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OpenTrials
Completed

NCT Number: NCT05455177

Change in Patient Reported Outcomes and Wish for Joint Surgery

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.

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Key information

Conditions

Osteoarthritis, Knee and Hip Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Joint Academy

Malmö, Skåne County, Sweden

Who can participate

Only the study team can determine whether someone qualifies for participation.

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  • Consent to the use of the data at the moment of enrolment (not withdrawn during the study period)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.

Treatment and study plan

Digital first-line intervention for osteoarthritis including exercise and education

Other

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.

Primary outcomes

  1. Wish for surgery at baseline

    Time frame: 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).

  2. Wish for surgery at 3 months

    Time frame: 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. Wish for surgery at 6 months

    Time frame: 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).

  4. Wish for surgery at 9 months

    Time frame: 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).

  5. Wish for surgery at 12 months

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Joint Academy

Industry

Collaborators

  • Lund University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2022
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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