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Completed

NCT Number: NCT02655640

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

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.

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Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

Questionnaires will be provided to patients

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 14, 2016
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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