Perception of DiseaseNCT04685187
Perception of Illness Turkish Validity and Reliability Study
An observational study of Perception of Disease, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
In chronic diseases such as rheumatic diseases, it is important to direct the treatment of the disease and to evaluate the disease perception in terms of the course of the disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perception of Disease
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 31 May 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid Arthritis, Spondyloarthropathies, Fibromyalgia, Reactive Arthritis, Sjögren Syndrome, Systemic Lupus Erythematosus
Who may be able to join
- Volunteer.
- To be diagnosed with any of the rheumatic diseases (Rheumatoid Arthritis, Spondyloarthropathies, Fibromyalgia, Reactive Arthritis, Sjögren Syndrome, Systemic Lupus Erythematosus) by a specialist.
Who cannot join
- Being diagnosed with a chronic disease other than rheumatic disease that requires regular medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability Study of Turkish Adaptation of The Disease Perception Scale in Rheumatic Diseases
In chronic diseases such as rheumatic diseases, it is important to direct the treatment of the disease and to evaluate the disease perception in terms of the course of the disease. As a result of this study, this questionnaire, which will help us gain information about the perception of the disease specific to rheumatic diseases, will be translated into Turkish.
Read the detailed description
Disease perception is the cognitive aspect of the disease state. Although they experience the same disease in a certain period of their lives, the methods of meeting the disease and coping with the disease differ. Patients try to explain their illnesses in the light of their personal experiences, knowledge, values, beliefs and needs. People create cognitive models to explain and predict events in the outside world. Patients also develop similar patterns of symptoms of transient or long-term disease. Leventhal et al. suggested that patients formed their own coping mechanisms with these cognitive models and developed the self-regulation theory. According to this theory, people create schemas about illness and life-threatening situations in their minds with the information presented to them from concrete and abstract sources. These cognitive models also include beliefs about treatment and control of the condition.
The World Health Organization (WHO) has classified more than 200 musculoskeletal diseases, the most common being rheumatoid arthritis and osteoarthritis. The biopsychosocial model has been drawing attention in rheumatological rehabilitation in recent years. This model acknowledges that the experiences and symptoms of the disease are affected by biological, psychological and social factors. The dysfunction is not only related to the severity of the disease, but also to how the disease is perceived. The patient's beliefs and perceptions about his illness show how the illness affects him both physically and emotionally. Disease perception is based not only on symptoms but also on disease-related consequences, concerns, and past illness experiences of the patient. Recent studies emphasize the importance of disease perception in explaining the difference in treatment outcomes in chronic diseases, including rheumatic diseases.
It was planned to determine the validity and reliability of the Disease Perception Scale in Rheumatic Diseases due to the importance of treatment in rheumatic diseases and the evaluation of disease perception in terms of the course of the disease.
- Conditions
- Perception of Disease
- Keywords
- rheumatic diseases, perception of illness
- Medical subject headings
- Rheumatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Health Assessment Questionnaire (HAQ)
HAQ has sub-sections that evaluate the inadequacy index (20 questions), pain (one question) and global health status (one question). The last week is questioned in the survey.There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2.
Measured: The first test is made when the patient is directed by the physician. Seventh day after test, re-test is made. For test-retest, the questionnaire will be repeated 7 days apart.
2) Nottingham Health Profile
Nottingham Health Profile (NHP) is a measurement tool that evaluates the health problems of individuals and how these problems affect their daily activities.The questionnaire is divided into two parts. The first parts comprises 38 questions in six categories: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. This first section is weighted to reflect how severe an impact the respondent thinks their health is having on the above areas of life. The second part of the NHP is made up of seven statements about areas of life that are commonly affected by health: paid employment, jobs around the house, social life, personal relationships, sex life, hobbies and interests, and holidays. Scores on the NHP can range from 0 i.e. no distress to 100 i.e severe distress.
Measured: The first test is made when the patient is directed by the physician. Seventh day after test, re-test is made. For test-retest, the questionnaire will be repeated 7 days apart.
