The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis
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|ClinicalTrials.gov Identifier: NCT02655640|
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : August 4, 2017
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|Condition or disease||Intervention/treatment|
|Lupus Erythematosus, Systemic Scleroderma, Systemic||Other: Questionnaires|
This is a single center academic study at two timepoints with an interval of 12 months. The data collection includes demographic variables, patient-reported variables, clinical variables and healthcare professionals-reported variables. All SSc and SLE patients who meet the inclusion criteria and are monitored by the rheumatology consultation in the University Hospitals Leuven will be contacted to participate in the study. Patients will be informed of the purpose of the study and what is expected of them. If they agree to participate they will also be asked to sign the Informed Consent form to send together with the completed questionnaire by mail.
After the patient gives his/her agreement to participate his/ her GP and rheumatologist will be asked to fill out the Revised Illness Perception Questionnaire for Healthcare Professionals (IPQ-R HP). This is a questionnaire that measures the perception of the doctor about the disease condition of their patient.
Data will be collected and kept by the investigator for analysis after complete coding. The obtained data will be analyzed using statistical methods.
With this study the investigators want to give an answer on 4 research questions:
- Are there differences in perceptions between GP's and rheumatologists?
- What is the direction of the associations between the illness perceptions of the physicians and patients?
- What is the direction of the associations between the illness perceptions of a patient with SLE or SSc and psychological and physical functioning?
- What is the direction of the associations between the illness perceptions of the physician and the psychological and physical functioning of the patient?
|Study Type :||Observational|
|Actual Enrollment :||241 participants|
|Official Title:||The Impact of Illness Perceptions and Their Determinants on Health Related Outcomes in Patients With Systemic Lupus Erythematosus and Systemic Sclerosis|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Characteristics of patients with Systemic Lupus Erythematosus. No interventions will be administered. Patients will be asked to complete questionnaires.
Questionnaires will be provided to patients
Characteristics of patients with Systemic Sclerosis. No interventions will be administered. Patients will be asked to complete questionnaires.
Questionnaires will be provided to patients
- Anxiety [ Time Frame: 12 months ]Anxiety will be measured with the Hospital Anxiety and Depression Scale.
- Depression [ Time Frame: 12 months ]Depression will be measured with the Hospital Anxiety and Depression Scale.
- General Health Status [ Time Frame: 12 months ]General Health Status will be measured with the EuroQol 5 dimensions.
- Illness perceptions of the general practitioner of a particular patient with SLE or SSc [ Time Frame: 12 months ]This will be measured with the IPQ-R HP (revised Illness Perception Questionnaire for Healthcare Professionals)
- Illness perceptions of the rheumatologist of a particular patient with SLE or SSc [ Time Frame: 12 months ]This will be measured with the IPQ-R HP (revised Illness Perception Questionnaire for Healthcare Professionals)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Firstly a list will be created of all patients with lupus and systemic sclerosis who are in follow-up at the reumatology department in UZ Leuven. Afterwards all patients who fulfill the inclusion criteria will be selected. The patients who are included will be informed by mail and they will be asked to participate. When they agree for participating then they will be asked to complete an informed consent form.
Hereafter the general practitioner and rheumatologist will be contacted to complete the IPQ-R HP (an illness perception questionnaire for Healthcare professionals)
- Before participation the patient gives informed consent.
- The medical condition of the patient allows him/her to complete a questionnaire
- The patient does not have a severe psychiatric comorbidity
- The patient can complete questionnaires in Dutch
- no exclusion criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655640
|Principal Investigator:||Rene Westhovens, MD, PhD||UZ Leuven|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Universitaire Ziekenhuizen KU Leuven|
|Other Study ID Numbers:||
|First Posted:||January 14, 2016 Key Record Dates|
|Last Update Posted:||August 4, 2017|
|Last Verified:||September 2015|
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases