Medication Adherence in Psoriatic Arthritis

August 26, 2022 updated by: Bezmialem Vakif University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with psoriatic arthritis having medication for at least 6 months

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Psoriatic arthritis
Patients with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).
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).
Other: 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: 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: 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: 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: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
1 day
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
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/263

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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