NCT Number: NCT06904885
This project aims to bridge the gap between guideline recommendations and clinical practice in osteoarthritis (OA) management. By implementing a systematic, evidence-based model of care, the project seeks to improve patient outcomes, reduce healthcare costs, and provide equitable access to care. The project consists of three phases. In the first phase the current OA care is mapped through registry review and questionnaires and interviews of patients and healthcare professionals. In the second, implementation phase of the project, a plan will be created how to support healthcare professionals in delivering care according to the new model of care and training and support will be offered according to the plan. In the third phase of the project, the implementation success will be evaluated, and the costs of OA care evaluated and compared to baseline data. In addition, patient-reported data will be collected from those patients, who participate in the group-based exercise and education program.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Osteoarthritis (OA) is a growing global health challenge, due to the significant increase in prevalence of knee and hip OA. In Finland, OA care costs are substantial, driven by diagnostic procedures, medical treatments, and indirect costs such as work absenteeism. The international guidelines recommend education, exercise, and weight management as first-line treatment options, but adherence to guidelines is inconsistent. This project aims to explore regional differences in OA care and beliefs and OA care practices in Finland. In addition, we will implement and evaluate a guideline-based model of care for hip and knee OA, that includes the Good Life with osteoarthritis from Denmark (GLA:D®) program as the preferred non-surgical management option in local care pathways. In addition, the aim is to share evidence-based OA knowledge and management skills nationwide.
This study is a hybrid type-3 benchmarking-controlled implementation trial. It is nested in primary healthcare in two Wellbeing Services Counties. The study includes three phases: pre-implementation, implementation, and evaluation. The pre-implementation activities include mapping the current OA care through registry review (healthcare utilization and costs from 2019-2024). In addition questionnaires and interviews of patients and healthcare professionals (beliefs and practices) will be conducted. Planned activities of the implementation phase include developing and integrating a new model of care (including GLA:D®) into local care pathways, and training physiotherapists to deliver it. Implementation theories and multifaceted implementation strategies will be used and adapted locally. The activities to evaluate the process include assessment of the implementation outcomes on healthcare professional and organizational levels, healthcare resource utilization and cost outcomes (1, 3 and 5 years) using registry data. In addition outcomes reported by patients participating in the GLA:D program will be collected at 3 months and 1, 3 and 10 years.
This project aims to bridge the gap between guideline-recommended OA-management and clinical practice. By implementing a systematic, evidence-based model of care, the study seeks to improve patient outcomes, reduce healthcare costs, and provide equitable access to care. The findings will inform future OA care strategies and will be disseminated and adapted to other healthcare contexts in Finland and can be adapted also internationally. The findings will be published in peer-reviewed journals and presented in national and international conferences.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Data from national registries:
Collection of GLA:D patient-reported outcomes:
Inclusion criteria
Exclusion criteria
Guideline-based model of care including GLA:D (Good Life with osteoArthritis from Denmark) -program that includes training for physiotherapists and group based education and exercise for patients with hip and knee OA.
Time frame: 1 (primary endpoint), 3 and 5 years after implementation compared to baseline 2018-2024
Healthcare cost associated with the new care pathway incluing annual healthcare consultation prevalence, number and cost of hospitalizations, OA-related surgical interventions and primary and specialized healthcare and outpatient specialist visits. Filled prescriptions, number and duration of OA-related sick leaves and disability pensions. Costs will be analysed using data from national registers in pre and post implementation, both within the pilot Wellbeing Services Counties and between the pilot and other Wellbeing Services Counties.
Time frame: 1 (primary endpoint) 3 and 5 years after implementation
Proportion of patients with hip and knee related symptoms and OA who contact healthcare that are referred to direct access physiotherapy and to GLA:D program
Time frame: 1, 3 and 5 years after implementation
Number of trained GLA:D trainers and physiotherapists in Finland, recorded in GLA:D Finland database by PI.
