Medication Adherence in Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official title:

Self-Reported Medication Adherence in Patients With Psoriatic Arthritis: Influence of Illness Perception and Medication Beliefs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223062
• Other study ID #: 2021/263
• Status: Completed
• Start date: February 18, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2022
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Other:
• Disease activity in psoriatic arthritis (DAPSA)
DAPSA includes a 68/66 joint count summed with a patient global, patient pain score, and C- reactive protein level. The DAPSA provides a continuous score of arthritis activity and has validated cut points for remission (< 4) and low disease activity (< 14).
• Compliance-Questionnaire-Rheumatology (CQR)
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 Brief Illness Perception Questionnaire (BIPQ)
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.
• The Beliefs About Medicines Questionnaire (BMQ)
The 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.
• Hospital Anxiety and Depression Scale (HADS)
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 Psoriatic Arthritis Quality of Life (PsAQoL)
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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Hromadkova L, Soukup T, Vlcek J. Quality of life and drug compliance: their interrelationship in rheumatic patients. J Eval Clin Pract. 2015 Oct;21(5):919-24. doi: 10.1111/jep.12399. Epub 2015 Jun 17. — View Citation

Tolu S, Rezvani A, Karacan I, Bugdayci D, Küçük HC, Bucak ÖF, Aydin T. Self-Reported Medication Adherence in Patients With Ankylosing Spondylitis: The Role of Illness Perception and Medication Beliefs. Arch Rheumatol. 2020 Feb 7;35(4):495-505. doi: 10.46497/ArchRheumatol.2020.7732. eCollection 2020 Dec. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity in psoriatic arthritis (DAPSA)	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.	1 day
Primary	Compliance-Questionnaire-Rheumatology (CQR)	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.	1 day
Primary	The Brief Illness Perception Questionnaire (BIPQ)	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.	1 day
Primary	The Beliefs About Medicines Questionnaire (BMQ)	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	1 day
Primary	Hospital Anxiety and Depression Scale (HADS)	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.	1 day
Primary	The Psoriatic Arthritis Quality of Life (PsAQoL)	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.	1 day