Comparing Use of Radiographs Versus Patient Empowerment (CURVE)

NCT05379127 | Unknown DMC

• 1 other identifier: 80-87600-98-19048
• Study Type: interventional
• Target: 812
• Locations: 1 country
• Sites: 23

Brief Summary

Objective: To evaluate the (cost-)effectiveness of a new patient-empowered follow up (FU) protocol in patients with Adolescent idiopathic Scoliosis (AIS) that is based on patient-reported outcome measures (PROMs), self-assessment tools and physical examination, which is compared to standard FU care by: 1) Effect evaluation, 2) Economic evaluation, 3) Implementation (process) evaluation. Study design: A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial \[PRPT\]). Study population: A total of 812 AIS patients (age 10-18 years) treated by the Dutch AIS Consortium, representing the scoliosis treatment centres in the Netherlands, will be included. Three subgroups of AIS patients are distinguished, which are monitored over two years:

1. 1.Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264)
2. 2.Post-brace treatment group (n=122 per arm; total n=244)
3. 3.Post-surgery group (n=152 per arm; total n=304)

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Scoliosis; Spine; Quality of Health Care; Cost-Benefit Analysis; Patient Participation; Radiology

Outcome Measures

Primary Outcomes (1)

• The proportion of radiographs that has led to treatment consequences

  the proportion will serve as an indication of the sensitivity of the new PE-FU protocol and standard FU protocol. The number of x-rays that has led to treatment will be divided by the total number of x-rays in each subgroup to calculate the primary outcome.

  24 months

Secondary Outcomes (12)

• The safety of the standard and the new protocol

  for pre-treatment and the post-brace group at 6, 12,18 and 24 months and for the postsurgery group at 3,12 and 24 months

• The specificity, negative predictive value and positive predictive value of the standard and new patient empowered follow up protocol.

  24 months

• The change in readiation exposure

  24 months

• Participants perspective: Numeric pain rating scale [NPRS 0-10]

  24 Months

• Participants perspective: condition-specific quality of life [SRS-22r]

  24 months

Study Arms (2)

Standard follow-up

OTHER

standard care during follow-up

Other: Standard follow-up

Patient-empowered follow-up

EXPERIMENTAL

Other: Patient-empowered follow up

Interventions

Patient-empowered follow up OTHER

The patient-empowered follow-up protocol consists of patient-reported outcome measures (PROMs), self-assessment tools and clinical assessment including physical examination. Radiographs will only be taken when progression of the scoliosis (curve progression) or postoperative complications are suspected based on test results and based on the criteria of so called 'sense of alarm'. Note: Sense of alarm ('niet pluis') is based on any deterioration on the above-mentioned PROMs, self-assessment tool, and clinician-based measurement instruments, which is a signal for the treating physician to consider when a radiograph is appropriate. Sense of alarm is described as any other concern by the orthopaedic surgeon, parent or child which warrants a radiograph. For both the Bunnell Scoliometer (clinical assessment tool) and the Scolioscoop (patient self-assessment tool) a threshold of ≥4° is used.

Patient-empowered follow-up

Standard follow-up OTHER

Routine radiographs are taken at each follow up visit during standard care (to detect possible curve progression or rule out postoperative complications).

Standard follow-up

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with adolescent idiopathic scoliosis (AIS).
• Age: 10-18 years old.
• Patients scheduled for follow up in one of the participating centres.
• Understanding of the Dutch language.
• Signed informed consent.
• Biplanar (Posterior-Anterior \[PA\] and Lateral) full-spine x-rays within the last 3 months.
• Specifically for the pre-treatment group:
• Girls aged ≤14 years (i.e. 10-14 years) and boys \<16 years (i.e. 10-15 years). These patients still have generally 2 years of remaining skeletal growth. Patients above this age with a curve below 25 degrees have a limited risk for progression
• Girls: pre-menarche up to 6 months post-menarche (to estimate end of growth)
• A primary coronal curve of 10-25 degree.
• Specifically for the post-brace group:
• Patients aged 12-18 years
• Within 3 months after termination of brace treatment
• Minimum of 6 months of brace treatment
• Specifically for the post-surgery group:

