Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337513
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-28
First Post:
2024-03-12
Brief Title:
Spondyloarthritis Inception Cohort of Southern Denmark
Sponsor:
The Danish Center for Expertise in Rheumatology
Organization:
The Danish Center for Expertise in Rheumatology
Study Overview
Official Title:
Spondyloarthritis Inception Cohort of Southern Denmark
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPINCODE
Brief Summary:
People with axial spondyloarthritis axSpA experience a diagnostic delay of 65 years in men and up to 88 years in women One of the reasons for the diagnostic delay seems to be limited awareness of the disease characteristics in the referring health care professionals in primary care By raising awareness about the disease the study aims at reducing the diagnostic delay and improving early treatment In addition to diagnostic and pharmacological treatment physical exercise and rehabilitation are recommended in people with axSpA In Denmark people with axSpA are only offered free of charge physiotherapy when the disease has progressed to a stage with radiographic changes of the spine even though people in the early stage of axSpA report a similar disease burden
The overall objective of Spondyloarthritis Inception Cohort of Southern Denmark SPINCODE is to set up an axSpA inception cohort among individuals with low back pain 3 months who are considered to be at risk for axSpA The investigators aim to learn more about the course of axSpA during the early stage of disease appropriately assess outcomes including novel imaging techniques and identify predictive outcomes Moreover the investigators want to test the effect of an outpatient physiotherapist-coordinated rehabilitation intervention in people suspected of having axSpA
The overall objective of Spondyloarthritis Inception Cohort of Southern Denmark SPINCODE is to set up an axSpA inception cohort among individuals with low back pain 3 months who are considered to be at risk for axSpA The investigators aim to learn more about the course of axSpA during the early stage of disease appropriately assess outcomes including novel imaging techniques and identify predictive outcomes Moreover the investigators want to test the effect of an outpatient physiotherapist-coordinated rehabilitation intervention in people suspected of having axSpA
Detailed Description:
Spondyloarthritis SpA affects 01-3 of the population in Denmark ie approximately 100000 individuals SpA encompasses among other diseases axial spondyloarthritis axSpA There is a diagnostic delay of 65 years in men and up to 88 years in women in people with axSpA and it may partly be due to a lack of awareness of possible SpA in the primary care sector Structured exercise is recommended for people with axSpA by international organisations Therefore information about exercise safety and physical activity guidance by physiotherapists PT are recommended At present most people with axSpA are not offered support from PTs or occupational therapists in rheumatology outpatient clinics in Denmark and not all see an outpatient rheumatology nurse for patient education and self-management support although this is recommended The importance of coherence in rehabilitation across all levels in the health care system has been highlighted by the World Health Organisation WHO To gain and maintain benefits from the interdisciplinary rehabilitative initiatives in the rheumatology clinics patients with axSpA need support in the transition from the rheumatology outpatient clinic to primary care to ensure long-term rehabilitation benefits In summary early referral and early rehabilitation in people with SpA are inadequate and need improvement
Aims
To set up an axSpA inception cohort among individuals with low back pain 3 months in the counties of Southern Jutland who are considered to be at risk for axSpA
To describe the epidemiology demographics clinical laboratory and imaging signatures in a population with low back pain suspected of axSpA and improve awareness about incipient axSpA
To test the feasibility of a novel outpatient interdisciplinary rehabilitation intervention for patients with low back pain suspected of SpA
To evaluate and compare the effect of a novel outpatient interdisciplinary rehabilitation intervention adjunct to pharmacological therapy for patients with suspected SpA by studying differences in pain fatigue mental and physical functioning work ability physical activity levels and quality of life among those with and without a definite axSpA diagnosis
Methods
The study consists of a medical part and a rehabilitation part The medical part is planned as a prospective observational single centre cohort study of consecutive patients with low back pain 3 months and 3 years symptom onset at age 18-45 years and suspected of axSpA referred from the Counties of Southern Jutland and followed at Danish Hospital for Rheumatic Diseases DHR for a consecutive period of two years In order to diagnose axSpA and to improve diagnostic accuracy there will be used novel imaging techniques like low-dose computed tomography ld-CT and dual energy computed tomography DECT in addition to standard of care magnetic resonance imaging MRI of the sacroiliac joints SIJ and spine
The rehabilitation design is developed in accordance with the Medical Research Councils framework for developing complex interventions The design will be tested in a feasibility study adapted as needed and planned to be tested in randomised controlled study RCT in addition to pharmacological treatment
