on Processing o0f Personal Data. Copenhagen,.2007. . Accessed 8 Aug 2017.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe