Psoriatic Arthritis
Conditions
Keywords
Treatment decisions, Impact of disease
Brief 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. 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.
Interventions
OTHERQuestionnaire
PsAID questionnaire
Sponsors
Amgen
University of Oxford
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Undergoing Treatment Escalation | During the consultation visit (around 30-60 mins) | Treatment escalation definition includes increase in dose, frequency, change of route, new medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Undergoing Reduction of Therapy | During the consultation visit (around 30-60 mins) | Treatment reduction definition includes decrease in dose, frequency, change in route, stopping medication |
| Mean PsAID-12 Scores | During the consultation visit (around 30-60 mins) | PsA impact of disease score (scale 0-10 where higher score is worse) |
| Median CollaboRATE Score | During the consultation visit (around 30-60 mins) | Patient satisfaction with consultation (scale 0-9 where higher score is better) |
| Median Perceived Efficacy on Patient-physician Interaction Score (PEPPI) | 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) |
| Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision | During the consultation visit (around 30-60 mins) | Likert scale 1-5 where 1. A lot more likely to decrease or not change therapy 2. Somewhat more likely to decrease or not change therapy 3. No impact on treatment decision 4. Somewhat more likely to increase therapy 5. A lot more likely to increase therapy A higher score means that the PsAID 12 was more likely to influence treatment decisions. |
Countries
France, Germany, Italy, Spain, United Kingdom
Participant flow
Recruitment details
Recruitment in rheumatology outpatient clinics at sites between 12/07/2021 and 22/03/2022
Participants by arm
| Arm | Count |
|---|---|
| Psoriatic Arthritis Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation.
Questionnaire: PsAID questionnaire | 503 |
| Total | 503 |
Baseline characteristics
| Characteristic | Psoriatic Arthritis | — |
|---|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 12.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 100 participants | — |
| Region of Enrollment Germany | 101 participants | — |
| Region of Enrollment Italy | 84 participants | — |
| Region of Enrollment Spain | 111 participants | — |
| Region of Enrollment United Kingdom | 107 participants | — |
| Sex: Female, Male Female | 247 Participants | — |
| Sex: Female, Male Male | 256 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 503 |
| other Total, other adverse events | 0 / 503 |
| serious Total, serious adverse events | 0 / 503 |
Outcome results
Primary
Number of Patients Undergoing Treatment Escalation
Treatment escalation definition includes increase in dose, frequency, change of route, new medication
Time frame: During the consultation visit (around 30-60 mins)
Population: Full population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Psoriatic Arthritis | Number of Patients Undergoing Treatment Escalation | 160 Participants |
Secondary
Mean PsAID-12 Scores
PsA impact of disease score (scale 0-10 where higher score is worse)
Time frame: During the consultation visit (around 30-60 mins)
Population: Full population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriatic Arthritis | Mean PsAID-12 Scores | 3.6 score on a scale | Standard Deviation 2.5 |
Secondary
Median CollaboRATE Score
Patient satisfaction with consultation (scale 0-9 where higher score is better)
Time frame: During the consultation visit (around 30-60 mins)
Population: Full population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Psoriatic Arthritis | Median CollaboRATE Score | 9 score on a scale |
Secondary
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)
Time frame: During the consultation visit (around 30-60 mins)
Population: Full population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Psoriatic Arthritis | Median Perceived Efficacy on Patient-physician Interaction Score (PEPPI) | 23 score on a scale |
Secondary
Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision
Likert scale 1-5 where 1. A lot more likely to decrease or not change therapy 2. Somewhat more likely to decrease or not change therapy 3. No impact on treatment decision 4. Somewhat more likely to increase therapy 5. A lot more likely to increase therapy A higher score means that the PsAID 12 was more likely to influence treatment decisions.
Time frame: During the consultation visit (around 30-60 mins)
Population: Complete data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Psoriatic Arthritis | Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision | 3 score on a scale |
Secondary
Number of Patients Undergoing Reduction of Therapy
Treatment reduction definition includes decrease in dose, frequency, change in route, stopping medication
Time frame: During the consultation visit (around 30-60 mins)
Population: Full population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Psoriatic Arthritis | Number of Patients Undergoing Reduction of Therapy | 22 Participants |