SPINCODE is overall a two-year observational cohort study The rehabilitation study is a 6-months intervention study followed by a 18-months observational follow-up study The rehabilitation feasibility study will be a pre-post design without a control group the design is expected to be adapted and tested in a RCT study
The intervention consists of a physiotherapist-coordinated PT interdisciplinary outpatient rehabilitation offer for 6-months The intervention encompasses 3 individual sessions with the PT if needed individual consultations from the interdisciplinary team PT occupational therapist OT nurse and social worker a maximum of 6 hours and patient education in two group seminarsThe individual sessions are based on the following theories self-efficacy Focused and Acceptance Commitment Therapy FACT and shared decision makingperson-centered care Overall the PT offers advise on physical activity and supports the patients self-management The counselling is person-centered and derived from the shared goal setting at the initial assessment The PT has a coordinating role both internal by referring the patient to other health care professionals from the interdisciplinary team if needed and an external by supporting the patient in finding and take actions on relevant offers in the municipality Moreover if a patient has a private PT the patients PT is offered an online support from the coordinating PT The group sessions are two 2-hour group sessions with patient education delivered by the interdisciplinary team PT rheumatologist OT social worker and nurse Moreover it is an opportunity for peer support
Study setting
SPINCODE will be carried out at the Danish Hospital for Rheumatic Diseases located in the city of Sønderborg Denmark
Recruitment
Patients with low back pain suspected of axSpA will be referred according to the referral algorithm by general practitioners GPs ophthalmologists and dermatologists from the Counties of Southern Jutland departments of ophthalmology and gastroenterology at the Hospital of Southern Jutland University Hospital of Southern Denmark
Referring physicians will inform patients about the project prior to the referral to the DHR and note in the referral whether the patient has given permission to receive an introduction call from the research nurse If this permission is not noted in the referral first contact will be established at the first meeting in the outpatient clinic
Consultants responsible for visitation of referrals to the DHR will be prepared to screen referrals for patients with suspected axSpA according to the inclusion and exclusion criteria during the study period
If the patient has been introduced to the project and asked permission to receive information as described above the research nurse will call the patient inform about the study and perform a pre-screening to ensure that patients meeting to the screening visit most likely also can be included into the study Furthermore the research nurse will ask permission to send written information patients rights and the consent form electronically to the patients electronic mail box to ensure a consideration period of at least seven days
The trial participants are offered verbal information upon physical attendance If trial participants do not want oral information when physically present the right to a bystander is ensured by agreement on a telephone appointment when participation of a bystander during the telephone conversation can be realized
Randomisation and blinding
If the rehabilitation feasibility studys findings are promising the rehabilitation study will afterwards be tested in a randomised controlled study with a 11 allocation to either an outpatient physiotherapist-coordinated interdisciplinary rehabilitation in addition to pharmacological treatment or standard care
Due to the nature of the rehabilitation intervention it is not possible to blind the healthcare professionals and the patients The statistical analyses will be performed blinded to group allocation
Data collection
Outcomes in SPINCODE will be tested at baselinevisit 1 0-6 weeks visit 3 6 months visit 4 1 year visit 5 1½ year and visit 6 2 years
Ethics
The participants will be informed verbally and in writing about the study before providing their written consent to participate before the first consultation The study will be conducted in accordance with the Helsinki Declaration The leaflet Research subjects rights in health science research published by the Danish National Committee on Health Research Ethics is provided to all participants The Regional Committees on Health Research Ethics has approved the study Project ID S-20230055 Data will be stored and managed in the Open Patient Data Explorative Network OPEN which adheres to the European General Data Protection Regulations and the Danish data protection law
Aims
To set up an axSpA inception cohort among individuals with low back pain 3 months in the counties of Southern Jutland who are considered to be at risk for axSpA
To describe the epidemiology demographics clinical laboratory and imaging signatures in a population with low back pain suspected of axSpA and improve awareness about incipient axSpA
To test the feasibility of a novel outpatient interdisciplinary rehabilitation intervention for patients with low back pain suspected of SpA
To evaluate and compare the effect of a novel outpatient interdisciplinary rehabilitation intervention adjunct to pharmacological therapy for patients with suspected SpA by studying differences in pain fatigue mental and physical functioning work ability physical activity levels and quality of life among those with and without a definite axSpA diagnosis
Methods
