AdherencePhase 4NCT02858713
Adherence in Topical Treatment of Psoriasis
A Phase 4 study testing Calcipotriene + Betamethasone Dipropionate and App in people with Adherence, run by Odense University Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adherence
- What is being tested?
- Calcipotriene + Betamethasone Dipropionate and App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Jan 2017to 29 Aug 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can an App Supporting Psoriasis Patients Improve Adherence to Topical Treatment? A Single-blind Randomized Controlled Trial
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©).
Read more
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
Read the 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.
- Conditions
- Adherence
- Being tested
- Calcipotriene + Betamethasone Dipropionate, App
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriene + Betamethasone DipropionateDrug
Also called Enstilar
Participants received Calcipotriene + Betamethasone Dipropionate once daily when needed for the entire study period.
AppDevice
Also called Mypso app
App named MyPso SmarTopTM Version 1.0 (LEO Pharma) was used for 28 days by participants in the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| App as intervention + Enstilar© | Experimental | Patients prescribed Calcipotriene + Betamethasone Dipropionatecutaneous foam receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation. Receives: Drug: Calcipotriene + Betamethasone Dipropionate; Device: App |
| Conventional instructions + Enstilar© | No intervention | Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 4
Secondary outcomes (2)
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.
Measured: Baseline, week 4, 8 and 26
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.
Measured: Week 4, 8 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start9 Jan 2017
- Primary completion29 Apr 2017
- Study completion29 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AdherenceStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Tiedemann Svendsen, Odense University Hospital
- Investigators
- Mathias Tiedemann Svendsen, MD, PhD, Principal investigator, Department of Dermatology and Allergy Centre, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858713
- Sponsor's protocol ID
- 2016-002143-42
- Other IDs
- 2016
- Status last verified
- Feb 2019
- First submitted
- 3 Aug 2016
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29415699Svendsen MT, Andersen F, Andersen KH, Pottegard A, Johannessen H, Moller 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 Dermatol. 2018 Nov;179(5):1062-1071. doi: 10.1111/bjd.16667. Epub 2018 Jul 5.
PubMed 29654699
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can an App Supporting Psoriasis Patients Improve Adherence to Topical Treatment? A Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02858713
- Acronym / sponsor ID
- 2016-002143-42
- Conditions
- Adherence
- Keywords
- psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 29 Apr 2017 (actual)
- Study completion
- 29 Aug 2017 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App as intervention + Enstilar© | Experimental | Drug: Calcipotriene + Betamethasone Dipropionate, Device: AppPatients prescribed Calcipotriene + Betamethasone Dipropionatecutaneous foam receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation. |
| Conventional instructions + Enstilar© | No intervention | –Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcipotriene + Betamethasone DipropionateAlso: EnstilarParticipants received Calcipotriene + Betamethasone Dipropionate once daily when needed for the entire study period. | Drug | App as intervention + Enstilar© |
| AppAlso: Mypso appApp named MyPso SmarTopTM Version 1.0 (LEO Pharma) was used for 28 days by participants in the intervention arm. | Device | App as intervention + Enstilar© |
Primary outcome
Percentage of Adherent Participants
Time frame: 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
2 secondary outcomes
Dermatology Life Quality Index (DLQI)
Time frame: Baseline, week 4, 8 and 26
Lattice-System Physician's Global Assessment (LS-PGA)
Time frame: Week 4, 8 and 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29415699Svendsen 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.
- Results publication: PubMed 29654699Svendsen MT, Andersen F, Andersen KH, Pottegard A, Johannessen H, Moller 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 Dermatol. 2018 Nov;179(5):1062-1071. doi: 10.1111/bjd.16667. Epub 2018 Jul 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Tiedemann Svendsen, MD, PhD principal investigator
Department of Dermatology and Allergy Centre, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcipotriene + Betamethasone Dipropionate and App in people with Adherence, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Adherent Participants (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02858713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.