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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 Leuven

Tracking Information
First Submitted Date December 1, 2015
First Posted Date January 14, 2016
Last Update Posted Date August 4, 2017
Study Start Date October 2015
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2016)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 11, 2016)
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis
Official Title The Impact of Illness Perceptions and Their Determinants on Health Related Outcomes in Patients With Systemic Lupus Erythematosus and Systemic Sclerosis
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?
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)

Condition
  • Lupus Erythematosus, Systemic
  • Scleroderma, Systemic
Intervention Other: Questionnaires
Questionnaires will be provided to patients
Study Groups/Cohorts
  • Lupus
    Characteristics of patients with Systemic Lupus Erythematosus. No interventions will be administered. Patients will be asked to complete questionnaires.
    Intervention: Other: Questionnaires
  • Scleroderma
    Characteristics of patients with Systemic Sclerosis. No interventions will be administered. Patients will be asked to complete questionnaires.
    Intervention: Other: Questionnaires
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 3, 2017)
241
Original Estimated Enrollment
 (submitted: January 11, 2016)
200
Actual Study Completion Date March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02655640
Other Study ID Numbers S58458
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor Universitaire Ziekenhuizen Leuven
Collaborators Not Provided
Investigators
Principal Investigator: Rene Westhovens, MD, PhD UZ Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date September 2015