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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05455177
Enrollment
14018
Registered
2022-07-13
Start date
2018-06-01
Completion date
2021-09-30
Last updated
2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee and Hip

Keywords

osteoarthritis, exercise, wish for surgery, digital intervention, PROMs

Brief summary

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.

Interventions

OTHERDigital first-line intervention for osteoarthritis including exercise and education

The digital OA management programme was delivered by a smartphone application, including education and exercises based on a face-to-face osteoarthritis self-management programme provided nationwide in Sweden and designed according to national and international guidelines. Over 12 weeks, which is the recommended minimum duration of a self-management intervention for OA, a total of 163 exercise sessions and 31 educational sessions are provided.

Sponsors

Lund University
CollaboratorOTHER
Joint Academy
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

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.

Design outcomes

Primary

MeasureTime frameDescription
Wish for surgery at baseline0 monthsWish 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).
Wish for surgery at 3 months3 monthsWish 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).
Wish for surgery at 6 months6 monthsWish 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).
Wish for surgery at 9 months9 monthsWish 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).
Wish for surgery at 12 months12 monthsWish 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).

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026