Outpatient Follow-up on Demand in Rheumatoid Arthritis
Patient-controlled Outpatient Follow-up on Demand for Patients With Rheumatoid Arthritis: a Two-year Randomized Trial
Studieoversikt
Detaljert beskrivelse
A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. At baseline, patients were randomized electronically with stratification according to biologic and non-biologic treatment to the open outpatient clinic programme, or usual care. Patients were evaluated at baseline, year 1 and 2, including assessment of disease activity (DAS-28), blood tests, bone erosions on plain radiographs of hands and feet, and patient reported outcome measures.
The objective of the study was to compare an outpatient system for Danish RA patients based on patient self-controlled outpatient follow up on demand, Open Outpatient Clinic Programme with traditional scheduled routine follow-up regarding patient satisfaction and effect on traditional disease markers.
The Danish National Patient Registry (DANBIO) was used to identify eligible patients with RA. At pre-planned routine visits with the rheumatologist, identified patients were screened according to inclusion and exclusion criteria.
The intervention group had no scheduled appointments at the outpatient clinic, but they could book acute appointments with their contact rheumatologist within 5 days or less whenever they deemed it necessary. They also had access to nurse-led consultations without pre-booked appointments and to a nurse-led telephone helpline
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Copenhagen
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Hellerup, Copenhagen, Danmark, 2900
- University Hospital Gentofte
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
RA. Disease duration of at least 1 year.
Exclusion Criteria:
Patients treated with monthly intravenous biological medicine
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Open outpatient clinic programme (OOCP)
OOCP patients had no scheduled appointments but were allowed acute appointments with their rheumatologist, and had access to nurse-led consultations and telephone helpline.
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Ingen inngripen: Traditional scheduled routine follow up (TSRF)
Appointments for the TSRF group were scheduled according to routine procedures.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Visual analogue Scale (VAS) Patient satisfaction
Tidsramme: 2 years
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Patient reported outcome which assess overall how satisfied the patient is regarding the management of their rheumatoid arthritis in the hospital setting.
Patient satisfaction is scored on a visual analogue scale (VAS).
Minimum score is 0 (worst), and maximum score 100 (best).
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2 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Disease activity score in 28 joints (DAS28)
Tidsramme: 2 years
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DAS28 is a measure of disease activity in rheumatoid arthritis.
To calculate the DAS28 we counted the number of swollen joints and tender joints (out of the 28), measured C reactive protein (CRP) and assessed the patients 'global assessment of health' (indicated on a visual analogue scale from 0 (best) to 100 (worst)
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2 years
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Radiographic progression
Tidsramme: 2 year
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Radiographs of hands and feet were compared between baseline and follow-up, regarding development of structural changes, including bone erosions.
A musculoskeletal radiologist evaluated whether erosive development or progression was present.
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2 year
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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Annette Hansen, University Hospital Gentofte
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Protokol-38787-v1-08072013
Plan for individuelle deltakerdata (IPD)
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