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Enrolling by invitation NCT06435494

Cross-sectorial Use of Patient-Reported Outcomes in Chronic Degenerative Shoulder Conditions

No phase Interventional Shoulder Disease Shoulder Impingement Shoulder Osteoarthritis Shoulder Frozen

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Systematic use of patient reported outcome measures in clinical work with the patients.
Who it may be relevant to
Registry conditions: Shoulder Disease, Shoulder Impingement, Shoulder Osteoarthritis, Shoulder Frozen. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

C-PRO - The Effect of Cross-sectorial Use of Patient-Reported Outcomes for Patients With Chronic Degenerative Shoulder Conditions

Overview

This research project aims to test if systematic (extensive) use of patient-reported outcomes across treatment boundaries can 1. improve patients' and health professionals' understanding of individual patients' conditions and health changes, 2. improve indications for treatment, 3. strengthen patient empowerment, and 4. reduce patients' utilization of health services. The study will be performed in the particular context of patients with chronic degenerative conditions of the shoulder. These patients are characterized by contact with numerous health professionals from different health sectors, such as general practitioner, physiotherapists and surgical referral centres, which challenges coherence and communication for the individual treatment decisions. The research project will be performed as a randomized controlled trial (RCT) with a 1-year inclusion period and two years of follow-up.

Interventions

  • Other Systematic use of patient reported outcome measures in clinical work with the patients
    Se description of the arms

Primary outcome measures

  • Treatment cost per change in life quality [Time frame: From inclusion time and the 2 following years.]
Secondary outcome measures (11)
  • Treatment cost per change in life quality stratisfied according to the specific shoulder diagnosis [Time frame: From inclusion time and the 2 following years]
  • Patient satisfaction with the treatment of their shoulder problem [Time frame: From inclusion time and the 2 following years]
  • Number of patients treated with surgery [Time frame: From inclusion time and the 2 following years]
  • Number of contacts with either the hospital or the family doctor due to problems with the treated shoulder [Time frame: From inclusion time and the 2 following years]
  • Number and types of complications during the treatment of the shoulder problem [Time frame: From inclusion time and the 2 following years]
  • For patients still working: Number and duration (measured in days) of any periods of sick-leave/unemployment due to the shoulder problem [Time frame: From inclusion time and the 2 following years]
  • Development in the PRO score, represented by Oxford Shoulder Score, over time for each specific shoulder disease [Time frame: From inclusion time and the 2 following years]
  • PRO score, represented by Oxford Shoulder Score, as predictors? [Time frame: From inclusion time and the 2 following years]
  • If use of systematic PRO scores, represented by Oxford Shoulder Score, changes the referral-pattern between the involved sectors [Time frame: From inclusion time and the 2 following years]
  • Health professionals' assessments of history and usefulness of the prognosis tools developed for this study (the Database setup in Procordo). [Time frame: From inclusion time and the 2 following years]
  • Patient satisfaction with the PRO score system build in the Database system (Procordo) [Time frame: From inclusion time and the 2 following years]

Eligibility criteria

Inclusion criteria

  • shoulder pain with no acute trauma

Exclusion criteria

  • Age <18 years
  • Non-Danish citizenship
  • Unable to understand written or spoken Danish
  • Inability to master electronic means of communication and/or not having an electronic communication (E-boks)
  • Employee at participating centre or other relation to participating health professionals that might affect independent consent
  • Psychiatric conditions, mental conditions and substance abuse that might affect the ability to provide informed consent or responding to PROMs
  • Disseminated malignant condition, other serious medical conditions or other life crisis where the focus on a shoulder research project is unreasonable
  • Already included in the study with the contralateral shoulder

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Denmark · 6 centers
  • Department of Physiotherapy, Univesity Hospital Gentofte — Gentofte Municipality
  • Genoptræning og Rehabilitering, Rødovre Kommune — Rødovre Municipality
  • Privathospitalet Danmark — Charlottenlund
  • Department of rehabilitation, Gentofte Kommune — Hellerup
  • Division of shoulder and elbow surgery, Department of orthopaedics, Univesity Hospital Gen — Hellerup
  • Mit Lægehus — Rødovre Municipality

Publications

  • Nyholm AM, Esbensen BA, Westergaard CL, Kjellberg J, Juhl CB, Olsen BS, Odgaard A. Cross-sectoral use of Patient-Reported Outcomes (C-PRO)-the effect on the cost per improvement in quality of life for patients with chronic degenerative shoulder conditions-a protocol for a randomised controlled trial. Trials. 2025 Dec 12;27(1):47. doi: 10.1186/s13063-025-09329-0. PMID 41382298

Identifiers

NCT: NCT06435494 · H-23039139

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