Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04862520 |
| Other study ID # |
PDH4 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
August 2022 |
| Source |
Frederiksberg University Hospital |
| Contact |
Pernille H. Duhn, dr. |
| Phone |
+4538164158 |
| Email |
pernille.hurup.duhn[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Introduction:
The association between chronic widespread pain (CWP) and disability is well-established.
Although research support large inter-individual differences in functional outcomes, limited
studies are available on the socio-economic consequences of offering stratified treatment
based on prognostic factors. Identification of predictors of long-term functional outcomes
such as work disability as a critical consequence, could assist early and targeted
personalised interventions. The primary objective of this cohort study is to identify
prognostic factors for the primary endpoint work status (employed and working vs not working)
in patients with CWP assessed 3- years from baseline, i.e. at referral for specialist care.
Methods and analyses:
Data are collected at the diagnostic unit at Department of Rheumatology, Frederiksberg
Hospital. The first 1,000 patients >=18 years of age registered in a clinical research
database (DANFIB registry) with CWP either "employed and working" or "not working" will be
enrolled. Participants must meet the American College of Rheumatology (ACR) 1990 definition
of CWP, i.e. pain in all four body quadrants and axially for more than three months and are
additionally screened for fulfilment of criteria for FM. Clinical data and patient-reported
outcomes are collected at referral (baseline) through clinical assessment and electronic
questionnaires. Data on the primary endpoint work status at baseline and 3- years from
baseline will be extracted from the Integrated Labour Market Database, Statistics Denmark and
the nationwide Danish DREAM database. Prognostic factor analysis will be based on
multivariable logistic regression modelling with the dichotomous work status as dependent
variable.
Description:
By using prognostic factor research, the purpose is to understand and improve future outcomes
in patients with CWP. Identification of prognostic factors for long-term functional outcomes,
including work disability, could assist tailoring and timing the therapeutic decision for
specific patients and potentially optimise functional outcomes compared with offering
standardised (i.e. ignorant) intervention programs to patients with CWP.
The results from this cohort study are anticipated to contribute with relevant knowledge that
may be used to guide future intervention matching and delivery of stratified interventions
based on prognostic classification.
Study design:
The study is designed as a clinical cohort study enabling multivariable logistic regression
modelling of data from the large Danish DANFIB cohort of CWP patients with the primary aim
assessed after 3- years.
Setting:
Data collection takes place in a specialised clinical care setting at the diagnostic unit at
Department of Rheumatology, Frederiksberg Hospital. Here patients presenting with CWP, either
as their primary pain problem or secondary to other established rheumatic disease, have been
offered clinical assessment and screening for CWP since 1st of January 2018.
The electronic data collection is accessed via touchscreens and data are exported to a
designated clinical research database (the DANFIB registry). Data extracted from electronic
patient files, including findings at clinical examination (manual TP count), are also
integrated into the DANFIB registry. A protocol outlining the content and objectives of the
DANFIB registry can be accessed online.The DANFIB registry will serve as point of departure
for the current cohort study.
Participants:
The first 1,000 patients consecutively registered in the DANFIB registry with CWP independent
of working status. Participant inclusion is expected to be completed by December 2021.
Informed consent will be obtained for all participants when registered in the DANFIB
registry.
Data sources:
Baseline demographics, clinical characteristics and individual labour market status assessed
at baseline will be extracted from the DANFIB registry. Data on the primary endpoint work
status ("employed and working" or "not working") at baseline and again 3- years from baseline
will be extracted from the Integrated Laboure Market Database at Statistics Denmark and the
nationwide Danish DREAM database.
