Psoriatic ArthritisASSISTNCT05171270
AsseSSing Impact in pSoriatic Treatment
An observational study of Psoriatic Arthritis, run by University of Oxford at 21 sites in 5 countries.
Trial summary
Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Questionnaire
- How many people
- 503 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 12 Jul 2021to 22 Mar 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with a diagnosis of PsA
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study and complete questionnaires in the local language.
- Aged 18 years or above.
- Diagnosed with PsA according to the ClASification of Psoriatic ARthritis (CASPAR) criteria and diagnosis confirmed by a rheumatologist (Taylor 2006).
Who cannot join
- Patients who don't speak or read the local language
- Patients who are not comfortable filling in an app-based questionnaire or paper CRF.
- Patients with a new diagnosis of PsA at the current clinic visit
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
France5 sites
CHU Gabriel-Montpied
Clermont-Ferrand, 63000
Centre Hospitalier Le Mans
Le Mans
Hopitaux Universitaires de Marseille
Marseille
GERPAL, Hopital de la Pitie
Paris, 75651
Centre Hospitalier Universitaire (CHU) de Toulouse
Toulouse
Germany5 sites
Klinikum Bamburg
Bamberg
Rheumatologische Schwerpunktpraxis
Berlin
Universitatsklinik Frankfurt
Frankfurt
Universitätsklinikum der Ruhr-Universität Bochum
Herne
MVZ für Rheumatologie Dr. Martin Welcker GmbH
Planegg
Spain5 sites
Complejo Universitario de a Coruña
A Coruña
Hospital Clinic (Barcelona)
Barcelona
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Central de Asturias
Oviedo
Hospital Universitario de Salamanca
Salamanca
United Kingdom5 sites
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, Yorkshire, BD9 6RJ
Cardiff and Vale University LHB
Cardiff, Wales, CF14 4HH
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL
Oxford University Hospital NHS Foundation Trust
Oxford, Oxfordshire, OX39DU
Midlands Partnership NHS Foundation Trust
Stafford, Staffordshire, ST16 3SR
About this study
Official title: How Does PsAID Implementation Affect Treatment Intensification and Patient Satisfaction in PsA
Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice.
This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA.
This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.
Read the detailed description
This is an observational, cross-sectional study addressing the factors influencing treatment decisions in patients with PsA. Participants will be treated as usual in their routine clinical practice, but decisions on treatment will be recorded - whether treatment is escalated, unchanged or reduced, and why.
The study will be conducted in 25 rheumatology centres in Europe (UK, France, Germany, Spain and Italy) with five centres in each country. Each participant will only attend for one single study visit which is likely to last around 30 minutes in total. This will be alongside the participant's routine clinic visit. The PsAID-12 questionnaire will be implemented on a tablet computer but the remaining outcomes will be collected on paper CRFs and transferred to a database for analysis.
- Conditions
- Psoriatic Arthritis
- Being tested
- Questionnaire
- Keywords
- Treatment decisions, Impact of disease
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
PsAID questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis | Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Undergoing Treatment Escalation
Treatment escalation definition includes increase in dose, frequency, change of route, new medication
Measured: During the consultation visit (around 30-60 mins)
Secondary outcomes (5)
Number of Patients Undergoing Reduction of Therapy
Treatment reduction definition includes decrease in dose, frequency, change in route, stopping medication
Measured: During the consultation visit (around 30-60 mins)
Mean PsAID-12 Scores
PsA impact of disease score (scale 0-10 where higher score is worse)
Measured: During the consultation visit (around 30-60 mins)
Median CollaboRATE Score
Patient satisfaction with consultation (scale 0-9 where higher score is better)
Measured: During the consultation visit (around 30-60 mins)
Median Perceived Efficacy on Patient-physician Interaction Score (PEPPI)
A patient-reported questionnaire to assess their perceived efficacy in a healthcare consultation. This consists of 5 questions which the patient rates on a likert scale of 1 to 5. The score for each of the questions are summed together giving a score range of 5-25 where higher score is better)
Measured: During the consultation visit (around 30-60 mins)
Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision
Likert scale 1-5 where
- A lot more likely to decrease or not change therapy
- Somewhat more likely to decrease or not change therapy
- No impact on treatment decision
- Somewhat more likely to increase therapy
- A lot more likely to increase therapy A higher score means that the PsAID 12 was more likely to influence treatment decisions.
