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Clinical Trials/NCT02655640
NCT02655640
Completed
Not Applicable

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

Universitaire Ziekenhuizen KU Leuven0 sites241 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lupus Erythematosus, Systemic
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
241
Primary Endpoint
Depression
Status
Completed
Last Updated
8 years ago

Overview

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.

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?

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
March 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.

Anxiety

Time Frame: 12 months

Anxiety will be measured with the Hospital Anxiety and Depression Scale.

Secondary Outcomes

  • Illness perceptions of the general practitioner of a particular patient with SLE or SSc(12 months)
  • Illness perceptions of the rheumatologist of a particular patient with SLE or SSc(12 months)

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