Change in Patient Reported Outcomes and Wish for Joint Surgery

July 25, 2022 updated by: Joint Academy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14018

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Malmö, Skåne, Sweden
        • Joint Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with osteoarthritis of the knee or hip ascertained by a clinicians who enrolled in a first-line digital intervention for OA including exercise and education.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
0 months
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 months
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).
6 months
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).
9 months
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joint Academy

Collaborators

Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JAPROMS_w

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Knee and Hip

Clinical Trials on Digital first-line intervention for osteoarthritis including exercise and education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe