Overview

This trial is active, not recruiting.

Conditions lupus erythematosus, systemic, scleroderma, systemic
Treatment questionnaires
Sponsor Universitaire Ziekenhuizen Leuven
Start date October 2015
End date March 2017
Trial size 200 participants
Trial identifier NCT02655640, S58458

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Characteristics of patients with Systemic Lupus Erythematosus. No interventions will be administered. Patients will be asked to complete questionnaires.
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
Questionnaires will be provided to patients

Primary Outcomes

Measure
Anxiety
time frame: 12 months
Depression
time frame: 12 months
General Health Status
time frame: 12 months

Secondary Outcomes

Measure
Illness perceptions of the general practitioner of a particular patient with SLE or SSc
time frame: 12 months
Illness perceptions of the rheumatologist of a particular patient with SLE or SSc
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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

Additional Information

Official title The Impact of Illness Perceptions and Their Determinants on Health Related Outcomes in Patients With Systemic Lupus Erythematosus and Systemic Sclerosis
Principal investigator Rene Westhovens, MD, PhD
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?
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.