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

Lupus Erythematosus, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655640
• Other study ID #: S58458
• Status: Completed
• Phase: N/A
• First received: December 1, 2015
• Last updated: August 3, 2017
• Start date: October 2015
• Est. completion date: March 2017

Study information

• Verified date: September 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

Other:
• Questionnaires
Questionnaires will be provided to patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

References & Publications (10)

2. Broadbent E. Illness perceptions and health: innovations and clinical applications. Soc Personal Psychol Compass 2010, 4(4):256-266.

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. — View Citation

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.

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. — View Citation

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. — View Citation

Lau RR, Bernard TM, Hartman KA. Further explorations of common-sense representations of common illnesses. Health Psychol. 1989;8(2):195-219. — View Citation

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.

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.

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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	Anxiety will be measured with the Hospital Anxiety and Depression Scale.	12 months
Primary	Depression	Depression will be measured with the Hospital Anxiety and Depression Scale.	12 months
Primary	General Health Status	General Health Status will be measured with the EuroQol 5 dimensions.	12 months
Secondary	Illness perceptions of the general practitioner of a particular patient with SLE or SSc	This will be measured with the IPQ-R HP (revised Illness Perception Questionnaire for Healthcare Professionals)	12 months
Secondary	Illness perceptions of the rheumatologist of a particular patient with SLE or SSc	This will be measured with the IPQ-R HP (revised Illness Perception Questionnaire for Healthcare Professionals)	12 months