Medication Adherence in Psoriatic Arthritis
Self-Reported Medication Adherence in Patients With Psoriatic Arthritis: Influence of Illness Perception and Medication Beliefs
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2022
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedStudy Start
First participant enrolled
February 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2022
CompletedAugust 29, 2022
August 1, 2022
6 months
January 23, 2022
August 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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
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
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
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
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
Study Arms (1)
Psoriatic arthritis
Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).
Interventions
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).
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) 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) 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) 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) 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.
Eligibility Criteria
Patients diagnosed with psoriatic arthritis having medication for at least 6 months
You may qualify if:
- Diagnosed with PsA according to CASPAR criteria
- Administering PsA medication for at least 6 moths
- Aged ≥18
You may not qualify if:
- Not having enough cognitive functions to understand and answer the questionnaires
- Having a psychiatric disorder
- Having a severe comorbidity (e.g. malignancy, stroke)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, Fatih, 34093, Turkey (Türkiye)
Related 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.
PMID: 26083391BACKGROUNDTolu S, Rezvani A, Karacan I, Bugdayci D, Kucuk HC, Bucak OF, 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.
PMID: 33758806BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2022
First Posted
February 3, 2022
Study Start
February 18, 2022
Primary Completion
August 15, 2022
Study Completion
August 15, 2022
Last Updated
August 29, 2022
Record last verified: 2022-08