Rheumatic Disease Illness Perception Questionnaire
It is a questionnaire consisting of 11 questions that evaluates the cognitive and emotional perception of the disease in individuals with rheumatic disease. The cause and consequences of the disease, the extent to which the patient understands his / her illness, and the emotional changes in the course of the disease and the disease are questioned.
Measured: The first test is made when the patient is directed by the physician. Seventh day after test, re-test is made. For test-retest, the questionnaire will be repeated 7 days apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Mar 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perception of DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University, Ondokuz Mayıs University, Izmir Katip Celebi University
- Responsible party
- Principal investigator, MİNE PEKESEN KURTÇA, Pamukkale University
- Investigators
- BİLGE BAŞAKCI CALIK, Assoc. Prof., Study chair, PAMUKKALE UNIVERTSITYSABAHAT YAPRAK CETİN, Asst. Prof., Study chair, Akdeniz UniversityVELİ ÇOBANKARA, Prof.Dr., Study chair, Pamukkale UniversityAYŞE AYAN, Assoc.Prof., Study chair, ANTALYA EDUCATION RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685187
- Sponsor's protocol ID
- ONDOKUZMAYISU
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We would like to share study protocol and statistical analysis (SAP).
Publications
Llewellyn CD, McGurk M, Weinman J. Illness and treatment beliefs in head and neck cancer: is Leventhal's common sense model a useful framework for determining changes in outcomes over time? J Psychosom Res. 2007 Jul;63(1):17-26. doi: 10.1016/j.jpsychores.2007.01.013.
PubMed 17586334Petrie KJ, Weinman J. Why illness perceptions matter. Clin Med (Lond). 2006 Nov-Dec;6(6):536-9. doi: 10.7861/clinmedicine.6-6-536. No abstract available.
PubMed 17228551Lochting I, Fjerstad E, Garratt AM. Illness perceptions in patients receiving rheumatology rehabilitation: association with health and outcomes at 12 months. BMC Musculoskelet Disord. 2013 Jan 16;14:28. doi: 10.1186/1471-2474-14-28.
PubMed 23324450
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability Study of Turkish Adaptation of The Disease Perception Scale in Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT04685187
- Acronym / sponsor ID
- ONDOKUZMAYISU
- Conditions
- Perception of Disease
- Keywords
- rheumatic diseases, perception of illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Collaborators
- Akdeniz University, Ondokuz Mayıs University, Izmir Katip Celebi University
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 28 Dec 2020 (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.
In chronic diseases such as rheumatic diseases, it is important to direct the treatment of the disease and to evaluate the disease perception in terms of the course of the disease. As a result of this study, this questionnaire, which will help us gain information about the perception of the disease specific to rheumatic diseases, will be translated into Turkish.
Detailed description
Disease perception is the cognitive aspect of the disease state. Although they experience the same disease in a certain period of their lives, the methods of meeting the disease and coping with the disease differ. Patients try to explain their illnesses in the light of their personal experiences, knowledge, values, beliefs and needs. People create cognitive models to explain and predict events in the outside world. Patients also develop similar patterns of symptoms of transient or long-term disease. Leventhal et al. suggested that patients formed their own coping mechanisms with these cognitive models and developed the self-regulation theory. According to this theory, people create schemas about illness and life-threatening situations in their minds with the information presented to them from concrete and abstract sources. These cognitive models also include beliefs about treatment and control of the condition.
The World Health Organization (WHO) has classified more than 200 musculoskeletal diseases, the most common being rheumatoid arthritis and osteoarthritis. The biopsychosocial model has been drawing attention in rheumatological rehabilitation in recent years. This model acknowledges that the experiences and symptoms of the disease are affected by biological, psychological and social factors. The dysfunction is not only related to the severity of the disease, but also to how the disease is perceived. The patient's beliefs and perceptions about his illness show how the illness affects him both physically and emotionally. Disease perception is based not only on symptoms but also on disease-related consequences, concerns, and past illness experiences of the patient. Recent studies emphasize the importance of disease perception in explaining the difference in treatment outcomes in chronic diseases, including rheumatic diseases.
