Psoriatic ArthritisNCT05223062
Medication Adherence in Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Disease activity in psoriatic arthritis (DAPSA), Compliance-Questionnaire-Rheumatology (CQR) and The Brief Illness Perception Questionnaire (BIPQ)
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2022to 15 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with psoriatic arthritis having medication for at least 6 months
Who may be able to join
- Diagnosed with PsA according to CASPAR criteria
- Administering PsA medication for at least 6 moths
- Aged ≥18
Who cannot join
- Not having enough cognitive functions to understand and answer the questionnaires
- Having a psychiatric disorder
- Having a severe comorbidity (e.g. malignancy, stroke)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: Self-Reported Medication Adherence in Patients With Psoriatic Arthritis: Influence of Illness Perception and Medication Beliefs
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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Disease activity in psoriatic arthritis (DAPSA), Compliance-Questionnaire-Rheumatology (CQR), The Brief Illness Perception Questionnaire (BIPQ), The Beliefs About Medicines Questionnaire (BMQ), Hospital Anxiety and Depression Scale (HADS)
- Keywords
- Psoriatic Arthritis, Medication Adherence
- Medical subject headings
- Arthritis, Psoriatic, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease activity in psoriatic arthritis (DAPSA)Other
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)Other
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)Other
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)Other
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)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis | Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR). Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start18 Feb 2022
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223062
- Sponsor's protocol ID
- 2021/263
- Status last verified
- Aug 2022
- First submitted
- 23 Jan 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26083391Tolu 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.
PubMed 33758806
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Reported Medication Adherence in Patients With Psoriatic Arthritis: Influence of Illness Perception and Medication Beliefs
- ClinicalTrials.gov ID
- NCT05223062
- Acronym / sponsor ID
- 2021/263
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, Medication Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis | – | 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)Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with psoriatic arthritis having medication for at least 6 months
Key inclusion criteria (3 listed)
- Diagnosed with PsA according to CASPAR criteria
- Administering PsA medication for at least 6 moths
- Aged ≥18
Key exclusion criteria (3 listed)
- Not having enough cognitive functions to understand and answer the questionnaires
- Having a psychiatric disorder
- Having a severe comorbidity (e.g. malignancy, stroke)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Psoriatic arthritis |
| 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. | Other | Psoriatic arthritis |
| 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. | Other | Psoriatic arthritis |
| 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. | Other | Psoriatic arthritis |
| 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. | Other | Psoriatic arthritis |
| 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. | Other | Psoriatic arthritis |
Primary outcome
Disease activity in psoriatic arthritis (DAPSA)
Time frame: 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)
Time frame: 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 Brief Illness Perception Questionnaire (BIPQ)
Time frame: 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.
The Beliefs About Medicines Questionnaire (BMQ)
Time frame: 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
Hospital Anxiety and Depression Scale (HADS)
Time frame: 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 Psoriatic Arthritis Quality of Life (PsAQoL)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Background: PubMed 26083391Hromadkova 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.
- Background: PubMed 33758806Tolu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity in psoriatic arthritis (DAPSA) (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05223062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.