AsseSSing Impact in pSoriatic Treatment (ASSIST)

May 18, 2022 updated by: University of Oxford

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
  • Germany
      • Bamberg, Germany
        • Recruiting
        • Klinikum Bamburg
        • Contact:
          • Axel Hueber
      • Berlin, Germany
        • Recruiting
        • Rheumatologische Schwerpunktpraxis
        • Contact:
          • Jan Brandt-Jurgens
      • Frankfurt, Germany
        • Recruiting
        • Universitätsklinik Frankfurt
        • Contact:
          • Michaela Kohm
      • Herne, Germany
      • Planegg, Germany
        • Recruiting
        • MVZ für Rheumatologie Dr. Martin Welcker GmbH
        • Contact:
          • Martin Welcker
  • Italy
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Clinic (Barcelona)
        • Contact:
      • Coruña, Spain
      • Madrid, Spain
      • Oviedo, Spain
        • Not yet recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
      • Salamanca, Spain
  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX39DU
        • Recruiting
        • Oxford University Hospital NHS Foundation Trust
        • Contact:
    • Staffordshire
      • Stafford, Staffordshire, United Kingdom, ST16 3SR
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4HH
    • Yorkshire
      • Bradford, Yorkshire, United Kingdom, BD9 6RJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult participants with a diagnosis of PsA

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Psoriatic arthritis
Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation.
Other: Questionnaire
PsAID questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients undergoing treatment escalation
Time Frame: During the consultation (cross sectional study so only one timepoint)
Treatment escalation definition includes increase in dose, frequency, change of route, new medication
During the consultation (cross sectional study so only one timepoint)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of therapy
Time Frame: During the consultation (cross sectional study so only one timepoint)
Treatment reduction definition includes decrease in dose, frequency, change in route, stopping medication
During the consultation (cross sectional study so only one timepoint)
PsAID-12 scores
Time Frame: During the consultation (cross sectional study so only one timepoint)
PsA impact of disease score (scale 0-10 where higher score is worse)
During the consultation (cross sectional study so only one timepoint)
CollaboRATE score
Time Frame: During the consultation (cross sectional study so only one timepoint)
Patient satisfaction with consultation (scale 0-9 where higher score is better)
During the consultation (cross sectional study so only one timepoint)
Perceived efficacy on Patient-physician interaction score (PEPPI)
Time Frame: During the consultation (cross sectional study so only one timepoint)
Perceived efficacy in consultation (scale 5-25 where higher score is better)
During the consultation (cross sectional study so only one timepoint)
Physicians opinion of how much arthritis is driving treatment decision
Time Frame: During the consultation (cross sectional study so only one timepoint)
Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
During the consultation (cross sectional study so only one timepoint)
Physicians opinion of how PsAID 12 influenced treatment decision
Time Frame: During the consultation (cross sectional study so only one timepoint)
Likert scale 1-5 (scale 0-5 where higher score is worse)
During the consultation (cross sectional study so only one timepoint)
Physicians opinion of how much enthesitis is driving treatment decision
Time Frame: During the consultation (cross sectional study so only one timepoint)
Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
During the consultation (cross sectional study so only one timepoint)
Physicians opinion of how much psoriasis is driving treatment decision
Time Frame: During the consultation (cross sectional study so only one timepoint)
Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
During the consultation (cross sectional study so only one timepoint)
Physicians opinion of how much systemic inflammation marker (CRP) is driving treatment decision
Time Frame: During the consultation (cross sectional study so only one timepoint)
Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
During the consultation (cross sectional study so only one timepoint)
Physicians opinion of how much PROs are driving treatment decision
Time Frame: During the consultation (cross sectional study so only one timepoint)
Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
During the consultation (cross sectional study so only one timepoint)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Actual)

March 22, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 287039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Available on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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