Time frame: 1, 3 and 5 years after implementation
Number of participants in GLA:D groups
Time frame: Baseline, 3 months, 1, 3 and 10 years
Numerical rating scale (NRS) 0-10, where 0 means no pain (better outcome) and 10 worst possible pain (worse outcome). a) worst pain b) average pain
Time frame: Baseline, 3 months, 1, 3 and 10 years
yes / no
Time frame: Baseline, 3 months, 1, 3 and 10 years
UCLA activity score, 1= wholly inactive (worse outcome), 10 = regularly participate in impact sports (better outcome)
Time frame: Baseline, 3 months, 1, 3 and 10 years
Are you afraid that your joints will be damaged from physical activity and exercise? yes / no
Time frame: Baseline, 3 months, 1, 3 and 10 years
Yes / no, and type of pain killers
Time frame: Baseline, 3 months, 1, 3 and 10 years
Employed / student / unemployed / on sick leave full time / on sick leave part time / early retirement due to low ability to work / self-imposed early retirement / retired
Time frame: Baseline, 3 months, 1, 3 and 10 years
no / yes, under 1 month, yes 1-3 months, yes more than 3 months
Time frame: Baseline, 3 months, 1, 3 and 10 years
Mobility (1-5), self-care (1-5), usual activities (1-5), pain/ discomfort (1-5), anxiety / depression (1-5), eq-vas (0-100). Lower scores indicate a worse outcome.
Time frame: Baseline, 3 months, 1, 3 and 10 years
KOOS-12 asked if most affected joint is knee and HOOS-12 asked is most affected joint is hip. Scale 1-4 for each item, a lower score indicates a better outcome.
Time frame: 3 months, 1, 3 and 10 years
Much worse, an important worsening - much better an important improvement. 7-point likert scale, where a higher score indicates a better outcome.
Time frame: 3 and 12 months
1-5 Not at all satisfied - very satisfied, higher score indicates a better outcome.
Time frame: 3 months, 1, 3 and 10 years
Never (1), every month (2), every week (3), every day (4), several times a day (5), a higher score indicates a better outcome.
Time frame: 3 months
Numeral value
Time frame: Baseline, 3 months, 1, 3 and 10 years
Number of falls
Time frame: 3 months
Number of participated GLA:D sessions / participant.
Time frame: 1, 3 and 5 years after implementation
Number of sites training / implementing GLA:D -program in Finland. In numbers, based on documentation on GLA:D database by PI.
Time frame: 1, 3 and 5 years after implementation
Number of active GLA:D groups running, numbers, based on documentation on GLA:D Finland database by PI.
Time frame: 1, 3 and 5 years after implementation
Descriptive qualitative reporting based on research diary: When and how modifactions in the Model of Care and Care pathways occured, whether it was unplanned or planned, reasons and goals for modification.
Time frame: after delivering first GLA:D program and at 12 months
The multiprofessional version of Determinants of Implementation Behaviour Questionnaire (DIBQ-mp)
Clinician reported determinants of implementation of guideline-based model of care and GLA:D program, designed according to the Theoretical Domains Framework. The items will be scored each separately on 7-point likert scale, where a lower score indicates that item being a barrier (worse outcome) and higher score towards facilitator (better outcome).
Time frame: Baseline
Male / female / other
Time frame: Baseline
in years
Time frame: Baseline
Living alone or with others
Time frame: Baseline
Basic and vocational education
Time frame: Baseline
High blood pressure and high cholesterol, Musculoskeletal conditions, Cardiovascular and blood diseases, Neurological diseases, Hormonal diseases, urinary diseasses, Gastrointestinal and liver diseases, Lung diseases, Cancer, Mental conditions, Diseases in the skin and other chronic diseases
Time frame: Baseline
Smoking status
Time frame: Baseline
Duration of joint symptoms in months / years
Time frame: Baseline, 1, 3 and 10 years
Most affected joint (right/left hip, right/left knee)
Time frame: Baseline, 3 months, 1, 3 and 10 years
Other affected joints (right/left hip, right/left knee)
Time frame: Baseline
Previous injury that cuaused the person consult a doctor
Time frame: Baseline
No / yes, more than 6 months ago / yes, within last 6 months / don't know
Time frame: Baseline
Knee: load related pain, reduced functional capacity, morning stiffness, crepitus, reduced knee movement, bony enlargement, age, sex, overweight, previous joint injury, occupational / recreational overuse / family members with osteoarthritis
Hip: hip pain, stiffness after inactivity, reduced functional capacity, reduced hip flexion, reduced internal hip rotation, painful internal hip rotation, age, sex, overweight, previous joint injury, occupational / recreational overuse / family members with osteoarthritis
Time frame: Baseline (previous and planned surgery), 3 months, 1, 3 and 10 years (planned surgery)
Type and time of surgery
Time frame: Baseline, 3 months, 1, 3 and 10 years
0-100 points, higher score indicates a higher risk (<40 points = low risk, 40-50 points = medium risk, >50 points = high risk)
Time frame: Baseline
1-5 1= very large / complete improvement, 5 = Very small or no improvement
Contact information is provided by the study sponsor or research team.
University of Jyvaskyla
Other
Acronym: FIN-OA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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