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

• ClinicalTrials.gov Identifier: NCT02655640
• Recruitment Status: Completed
• First Posted: January 14, 2016
• Last Update Posted: August 4, 2017
• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Information provided by (Responsible Party): Universitaire Ziekenhuizen KU 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

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 *

• Petrie KJ, Jago LA, Devcich DA. The role of illness perceptions in patients with medical conditions. Curr Opin Psychiatry. 2007 Mar;20(2):163-7. doi: 10.1097/YCO.0b013e328014a871.
• 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.
• Lau RR, Bernard TM, Hartman KA. Further explorations of common-sense representations of common illnesses. Health Psychol. 1989;8(2):195-219. doi: 10.1037//0278-6133.8.2.195.
• 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
• Arat S, Verschueren P, De Langhe E, Smith V, Vanthuyne M, Diya L, Van den Heede K, Blockmans D, De Keyser F, Houssiau FA, Westhovens R. The association of illness perceptions with physical and mental health in systemic sclerosis patients: an exploratory study. Musculoskeletal Care. 2012 Mar;10(1):18-28. doi: 10.1002/msc.223. Epub 2011 Nov 11.
• Daleboudt GM, Broadbent E, McQueen F, Kaptein AA. Intentional and unintentional treatment nonadherence in patients with systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2011 Mar;63(3):342-50. doi: 10.1002/acr.20411. Epub 2010 Nov 30.
• Daleboudt GM, Broadbent E, McQueen F, Kaptein AA. The impact of illness perceptions on sexual functioning in patients with systemic lupus erythematosus. J Psychosom Res. 2013 Mar;74(3):260-4. doi: 10.1016/j.jpsychores.2012.11.004. Epub 2012 Nov 21.
• Arat S, Rassart J, Moons P, Luyckx K, Vandenberghe J, Westhovens R. Prospective associations between illness perceptions and health outcomes in patients with systemic sclerosis and systemic lupus erythematosus: a cross-lagged analysis. Rheumatol Adv Pract. 2018 Mar 6;2(1):rky007. doi: 10.1093/rap/rky007. eCollection 2018.
• Arat S, Lenaerts JL, De Langhe E, Verschueren P, Moons P, Vandenberghe J, Taelman V, Westhovens R. Illness representations of systemic lupus erythematosus and systemic sclerosis: a comparison of patients, their rheumatologists and their general practitioners. Lupus Sci Med. 2017 Nov 14;4(1):e000232. doi: 10.1136/lupus-2017-000232. eCollection 2017.

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

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
• Current Responsible Party: Universitaire Ziekenhuizen KU Leuven
• Original Responsible Party: Same as current
• Current Study Sponsor: Universitaire Ziekenhuizen KU Leuven
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rene Westhovens, MD, PhD; UZ Leuven

• PRS Account: Universitaire Ziekenhuizen KU Leuven
• Verification Date: September 2015