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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04685187
Other study ID # ONDOKUZMAYISU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date May 31, 2020

Study information

Verified date December 2020
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date May 31, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Volunteer. - To be diagnosed with any of the rheumatic diseases (Rheumatoid Arthritis, Spondyloarthropathies, Fibromyalgia, Reactive Arthritis, Sjögren Syndrome, Systemic Lupus Erythematosus) by a specialist. Exclusion Criteria: - Being diagnosed with a chronic disease other than rheumatic disease that requires regular medication.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Mine Pekesen Kurtca Samsun

Sponsors (4)

Lead Sponsor Collaborator
Pamukkale University Akdeniz University, Izmir Katip Celebi University, Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

Løchting 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. — View Citation

Petrie KJ, Weinman J. Why illness perceptions matter. Clin Med (Lond). 2006 Nov-Dec;6(6):536-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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.
Primary 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. 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.
Primary 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. 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.