Medication Adherence in Psoriatic Arthritis

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Other: Disease activity in psoriatic arthritis (DAPSA); Other: Compliance-Questionnaire-Rheumatology (CQR); Other: The Brief Illness Perception Questionnaire (BIPQ); Other: The Beliefs About Medicines Questionnaire (BMQ); Other: Hospital Anxiety and Depression Scale (HADS); Other: The Psoriatic Arthritis Quality of Life (PsAQoL)

• Registration Number: NCT05223062
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

Psoriatic arthritis (PsA) is a chronic multisystemic disease requiring ordinary doctor visits and an adherence to medication. Evaluating the parameters affecting the medication adherence is essential for the efficacy of the treatment. To our knowledge no study has ever evaluated the factors affecting the medication adherence in patients with PsA so far.

Detailed Description

Psoriatic arthritis (PsA) is a multisystemic disease requiring ordinary doctor visits and an adherence to medication. Due to its chronic nature treatment regimens lasts for the lifetime and that may affect the efficacy of the treatment. Although treatment with drugs is a biological intervention, medication adherence and eliminating the factors affecting it seems essential for treatment efficacy. To our knowledge no study has ever evaluated the factors affecting the medication adherence in patients with PsA so far. Our aim in this study is to evaluate the factors affecting the medication adherence in patients with PsA.

Study Timeline

• Study First Submitted: 2022-01-23
• Study First Submitted QC: 2022-01-23
• Study First Posted: 2022-02-03
• Study Start: 2022-02-18
• Status Verified: 2022-08
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-15
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosed with PsA according to CASPAR criteria
• Administering PsA medication for at least 6 moths
• Aged ≥18

Exclusion Criteria

• Not having enough cognitive functions to understand and answer the questionnaires
• Having a psychiatric disorder
• Having a severe comorbidity (e.g. malignancy, stroke)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psoriatic arthritis	Hospital Anxiety and Depression Scale (HADS)	Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).
Psoriatic arthritis	Disease activity in psoriatic arthritis (DAPSA)	Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).
Psoriatic arthritis	Compliance-Questionnaire-Rheumatology (CQR)	Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).
Psoriatic arthritis	The Psoriatic Arthritis Quality of Life (PsAQoL)	Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).
Psoriatic arthritis	The Brief Illness Perception Questionnaire (BIPQ)	Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).
Psoriatic arthritis	The Beliefs About Medicines Questionnaire (BMQ)	Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	1 day	Hospital Anxiety and Depression Scale (HADS) determines the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
The Brief Illness Perception Questionnaire (BIPQ)	1 day	The Brief Illness Perception Questionnaire (BIPQ) is a questionnaire that assesses a number of beliefs about illness which are thought to be related to coping and help-seeking behavior. Each item is scored between 0 and 10. Maximum total score is 80. Higher scores represents that the patient has a concerned perception of illness.
Disease activity in psoriatic arthritis (DAPSA)	1 day	The score of Disease activity in psoriatic arthritis (DAPSA) provides a continuous score of arthritis activity and has validated cut points for remission (\< 4) and low disease activity (\< 14). Higher scores represent a worse outcome.
Compliance-Questionnaire-Rheumatology (CQR)	1 day	The CQR is a self-administered questionnaire that was developed with the aim of correctly identifying patients that were classified as "low" adherers (taking \<80% of their medication correctly). The four point Likert answering scale ranges from; "Definitely don't agree" (scored 1) to "Definitely agree" (scored 4) with lower scores indicating lower levels of adherence. Total score is between 0 and 100.
The Beliefs About Medicines Questionnaire (BMQ)	1 day	he Beliefs About Medicines Questionnaire (BMQ) is a tool for evaluating people's beliefs about medicines. The BMQ comprises two sections: the BMQ-Specific which assesses representations of medication prescribed for personal use and the BMQ-General which assesses beliefs about medicines in general. It has a total of 18 questions scored with a 5-point Likert scale. Higher scores represent more powerful beliefs. Total score ranges from 4 to 20
The Psoriatic Arthritis Quality of Life (PsAQoL)	1 day	The Psoriatic Arthritis Quality of Life (PsAQoL) measure is a disease specific patient-reported outcome measure which measures the effect that psoriatic arthritis has on a patient's quality of life. It is a self-administered, 20-item questionnaire that takes about three minutes to complete. The answers are restricted to true or false.A high score on the PsAQoL indicates a lower quality of life. Total score is between 0 and 20.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey