Adherence
Conditions
Keywords
psoriasis
Brief 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
Detailed 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.
Interventions
DRUGCalcipotriene + Betamethasone Dipropionate
Participants received Calcipotriene + Betamethasone Dipropionate once daily when needed for the entire study period.
DEVICEApp
App named MyPso SmarTopTM Version 1.0 (LEO Pharma) was used for 28 days by participants in the intervention arm.
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Adherent Participants | Week 4 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology Life Quality Index (DLQI) | Baseline, week 4, 8 and 26 | 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. |
| Lattice-System Physician's Global Assessment (LS-PGA) | Week 4, 8 and 26 | 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. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| App as Intervention + Enstilar© Patients prescribed Enstilar© receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.
Enstilar 0.005%-0.064% Topical Foam | 68 |
| Conventional Instructions + Enstilar© Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.
Enstilar 0.005%-0.064% Topical Foam | 66 |
| Total | 134 |
Baseline characteristics
| Characteristic | Conventional Instructions + Enstilar© | Total | App as Intervention + Enstilar© |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 28 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 106 Participants | 53 Participants |
| Age, Continuous | 48 years | 48 years | 50 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Denmark | 66 Participants | 134 Participants | 68 Participants |
| Sex: Female, Male Female | 25 Participants | 52 Participants | 27 Participants |
| Sex: Female, Male Male | 41 Participants | 82 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 68 |
| other Total, other adverse events | 22 / 66 | 20 / 68 |
| serious Total, serious adverse events | 0 / 66 | 1 / 68 |
Outcome results
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
Time frame: Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| App as Intervention + Enstilar© | Percentage of Adherent Participants | 65 percentage of participants |
| Conventional Instructions + Enstilar© | Percentage of Adherent Participants | 38 percentage of participants |
p-value: =0.00495% CI: [1.42, 6.28]Regression, Logistic
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.
Time frame: Baseline, week 4, 8 and 26
Population: Patients lost to follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| App as Intervention + Enstilar© | Dermatology Life Quality Index (DLQI) | Change from baseline to week 4 | 4.54 units on a scale |
| App as Intervention + Enstilar© | Dermatology Life Quality Index (DLQI) | Change from baseline to week 8 | 5.17 units on a scale |
| App as Intervention + Enstilar© | Dermatology Life Quality Index (DLQI) | Change from baseline to week 26 | 5.00 units on a scale |
| Conventional Instructions + Enstilar© | Dermatology Life Quality Index (DLQI) | Change from baseline to week 4 | 4.12 units on a scale |
| Conventional Instructions + Enstilar© | Dermatology Life Quality Index (DLQI) | Change from baseline to week 8 | 4.59 units on a scale |
| Conventional Instructions + Enstilar© | Dermatology Life Quality Index (DLQI) | Change from baseline to week 26 | 4.23 units on a scale |
Comparison: DLQI: Change baseline to week 4p-value: =0.54595% CI: [-1.77, 0.939]Regression, Linear
Comparison: DLQI: Change from baseline to week 4p-value: 0.54595% CI: [-1.77, 0.939]Regression, Linear
Comparison: DLQI: Change from baseline to week 8p-value: 0.4595% CI: [-2.099, 0.938]Regression, Linear
Comparison: DLQI: Change from baseline to week 26p-value: 0.34895% CI: [-2.389, 0.848]Regression, Linear
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.
Time frame: Week 4, 8 and 26
Population: Lost to follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| App as Intervention + Enstilar© | Lattice-System Physician's Global Assessment (LS-PGA) | Change from baseline to week 4 | 1.46 units on a scale |
| App as Intervention + Enstilar© | Lattice-System Physician's Global Assessment (LS-PGA) | Change from baseline to week 8 | 2.16 units on a scale |
| App as Intervention + Enstilar© | Lattice-System Physician's Global Assessment (LS-PGA) | Change from baseline to week 26 | 1.80 units on a scale |
| Conventional Instructions + Enstilar© | Lattice-System Physician's Global Assessment (LS-PGA) | Change from baseline to week 4 | 1.86 units on a scale |
| Conventional Instructions + Enstilar© | Lattice-System Physician's Global Assessment (LS-PGA) | Change from baseline to week 8 | 2.25 units on a scale |
| Conventional Instructions + Enstilar© | Lattice-System Physician's Global Assessment (LS-PGA) | Change from baseline to week 26 | 1.98 units on a scale |
Comparison: LS-PGA: Change from baseline to week 4p-value: 0.04795% CI: [0.005, 0.795]Regression, Linear
Comparison: LS-PGA: Change from baseline to week 8p-value: 0.66295% CI: [-0.321, 0.504]Regression, Linear
Comparison: LS-PGA: Change from baseline to week 26p-value: 0.42495% CI: [-0.264, 0.625]Regression, Linear