- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05455177
Change in Patient Reported Outcomes and Wish for Joint Surgery
Within-person Change in Patient-reported Outcomes and Their Association With the Wish to Undergo Joint Surgery During a Digital First-line Intervention for Osteoarthritis
Aim To investigate associations between within-person change in patient reported outcomes (PROMs) and wish for joint surgery during up to 12-month participation in a digital first-line intervention for knee and hip osteoarthritis (OA) comprising exercise and education.
Methods Retrospective observational registry data. All participants enrolling between June 1st 2018 and September 30th 2021 with follow-up data and with a change in their wish for surgery (dichotomous, becoming wishing or unwishing) were included. Analysed PROMS comprised pain (numeric rating scale (NRS), 0-10), 5 level EuroQol - 5-dimension (EQ5D-5L, 0.243-0.976), overall health (NRS, 0-10), activity impairment (NRS, 0-10), walking difficulties (yes/no), fear of movement (yes/no), function and quality of life subscales of Knee/Hip injury and Osteoarthritis Outcome Score 12 Items (KOOS-12/HOOS-12, both 0-100). To capture effects of changes in PROMs over time on probability of wish for surgery, the investigators used fixed effect (conditional) logistic regressions.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Skåne
-
Malmö, Skåne, Sverige
- Joint Academy
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of knee or hip osteoarthritis
- Date of enrolment between June 1st 2018 and September 30th 2021 (study period)
- Consent to the use of the data at the moment of enrolment (not withdrawn during the study period)
Exclusion Criteria:
- No follow-up data
- No change in wish for surgery (participants remained either wishing or not wishing to undergo surgery for the whole treatment period). This exclusion was due to the focus of the present study on within-person relationships between PROMs and wish for surgery. In this scenario, those with no change in their wish for surgery do not provide any information to the analysis.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Wish for surgery at baseline
Tidsramme: 0 months
|
Wish for surgery was monitored by asking the participants 'Are your symptoms so severe that you wish to undergo surgery in your [knee/hip]?' (dichotomous reply, yes/no).
|
0 months
|
|
Wish for surgery at 3 months
Tidsramme: 3 months
|
Wish for surgery was monitored by asking the participants 'Are your symptoms so severe that you wish to undergo surgery in your [knee/hip]?' (dichotomous reply, yes/no).
|
3 months
|
|
Wish for surgery at 6 months
Tidsramme: 6 months
|
Wish for surgery was monitored by asking the participants 'Are your symptoms so severe that you wish to undergo surgery in your [knee/hip]?' (dichotomous reply, yes/no).
|
6 months
|
|
Wish for surgery at 9 months
Tidsramme: 9 months
|
Wish for surgery was monitored by asking the participants 'Are your symptoms so severe that you wish to undergo surgery in your [knee/hip]?' (dichotomous reply, yes/no).
|
9 months
|
|
Wish for surgery at 12 months
Tidsramme: 12 months
|
Wish for surgery was monitored by asking the participants 'Are your symptoms so severe that you wish to undergo surgery in your [knee/hip]?' (dichotomous reply, yes/no).
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JAPROMS_w
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .