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AzTrials

Shoulder DiseaseC-PRONCT06435494

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

A study testing Systematic use of patient reported outcome measures in clinical work with the patients in people with Shoulder Disease and Shoulder Impingement, run by University Hospital, Gentofte, Copenhagen at 6 sites in Denmark.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
Systematic use of patient reported outcome measures in clinical work with the patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
6 sitesDenmark
Study dates
12 Aug 2024to 1 Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • shoulder pain with no acute trauma

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

Denmark6 sites

  • Privathospitalet Danmark

    Charlottenlund, 2920

  • Department of Physiotherapy, Univesity Hospital Gentofte

    Gentofte Municipality, Hellerup, 2900

  • Department of rehabilitation, Gentofte Kommune

    Hellerup, 2900

  • Division of shoulder and elbow surgery, Department of orthopaedics, Univesity Hospital Gentofte

    Hellerup, 2900

  • Genoptræning og Rehabilitering, Rødovre Kommune

    Rødovre Municipality, Rødovre, 2610

  • Mit Lægehus

    Rødovre Municipality, 2610

Other trials in Denmark

About this study

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

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.

Being tested
Systematic use of patient reported outcome measures in clinical work with the patients
Medical subject headings
Shoulder Impingement Syndrome, Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Systematic use of patient reported outcome measures in clinical work with the patientsOther

    Se description of the arms

Study groups in NCT06435494
Study groupRoleWhat they receive
InterventionExperimentalAll patients will be asked to complete a number of questionaires: EQ5D-5L, a study specific questionaire (designed specifically for this study) and a shoulder-disease-specific questionaire (the Oxford Shoulder Score). For patients in the intervention group, the results of the questionaires will be accessable for patient and health-care professionals and will be used to illustrate the problems, make a prognostic model for the specific patient based on previous PRO results from other patients and will be used in monitoring the treatment of the patient.
Receives: Other: Systematic use of patient reported outcome measures in clinical work with the patients
ControlNo interventionAll patients will be asked to complete a number of questionaires: EQ5D-5L, a study specific questionaire and a shoulder-disease-specific questionaire. For patients int he control group, this will be collected, but not accessed or used during the treatment of the patient. The data will be used in the final analyses of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment cost per change in life quality

    The treatment cost during the study period expressed as the cost per improvement in life quality, similar to the cost per QALY (quality adjusted life years). The total cost will be calculated from hospital contacts, physiotherapy sessions and primary healthcare contacts. The EQ5D-5L will be used as a generic life quality measure. The primary outcome for the intervention and control group will be compared.

    Measured: From inclusion time and the 2 following years.

Secondary outcomes (11)

  1. Treatment cost per change in life quality stratisfied according to the specific shoulder diagnosis

    The same as primary outcome, but stratified according to the specific shoulder diagnosis

    Measured: From inclusion time and the 2 following years

  2. Patient satisfaction with the treatment of their shoulder problem

    Measured by questionaire (specifically the question "are you satisfied with the treatment fo your shoulder so far"?

    Measured: From inclusion time and the 2 following years

  3. Number of patients treated with surgery

    To evaluate if any difference in referral to surgery occurs between the intervention group and the control group, and analyse if any reasons for a difference can be identified

    Measured: From inclusion time and the 2 following years

  4. Number of contacts with either the hospital or the family doctor due to problems with the treated shoulder

    To evaluate if any difference in medical contacts due to the treated shoulder occurs between the intervention and the control groups, and analyse if any reasons for a difference can be identified

    Measured: From inclusion time and the 2 following years

  5. Number and types of complications during the treatment of the shoulder problem

    To evaluate if any difference in complications in relation to the treatment of the shoulder occurs between the intervention and the control groups, and analyse if any reasons for a difference can be identified

    Measured: From inclusion time and the 2 following years

  6. For patients still working: Number and duration (measured in days) of any periods of sick-leave/unemployment due to the shoulder problem

    To evaluate if any difference in employment-status and/or sick-leave occurs between the intervention and the control groups, and analyse if any reasons for a difference can be identified

    Measured: From inclusion time and the 2 following years

  7. Development in the PRO score, represented by Oxford Shoulder Score, over time for each specific shoulder disease

    To evaluate the development of PRO scores during a treatment of the included shoulder diseases with regards to the different treatment options, to create a reference for future treatments of these patients

    Measured: From inclusion time and the 2 following years

  8. PRO score, represented by Oxford Shoulder Score, as predictors?

    To evaluate if a PRO score can differentiate patients with regards to who might benefit from specific treatment regimens/effect of treatments measured by PRO

    Measured: From inclusion time and the 2 following years

  9. If use of systematic PRO scores, represented by Oxford Shoulder Score, changes the referral-pattern between the involved sectors

    To evaluate if PRO scores has the potential to be used to screen patients before making a referral between sectors

    Measured: From inclusion time and the 2 following years

  10. Health professionals' assessments of history and usefulness of the prognosis tools developed for this study (the Database setup in Procordo).

    To evaluate if the involved professionals experience any gain in the use of the PRO scores in the daily treatment of the patients. This will be evaluated at every visit with the patient by a questionaire to the treating professionals.

    Measured: From inclusion time and the 2 following years

  11. Patient satisfaction with the PRO score system build in the Database system (Procordo)

    Satisfaction and qualitative assessment of history and prognosis tool (intervention group only). This will be investigated by questionaire in relation to the completion of the PROs every 3 month during the study period.

    Measured: From inclusion time and the 2 following years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2024
  2. Study start12 Aug 2024
  3. Primary completion1 Sep 2030 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients evaluated and treated for a degenerative shoulder disorder will be randomised into two groups before first evaluation. For the intervention group, Patient reported outcomes (PRO) will be a part of the evaluation and follow-up of treatment. In the control group, it will not. Evaluation with PRO will be conducted every 3 months for 2 years follow-up.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06435494
Sponsor's protocol ID
H-23039139
Acronym
C-PRO
Status last verified
Mar 2025
First submitted
16 May 2024
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 41382298

Questions about this trial

What is this clinical trial studying?

A study testing Systematic use of patient reported outcome measures in clinical work with the patients in people with Shoulder Disease and Shoulder Impingement, run by University Hospital, Gentofte, Copenhagen at 6 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment cost per change in life quality (time frame: From inclusion time and the 2 following years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06435494, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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