You may not qualify if:

• Patients with juvenile or infantile idiopathic scoliosis with the diagnosis of onset under the age of 10.
• Patients who are undergoing brace treatment. These patients are not included because of the need to monitor brace therapy with radiographs.
• Patients who have undergone previous spinal surgery and are undergoing revision surgery.
• Skeletally mature patients.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Trialbureau Zorgevaluatie Nederland: collaborator
• Nederlandse Orthopaedische Vereniging: collaborator
• Vereniging Scoliose Patiënten: collaborator
• Dutch Adolescent Idiopathic Scoliosis (AIS) Consortium: collaborator

Study Sites (23)

Isala

Zwolle, Drenthe, 8025AB, Netherlands

RECRUITING

Flevo ziekenhuis

Almere Stad, Flevoland, 1315RA, Netherlands

RECRUITING

Rijnstate

Arnhem, Gelderland, 6815 AD, Netherlands

NOT YET RECRUITING

St Jansdal

Harderwijk, Gelderland, 3844 DG, Netherlands

NOT YET RECRUITING

Maastricht UMC+

Maastricht, Limburg, 6229HX, Netherlands

RECRUITING

Viecuri

Venlo, Limburg, 5912, Netherlands

RECRUITING

Sint Maartenskliniek

Boxmeer, North Brabant, 5835 DV, Netherlands

RECRUITING

Amphia

Breda, North Brabant, 4818CK, Netherlands

RECRUITING

ETZ Elisabeth

Tilburg, North Brabant, 5022GC, Netherlands

NOT YET RECRUITING

Noordwestziekenhuis groep

Alkmaar, North Holland, 1815JD, Netherlands

NOT YET RECRUITING

OLVG

Amsterdam, North Holland, 1091AC, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Spaarne Gasthuis

Haarlem, North Holland, 2035 RC, Netherlands

RECRUITING

Dijklander

Hoorn, North Holland, 1624NP, Netherlands

NOT YET RECRUITING

Albert Schweitzer ziekenhuis

Dordrecht, South Holland, 3318 AT, Netherlands

RECRUITING

Groene Hart ziekenhuis

Gouda, South Holland, 2803HH, Netherlands

NOT YET RECRUITING

Leiden UMC

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Maasstad ziekenhuis

Rotterdam, South Holland, 3079 DZ, Netherlands

RECRUITING

Juliana kinderziekenhuis

The Hague, South Holland, 2545 AA, Netherlands

RECRUITING

Meander

Amersfoort, Utrecht, 3813TZ, Netherlands

RECRUITING

UMC Groningen

Groningen, 9713, Netherlands

RECRUITING

UMC Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Scoliosis; Patient Participation

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Miranda L van Hooff, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Marinus de Kleuver, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miranda L van Hooff, PhD

CONTACT

+31 24 361 3366; Miranda.vanHooff@radboudumc.nl

Jurre Baetsen, MSc

CONTACT

+31 6 55742308; Jurre.Baetsen@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial; PRPT). The PRPT consists of three separate randomized controlled trials (RCTs) including patients in the pre-treatment phase, post-brace phase or post-operative phase. Alongside the RCTs prospective preference cohorts are included for each treatment arm (patient empowered follow up \[PE-FU\] or standard follow up \[standard FU\]). In the preference cohorts all patients are monitored who are not willing (i.e. who have a preference for either the standard FU or PE-FU) to be randomized to either treatment arm, but who are still willing to participate in the study. By including preference cohorts the generalizability of study results is studied while the internal validity is assured. * Half of participants (n=406) allocation: randomized (RCT) * Half of participants (n=406) allocation: based on preference (preference cohorts)

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 18, 2022
• Study Start: July 17, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

NL (23)