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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06461000
Other study ID # EPI001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 12, 2024
Est. completion date June 12, 2029

Study information

Verified date June 2024
Source European Alliance of Associations in Rheumatology
Contact Coralie Signorell, PhD
Phone 0445751564
Email coralie.signorell@eular.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The EULAR Impact of RMDs Survey collects first-hand information about the impact of rheumatic and musculoskeletal diseases (RMDs) among patients across and beyond Europe. Through periodic questionnaires, patients will provide information about their healthcare situation, and how the disease affects their social and occupational lives. This data will be an important resource for researchers, healthcare professionals, and patients alike, providing valuable insights into the burden of disease and helping improve the overall care for people living with these conditions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date June 12, 2029
Est. primary completion date June 12, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18-year-old at time of baseline survey - Living in a EULAR country at time of baseline survey - Diagnosed with at least one RMD - Valid personal e-mail address - Being able to use an internet website Exclusion Criteria: - none

Study Design


Intervention

Other:
Survey
online survey for participants

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
European Alliance of Associations in Rheumatology

Outcome

Type Measure Description Time frame Safety issue
Primary General population description - country country of residence every 6 months for up to 5 years
Primary General population description - diagnosis diagnosis (name of the disease) every 6 months for up to 5 years
Primary General population description year of birth every 6 months for up to 5 years
Secondary Diagnosis history - physician treating the RMD Primary physician specialty treating the patient every 6 months for up to 5 years
Secondary Diagnosis history - outpatient care history number of medical appointments for the past 6 months every 6 months for up to 5 years
Secondary Diagnosis history - timeline waiting time for medical appointments and time spent in medical appointments every 6 months for up to 5 years
Secondary Diagnosis history - Inpatient care number of days of hospitalization during the past 6 months. every 6 months for up to 5 years
Secondary Non-pharmacological and pharmacological treatments. Names of medications taken by the patients (from a list) every 6 months for up to 5 years
Secondary Other chronic diseases diagnosis of chronic diseases other than RMD and medication taken for these conditions. every 6 months for up to 5 years
Secondary Disease burden - impact of disease Rheumatic Arthritis Impact of Disease (RAID) version 7 questionnaire every 6 months for up to 5 years
Secondary Disease burden - health assessment Health assessment questionnaire version 2 (HAQ2) every 6 months for up to 5 years
Secondary Disease burden - quality of life patient health questionnaire (PHQ-8) every 6 months for up to 5 years
Secondary Consequences on work and life work productivity and activity impairment questionnaire (WPAI), including total number of sick leave days due to RMD in the past 6 months. every 6 months for up to 5 years
Secondary Other barriers due to RMD impact on family, leisure, social and work activities (quality of life questionnaire) every 6 months for up to 5 years
Secondary Health care support from professionals (general questionnaire), satisfaction with care (scale, 1= low, 5 = high satisfaction) every 6 months for up to 5 years
Secondary Demographics - persons living with patient number of persons living in household every 6 months for up to 5 years
Secondary Demographics - professional status professional status every 6 months for up to 5 years
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