Trial Outcomes & Findings for AsseSSing Impact in pSoriatic Treatment (NCT NCT05171270)

NCT ID: NCT05171270

Last Updated: 2024-09-25

Results Overview

Treatment escalation definition includes increase in dose, frequency, change of route, new medication

• Recruitment status: COMPLETED
• Target enrollment: 503 participants
• Primary outcome timeframe: During the consultation visit (around 30-60 mins)
• Results posted on: 2024-09-25

Participant Flow

Recruitment in rheumatology outpatient clinics at sites between 12/07/2021 and 22/03/2022

Participant milestones

Measure	Psoriatic Arthritis Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire
Overall Study STARTED	503
Overall Study COMPLETED	503
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Psoriatic Arthritis n=503 Participants Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire
Age, Continuous	53.9 years STANDARD_DEVIATION 12.3 • n=503 Participants
Sex: Female, Male Female	247 Participants n=503 Participants
Sex: Female, Male Male	256 Participants n=503 Participants
Region of Enrollment United Kingdom	107 participants n=503 Participants
Region of Enrollment Italy	84 participants n=503 Participants
Region of Enrollment France	100 participants n=503 Participants
Region of Enrollment Germany	101 participants n=503 Participants
Region of Enrollment Spain	111 participants n=503 Participants

PRIMARY outcome

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

Population: Full population

Treatment escalation definition includes increase in dose, frequency, change of route, new medication

Outcome measures

Measure	Psoriatic Arthritis n=503 Participants Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire
Number of Patients Undergoing Treatment Escalation	160 Participants

SECONDARY outcome

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

Population: Full population

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

Outcome measures

Measure	Psoriatic Arthritis n=503 Participants Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire
Number of Patients Undergoing Reduction of Therapy	22 Participants

SECONDARY outcome

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

Population: Full population

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

Outcome measures

Measure	Psoriatic Arthritis n=503 Participants Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire
Mean PsAID-12 Scores	3.6 score on a scale Standard Deviation 2.5

SECONDARY outcome

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

Population: Full population

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

Outcome measures

Measure	Psoriatic Arthritis n=503 Participants Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire
Median CollaboRATE Score	9 score on a scale Interval 0.0 to 9.0

SECONDARY outcome

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

Population: Full population

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)

Outcome measures

Measure	Psoriatic Arthritis n=503 Participants Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire
Median Perceived Efficacy on Patient-physician Interaction Score (PEPPI)	23 score on a scale Interval 9.0 to 25.0

SECONDARY outcome

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

Population: Complete data

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.

Outcome measures

Measure	Psoriatic Arthritis n=503 Participants Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire
Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision	3 score on a scale Interval 1.0 to 5.0

Adverse Events

Psoriatic Arthritis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Laura Coates

University of Oxford

Phone: 07870257823

Email: laura.coates@ndorms.ox.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place