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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06435494
Other study ID # H-23039139
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date September 1, 2030

Study information

Verified date May 2024
Source University Hospital, Gentofte, Copenhagen
Contact Anne Marie Nyholm, MD, PhD
Phone +4538673391
Email anne.marie.nyholm.01@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date September 1, 2030
Est. primary completion date September 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Denmark Department of Physiotherapy, Univesity Hospital Gentofte Gentofte Hellerup
Denmark Department of rehabilitation, Gentofte Kommune Hellerup
Denmark Division of shoulder and elbow surgery, Department of orthopaedics, Univesity Hospital Gentofte Hellerup
Denmark Genoptræning og Rehabilitering, Rødovre Kommune Rødovre
Denmark Mit Lægehus Rødovre

Sponsors (8)

Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen Center for Rehabilitering og Forebyggelse, Gentofte Kommune, Denmark, Genoptræning og Rehabilitering, Rødovre Kommune, Denmark, Mit Lægehus, Rødovre, Denmark, Region Capital Denmark, Rigshospitalet, Denmark, The Novo Nordic Foundation, VIVE - The Danish Center for Social Science Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From inclusion time and the 2 following years.
Secondary 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 From inclusion time and the 2 following years
Secondary 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"? From inclusion time and the 2 following years
Secondary 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 From inclusion time and the 2 following years
Secondary 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 From inclusion time and the 2 following years
Secondary 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 From inclusion time and the 2 following years
Secondary 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 From inclusion time and the 2 following years
Secondary 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 From inclusion time and the 2 following years
Secondary 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 From inclusion time and the 2 following years
Secondary 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 From inclusion time and the 2 following years
Secondary 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. From inclusion time and the 2 following years
Secondary 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. From inclusion time and the 2 following years
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