- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02655640
The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis
The Impact of Illness Perceptions and Their Determinants on Health Related Outcomes in Patients With Systemic Lupus Erythematosus and Systemic Sclerosis
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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)
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- no exclusion criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lupus
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
|
Scleroderma
Characteristics of patients with Systemic Sclerosis.
No interventions will be administered.
Patients will be asked to complete questionnaires.
|
Questionnaires will be provided to patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: 12 months
|
Anxiety will be measured with the Hospital Anxiety and Depression Scale.
|
12 months
|
Depression
Time Frame: 12 months
|
Depression will be measured with the Hospital Anxiety and Depression Scale.
|
12 months
|
General Health Status
Time Frame: 12 months
|
General Health Status will be measured with the EuroQol 5 dimensions.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
12 months
|
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)
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rene Westhovens, MD, PhD, UZ Leuven
Publications and helpful links
General Publications
- Petrie KJ, Jago LA, Devcich DA. The role of illness perceptions in patients with medical conditions. Curr Opin Psychiatry. 2007 Mar;20(2):163-7. doi: 10.1097/YCO.0b013e328014a871.
- 2. Broadbent E. Illness perceptions and health: innovations and clinical applications. Soc Personal Psychol Compass 2010, 4(4):256-266.
- Leventhal, H, Meyer D, Nerenz D. The common-sense representation of illness danger. In S. Rachman (Ed.), Medical psychology 1980, Vol. 2: pp. 7-30. New York: Pergamon.
- Lau RR, Bernard TM, Hartman KA. Further explorations of common-sense representations of common illnesses. Health Psychol. 1989;8(2):195-219. doi: 10.1037//0278-6133.8.2.195.
- Moss-Morris R, Weinman J, Petrie KJ, Horne R, Cameron LD, Buick D. The Revised Illness Perception Questionnaire (IPQ-R). Psychol Health 2002, 17(1):1-16.
- Benyamini, Y. Health and illness perceptions. In H. Friedman (Ed.), The oxford handbook of health psychology 2011, pp. 281-314. New York: Oxford University Press.
- Petrie KJ, Weinman J. Patients' perception of their illness: the dynamo of volition in health care. Curr Dir Psychol Sci 2012, 21(1):60-65
- Arat S, Verschueren P, De Langhe E, Smith V, Vanthuyne M, Diya L, Van den Heede K, Blockmans D, De Keyser F, Houssiau FA, Westhovens R. The association of illness perceptions with physical and mental health in systemic sclerosis patients: an exploratory study. Musculoskeletal Care. 2012 Mar;10(1):18-28. doi: 10.1002/msc.223. Epub 2011 Nov 11.
- Daleboudt GM, Broadbent E, McQueen F, Kaptein AA. Intentional and unintentional treatment nonadherence in patients with systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2011 Mar;63(3):342-50. doi: 10.1002/acr.20411. Epub 2010 Nov 30.
- Daleboudt GM, Broadbent E, McQueen F, Kaptein AA. The impact of illness perceptions on sexual functioning in patients with systemic lupus erythematosus. J Psychosom Res. 2013 Mar;74(3):260-4. doi: 10.1016/j.jpsychores.2012.11.004. Epub 2012 Nov 21.
- Arat S, Rassart J, Moons P, Luyckx K, Vandenberghe J, Westhovens R. Prospective associations between illness perceptions and health outcomes in patients with systemic sclerosis and systemic lupus erythematosus: a cross-lagged analysis. Rheumatol Adv Pract. 2018 Mar 6;2(1):rky007. doi: 10.1093/rap/rky007. eCollection 2018.
- Arat S, Lenaerts JL, De Langhe E, Verschueren P, Moons P, Vandenberghe J, Taelman V, Westhovens R. Illness representations of systemic lupus erythematosus and systemic sclerosis: a comparison of patients, their rheumatologists and their general practitioners. Lupus Sci Med. 2017 Nov 14;4(1):e000232. doi: 10.1136/lupus-2017-000232. eCollection 2017.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S58458
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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