Lupus Erythematosus, SystemicNCT02655640
The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis
An observational study of Lupus Erythematosus, Systemic and Scleroderma, Systemic, run by Universitaire Ziekenhuizen KU Leuven.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lupus Erythematosus, Systemic, Scleroderma, Systemic
- What is being tested?
- Questionnaires
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- no exclusion criteria
About this study
Official title: The Impact of Illness Perceptions and Their Determinants on Health Related Outcomes in Patients With Systemic Lupus Erythematosus 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.
Read the 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:
- 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?
- Being tested
- Questionnaires
- Keywords
- illness perceptions
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaires will be provided to patients
| Study group | Role | What they receive |
|---|---|---|
| Lupus | Characteristics of patients with Systemic Lupus Erythematosus. No interventions will be administered. Patients will be asked to complete questionnaires. Receives: Other: Questionnaires | |
| Scleroderma | Characteristics of patients with Systemic Sclerosis. No interventions will be administered. Patients will be asked to complete questionnaires. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety will be measured with the Hospital Anxiety and Depression Scale.
Measured: 12 months
Depression
Depression will be measured with the Hospital Anxiety and Depression Scale.
Measured: 12 months
General Health Status
General Health Status will be measured with the EuroQol 5 dimensions.
Measured: 12 months
Secondary outcomes (2)
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)
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rene Westhovens, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655640
- Sponsor's protocol ID
- S58458
- Status last verified
- Sep 2015
- First submitted
- 1 Dec 2015
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 172789162. 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.
PubMed 2737174Moss-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.
PubMed 22076953Daleboudt 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.
PubMed 21120967Daleboudt 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.
PubMed 23438719Arat 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.
PubMed 31431956Arat 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.
PubMed 29177061
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Illness Perceptions and Their Determinants on Health Related Outcomes in Patients With Systemic Lupus Erythematosus and Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT02655640
- Acronym / sponsor ID
- S58458
- Keywords
- illness perceptions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lupus | – | Other: QuestionnairesCharacteristics of patients with Systemic Lupus Erythematosus. No interventions will be administered. Patients will be asked to complete questionnaires. |
| Scleroderma | – | Other: QuestionnairesCharacteristics of patients with Systemic Sclerosis. No interventions will be administered. Patients will be asked to complete questionnaires. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires will be provided to patients | Other | Lupus, Scleroderma |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Background: PubMed 17278916Petrie 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.
- Background2. Broadbent E. Illness perceptions and health: innovations and clinical applications. Soc Personal Psychol Compass 2010, 4(4):256-266.
- BackgroundLeventhal, 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.
- Background: PubMed 2737174Lau 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.
- BackgroundMoss-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.
- BackgroundBenyamini, Y. Health and illness perceptions. In H. Friedman (Ed.), The oxford handbook of health psychology 2011, pp. 281-314. New York: Oxford University Press.
- BackgroundPetrie KJ, Weinman J. Patients' perception of their illness: the dynamo of volition in health care. Curr Dir Psychol Sci 2012, 21(1):60-65
- Background: PubMed 22076953Arat 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.
- Background: PubMed 21120967Daleboudt 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.
- Background: PubMed 23438719Daleboudt 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.
- Derived from this study: PubMed 31431956Arat 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.
- Derived from this study: PubMed 29177061Arat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene Westhovens, MD, PhD principal investigator
UZ Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic and Scleroderma, Systemic, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655640, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.