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The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02655640
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen KU Leuven

Study Description
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Brief Summary:
This research project has the overall objective to investigate the direction of the associations between illness perceptions, their influencing factors and health-related outcomes. Moreover, the investigators want to look at the direction of the associations between illness perceptions and health related outcomes such as psychological and physical functioning in patients with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc). The investigators want to know whether the outcome variables anxiety, depression, physical (dis) functioning are influenced by illness perceptions or vice versa. Not only the patients' illness perceptions but also the illness perceptions of the General Practitioners (GP) and rheumatologists will be investigated. The researchers want to know if the doctors' perceptions have an impact on the physical and psychological functioning of the patient or vice versa. Much research in the field of illness perceptions is cross-sectional in nature which means that the direction of the relationships between variables is not known.

Condition or disease Intervention/treatment
Lupus Erythematosus, Systemic Scleroderma, Systemic Other: Questionnaires

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:

  1. Are there differences in perceptions between GP's and rheumatologists?
  2. What is the direction of the associations between the illness perceptions of the physicians and patients?
  3. What is the direction of the associations between the illness perceptions of a patient with SLE or SSc and psychological and physical functioning?
  4. What is the direction of the associations between the illness perceptions of the physician and the psychological and physical functioning of the patient?
Study Design
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Study Type : Observational
Actual Enrollment : 241 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Lupus
Characteristics of patients with Systemic Lupus Erythematosus. No interventions will be administered. Patients will be asked to complete questionnaires.
 Other: 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.
 Other: Questionnaires
Questionnaires will be provided to patients


Outcome Measures
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Primary Outcome Measures :
  1. Anxiety [ Time Frame: 12 months ]
    Anxiety will be measured with the Hospital Anxiety and Depression Scale.

  2. Depression [ Time Frame: 12 months ]
    Depression will be measured with the Hospital Anxiety and Depression Scale.

  3. General Health Status [ Time Frame: 12 months ]
    General Health Status will be measured with the EuroQol 5 dimensions.


Secondary Outcome Measures :
  1. 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)

  2. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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.


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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
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)

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
Investigators
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Principal Investigator: Rene Westhovens, MD, PhD UZ Leuven
More Information
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Publications:
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.
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT02655640    
Other Study ID Numbers: S58458
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: September 2015
Keywords provided by Universitaire Ziekenhuizen KU Leuven:
illness perceptions
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Skin Diseases