Change in Patient Reported Outcomes and Wish for Joint Surgery

NCT05455177 | Completed

• 1 other identifier: JAPROMS_w
• Study Type: observational
• Target: 14,018
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee and Hip

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Wish for surgery at baseline

  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

  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

  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

  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

  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

Interventions

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• No follow-up data

Sponsors & Collaborators

• Joint Academy: lead
• Lund University: collaborator

Study Sites (1)

Joint Academy

Malmo, Skåne County, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 13, 2022
• Study Start: June 1, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)