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NCT Number: NCT05171270

AsseSSing Impact in pSoriatic Treatment

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.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Gabriel-Montpied, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

PsAID questionnaire

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Patients Undergoing Reduction of Therapy

    Time frame: During the consultation visit (around 30-60 mins)

    Treatment reduction definition includes decrease in dose, frequency, change in route, stopping medication

  2. Mean PsAID-12 Scores

    Time frame: During the consultation visit (around 30-60 mins)

    PsA impact of disease score (scale 0-10 where higher score is worse)

  3. Median CollaboRATE Score

    Time frame: During the consultation visit (around 30-60 mins)

    Patient satisfaction with consultation (scale 0-9 where higher score is better)

  4. Median Perceived Efficacy on Patient-physician Interaction Score (PEPPI)

    Time frame: During the consultation visit (around 30-60 mins)

    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)

  5. Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision

    Time frame: During the consultation visit (around 30-60 mins)

    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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Amgen

Registry information

Official study title

How Does PsAID Implementation Affect Treatment Intensification and Patient Satisfaction in PsA

Acronym: ASSIST

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2021
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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