The study consists of a medical part and a rehabilitation part The medical part is planned as a prospective observational single centre cohort study of consecutive patients with low back pain 3 months and 3 years symptom onset at age 18-45 years and suspected of axSpA referred from the Counties of Southern Jutland and followed at Danish Hospital for Rheumatic Diseases DHR for a consecutive period of two years In order to diagnose axSpA and to improve diagnostic accuracy there will be used novel imaging techniques like low-dose computed tomography ld-CT and dual energy computed tomography DECT in addition to standard of care magnetic resonance imaging MRI of the sacroiliac joints SIJ and spine
The rehabilitation design is developed in accordance with the Medical Research Councils framework for developing complex interventions The design will be tested in a feasibility study adapted as needed and planned to be tested in randomised controlled study RCT in addition to pharmacological treatment
SPINCODE is overall a two-year observational cohort study The rehabilitation study is a 6-months intervention study followed by a 18-months observational follow-up study The rehabilitation feasibility study will be a pre-post design without a control group the design is expected to be adapted and tested in a RCT study
The intervention consists of a physiotherapist-coordinated PT interdisciplinary outpatient rehabilitation offer for 6-months The intervention encompasses 3 individual sessions with the PT if needed individual consultations from the interdisciplinary team PT occupational therapist OT nurse and social worker a maximum of 6 hours and patient education in two group seminarsThe individual sessions are based on the following theories self-efficacy Focused and Acceptance Commitment Therapy FACT and shared decision makingperson-centered care Overall the PT offers advise on physical activity and supports the patients self-management The counselling is person-centered and derived from the shared goal setting at the initial assessment The PT has a coordinating role both internal by referring the patient to other health care professionals from the interdisciplinary team if needed and an external by supporting the patient in finding and take actions on relevant offers in the municipality Moreover if a patient has a private PT the patients PT is offered an online support from the coordinating PT The group sessions are two 2-hour group sessions with patient education delivered by the interdisciplinary team PT rheumatologist OT social worker and nurse Moreover it is an opportunity for peer support
Study setting
SPINCODE will be carried out at the Danish Hospital for Rheumatic Diseases located in the city of Sønderborg Denmark
Recruitment
Patients with low back pain suspected of axSpA will be referred according to the referral algorithm by general practitioners GPs ophthalmologists and dermatologists from the Counties of Southern Jutland departments of ophthalmology and gastroenterology at the Hospital of Southern Jutland University Hospital of Southern Denmark
Referring physicians will inform patients about the project prior to the referral to the DHR and note in the referral whether the patient has given permission to receive an introduction call from the research nurse If this permission is not noted in the referral first contact will be established at the first meeting in the outpatient clinic
Consultants responsible for visitation of referrals to the DHR will be prepared to screen referrals for patients with suspected axSpA according to the inclusion and exclusion criteria during the study period
If the patient has been introduced to the project and asked permission to receive information as described above the research nurse will call the patient inform about the study and perform a pre-screening to ensure that patients meeting to the screening visit most likely also can be included into the study Furthermore the research nurse will ask permission to send written information patients rights and the consent form electronically to the patients electronic mail box to ensure a consideration period of at least seven days
The trial participants are offered verbal information upon physical attendance If trial participants do not want oral information when physically present the right to a bystander is ensured by agreement on a telephone appointment when participation of a bystander during the telephone conversation can be realized
Randomisation and blinding
If the rehabilitation feasibility studys findings are promising the rehabilitation study will afterwards be tested in a randomised controlled study with a 11 allocation to either an outpatient physiotherapist-coordinated interdisciplinary rehabilitation in addition to pharmacological treatment or standard care
Due to the nature of the rehabilitation intervention it is not possible to blind the healthcare professionals and the patients The statistical analyses will be performed blinded to group allocation
Data collection
Outcomes in SPINCODE will be tested at baselinevisit 1 0-6 weeks visit 3 6 months visit 4 1 year visit 5 1½ year and visit 6 2 years
Ethics
The participants will be informed verbally and in writing about the study before providing their written consent to participate before the first consultation The study will be conducted in accordance with the Helsinki Declaration The leaflet Research subjects rights in health science research published by the Danish National Committee on Health Research Ethics is provided to all participants The Regional Committees on Health Research Ethics has approved the study Project ID S-20230055 Data will be stored and managed in the Open Patient Data Explorative Network OPEN which adheres to the European General Data Protection Regulations and the Danish data protection law
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None