It was planned to determine the validity and reliability of the Disease Perception Scale in Rheumatic Diseases due to the importance of treatment in rheumatic diseases and the evaluation of disease perception in terms of the course of the disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid Arthritis, Spondyloarthropathies, Fibromyalgia, Reactive Arthritis, Sjögren Syndrome, Systemic Lupus Erythematosus
Key inclusion criteria (2 listed)
- Volunteer.
- To be diagnosed with any of the rheumatic diseases (Rheumatoid Arthritis, Spondyloarthropathies, Fibromyalgia, Reactive Arthritis, Sjögren Syndrome, Systemic Lupus Erythematosus) by a specialist.
Key exclusion criteria (1 listed)
- Being diagnosed with a chronic disease other than rheumatic disease that requires regular medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1) Health Assessment Questionnaire (HAQ)
Time frame: The first test is made when the patient is directed by the physician. Seventh day after test, re-test is made. For test-retest, the questionnaire will be repeated 7 days apart.
HAQ has sub-sections that evaluate the inadequacy index (20 questions), pain (one question) and global health status (one question). The last week is questioned in the survey.There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2.
2) Nottingham Health Profile
Time frame: The first test is made when the patient is directed by the physician. Seventh day after test, re-test is made. For test-retest, the questionnaire will be repeated 7 days apart.
Nottingham Health Profile (NHP) is a measurement tool that evaluates the health problems of individuals and how these problems affect their daily activities.The questionnaire is divided into two parts. The first parts comprises 38 questions in six categories: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. This first section is weighted to reflect how severe an impact the respondent thinks their health is having on the above areas of life. The second part of the NHP is made up of seven statements about areas of life that are commonly affected by health: paid employment, jobs around the house, social life, personal relationships, sex life, hobbies and interests, and holidays. Scores on the NHP can range from 0 i.e. no distress to 100 i.e severe distress.
Rheumatic Disease Illness Perception Questionnaire
Time frame: The first test is made when the patient is directed by the physician. Seventh day after test, re-test is made. For test-retest, the questionnaire will be repeated 7 days apart.
It is a questionnaire consisting of 11 questions that evaluates the cognitive and emotional perception of the disease in individuals with rheumatic disease. The cause and consequences of the disease, the extent to which the patient understands his / her illness, and the emotional changes in the course of the disease and the disease are questioned.
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 28 Dec 2020.
- Background: PubMed 17586334Llewellyn CD, McGurk M, Weinman J. Illness and treatment beliefs in head and neck cancer: is Leventhal's common sense model a useful framework for determining changes in outcomes over time? J Psychosom Res. 2007 Jul;63(1):17-26. doi: 10.1016/j.jpsychores.2007.01.013.
- Background: PubMed 17228551Petrie KJ, Weinman J. Why illness perceptions matter. Clin Med (Lond). 2006 Nov-Dec;6(6):536-9. doi: 10.7861/clinmedicine.6-6-536. No abstract available.
- Background: PubMed 23324450Lochting I, Fjerstad E, Garratt AM. Illness perceptions in patients receiving rheumatology rehabilitation: association with health and outcomes at 12 months. BMC Musculoskelet Disord. 2013 Jan 16;14:28. doi: 10.1186/1471-2474-14-28.
- Individual participant dataSharing planned: No. We would like to share study protocol and statistical analysis (SAP).
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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.
BİLGE BAŞAKCI CALIK, Assoc. Prof. study chair
PAMUKKALE UNIVERTSITY
SABAHAT YAPRAK CETİN, Asst. Prof. study chair
Akdeniz University
VELİ ÇOBANKARA, Prof.Dr. study chair
Pamukkale University
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 Perception of Disease, run by Pamukkale 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 2 inclusion and 1 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 28 Dec 2020. 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?
1) Health Assessment Questionnaire (HAQ) (time frame: The first test is made when the patient is directed by the physician. Seventh day after test, re-test is made. For test-retest, the questionnaire will be repeated 7 days apart.). The study lists 3 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 NCT04685187, which also lists 3 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 28 Dec 2020; AzTrials last refreshed its copy on 29 Oct 2026.