Measured: During the consultation visit (around 30-60 mins)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start12 Jul 2021
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
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 (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171270
- Sponsor's protocol ID
- 287039
- Acronym
- ASSIST
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2021
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available on reasonable request
Publications
Watson L, Coyle C, Whately-Smith C, Brooke M, Kiltz U, Lubrano E, Queiro R, Trigos D, Brandt-Juergens J, Choy E, D'Angelo S, Delle Sedie A, Dernis E, Guis S, Helliwell P, Ho P, Hueber AJ, Joven B, Koehm M, Montilla C, Packham J, Pinto Tasende JA, Ramirez Garcia FJ, Ruyssen-Witrand A, Scrivo R, Twigg S, Soubrier M, Wirth T, Gossec L, Coates LC. An international multicentre analysis of current prescribing practices and shared decision-making in psoriatic arthritis. Rheumatology (Oxford). 2024 Dec 1;63(12):3449-3456. doi: 10.1093/rheumatology/kead621.
PubMed 38011669
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does PsAID Implementation Affect Treatment Intensification and Patient Satisfaction in PsA
- ClinicalTrials.gov ID
- NCT05171270
- Acronym / sponsor ID
- ASSIST / 287039
- Conditions
- Psoriatic Arthritis
- Keywords
- Treatment decisions, Impact of disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice.
This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA.
This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.
Detailed description
This is an observational, cross-sectional study addressing the factors influencing treatment decisions in patients with PsA. Participants will be treated as usual in their routine clinical practice, but decisions on treatment will be recorded - whether treatment is escalated, unchanged or reduced, and why.
The study will be conducted in 25 rheumatology centres in Europe (UK, France, Germany, Spain and Italy) with five centres in each country. Each participant will only attend for one single study visit which is likely to last around 30 minutes in total. This will be alongside the participant's routine clinic visit. The PsAID-12 questionnaire will be implemented on a tablet computer but the remaining outcomes will be collected on paper CRFs and transferred to a database for analysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis | – | Other: QuestionnairePsoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with a diagnosis of PsA
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study and complete questionnaires in the local language.
- Aged 18 years or above.
- Diagnosed with PsA according to the ClASification of Psoriatic ARthritis (CASPAR) criteria and diagnosis confirmed by a rheumatologist (Taylor 2006).
Key exclusion criteria (3 listed)
- Patients who don't speak or read the local language
- Patients who are not comfortable filling in an app-based questionnaire or paper CRF.
- Patients with a new diagnosis of PsA at the current clinic visit
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 |
|---|---|---|
| QuestionnairePsAID questionnaire | Other | Psoriatic arthritis |
Primary outcome
Number of Patients Undergoing Treatment Escalation
Time frame: During the consultation visit (around 30-60 mins)
Treatment escalation definition includes increase in dose, frequency, change of route, new medication
5 secondary outcomes
Number of Patients Undergoing Reduction of Therapy
Time frame: During the consultation visit (around 30-60 mins)
Mean PsAID-12 Scores
Time frame: During the consultation visit (around 30-60 mins)
Median CollaboRATE Score
Time frame: During the consultation visit (around 30-60 mins)
Median Perceived Efficacy on Patient-physician Interaction Score (PEPPI)
Time frame: During the consultation visit (around 30-60 mins)
Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision
Time frame: During the consultation visit (around 30-60 mins)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38011669Watson L, Coyle C, Whately-Smith C, Brooke M, Kiltz U, Lubrano E, Queiro R, Trigos D, Brandt-Juergens J, Choy E, D'Angelo S, Delle Sedie A, Dernis E, Guis S, Helliwell P, Ho P, Hueber AJ, Joven B, Koehm M, Montilla C, Packham J, Pinto Tasende JA, Ramirez Garcia FJ, Ruyssen-Witrand A, Scrivo R, Twigg S, Soubrier M, Wirth T, Gossec L, Coates LC. An international multicentre analysis of current prescribing practices and shared decision-making in psoriatic arthritis. Rheumatology (Oxford). 2024 Dec 1;63(12):3449-3456. doi: 10.1093/rheumatology/kead621.
- Individual participant dataSharing planned: Undecided. Available on reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by University of Oxford at 21 sites in 5 countries.
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 3 inclusion and 3 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 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, Germany, Spain, United Kingdom, Italy. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2024). 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?
Number of Patients Undergoing Treatment Escalation (time frame: During the consultation visit (around 30-60 mins)). 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 NCT05171270, which also lists 1 linked publication.
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 25 Sep 2024.