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Collaborative Model of Care Between Orthopaedics and Allied Healthcare Professionals Trial (CONnACT)

6 de octubre de 2021 actualizado por: Bryan Tan, Tan Tock Seng Hospital

Osteoarthritis knee is the leading cause of chronic disability among older adults. Our current model of care is doctor-centric and inefficient leading to suboptimal use of allied health intervention for effective lifestyle and behaviour changes resulting in potentially, unnecessary surgery.

The study is designed using an effectiveness-implementation hybrid study design utilizing a mixed methods approach. The hybrid study has dual aims. The primary aim is to evaluate the clinical effectiveness (pain, function and quality of life) of a 12-week multidisciplinary (Orthopaedics, Physiotherapy, Dietetics, Psychology) personalized, community-based program for patients with knee osteoarthritis through a randomized-controlled trial. The secondary aim is to obtain data that will inform the context for implementation and guide future wider scale application. The investigators hypothesize that this multidisciplinary program is clinically more effective in the treatment of knee osteoarthritis at 12 months compared to standard care.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

BACKGROUND With a rapidly aging population, osteoarthritis is expected to become the 4th leading cause of global disability by 2020. Established guidelines for knee osteoarthritis strongly advocate lifestyle changes, such with exercises and weight loss as first line of treatment, whilst reserving surgery as the last resort. Our current model of care is doctor-centric and inefficient leading to suboptimal use of allied health intervention for effective lifestyle and behaviour changes resulting in potentially, unnecessary surgery. Redesigning the model of care by moving away from costly surgical treatment through the optimization and synergizing of proven non-surgical treatments is key to deliver value-based care.

AIMS AND HYPOTHESIS Primary Aim and Hypothesis. Evaluate the clinical effectiveness (pain, function and quality of life) at 12 months of a personalized, community based 3-month multidisciplinary program (Orthopaedics, Physiotherapist, Dietitian and Psychologist) as compared with usual care for patients with knee osteoarthritis. The investigators hypothesize that patients with knee osteoarthritis who undergo a personalized, community based 3-month multidisciplinary program will have better pain, function and quality of life scores at 12 months post initiation of program compared to patients who undergo usual care.

Secondary Aim. Evaluate the cost effectiveness of a personalized, community based 3-month multidisciplinary program (Orthopaedic, Physiotherapist, Dietitian and Psychologist) for patients with knee osteoarthritis. Qualitative assessment of the acceptability, feasibility and scalability of such a program

METHODOLOGY The study will be conducted as a single centre, single-blinded, gender stratified, block permutated randomized controlled trial using a mixed method approach (quantitative and qualitative), comparing a proposed new multidisciplinary personalized community-based model of care and the current model of care.

Patients with suspected knee osteoarthritis who are referred from the Polyclinics in the primary healthcare setting to the Tan Tock Seng Hospital Orthopaedic Specialist Outpatient Clinic. Patients will then be evaluated based on the inclusion and exclusion criteria and subsequently invited to join the study if eligible. Consent for participation into the study will be obtained prior to randomization. Randomization will be done via gender stratified permutated block randomization.

ECONOMIC EVALUATION An economic evaluation from a societal perspective will be undertaken to determine the cost effectiveness of the intervention. The incremental cost effectiveness ratio of this multidisciplinary non-surgical community-based program for knee osteoarthritis compared to routine care will be determined. Cost data will be collected via questionnaires and hospital databases to estimate both the direct medical, direct non-medical and indirect cost. Indirect cost of health-related productivity loss due to knee osteoarthritis will be calculated using a human capital approach. The primary measure of health benefit will be Quality of Life Years measure using the EQ-5D.

QUALITATIVE COMPONENT The qualitative component of our study will employ several qualitative methods such as focus group discussions and individual interviews with a variety of subjects including both patients and stakeholders. The focus will on identifying the potential barriers and facilitators to implementing and upscaling the intervention.

Tipo de estudio

Intervencionista

Inscripción (Actual)

114

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Singapur
      • Singapore, Singapur
        • Tan Tock Seng Hospital
      • Singapore, Singapur
        • St Luke Eldercare (AMK)

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

45 años a 99 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria

  1. National Institute for Health and Care Excellence (NICE) clinical criteria for knee osteoarthritis
  2. Radiographic severity of knee osteoarthritis - Kellgren Lawrence Score > 1
  3. Knee Injury and Osteoarthritis Outcome Score (KOOS4) ≤ 75
  4. Independent community ambulator with or without walking aid
  5. Age ≥ 45 years old
  6. Conversant in English/Chinese
  7. Subject will need to fulfill all the inclusion criteria for eligibility.

Exclusion Criteria

  1. Alternative diagnosis to knee osteoarthritis e.g. referred pain from the spine or hip
  2. Secondary arthritis e.g. inflammatory, post-traumatic
  3. Inability to comply with study protocol e.g. cognitive impairment
  4. Previous knee arthroplasty on the symptomatic knee
  5. Wheelchair bound patients
  6. Any other medical condition that study team determines may interfere with study involvement

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Control Arm

Current model of care

Patients will undergo the current standard of care in the Orthopaedic Outpatient Clinic in Tan Tock Seng Hospital. Patients will undergo routine consultation with an orthopaedic surgeon and will be provided with standard treatment as necessitated based on the assessment of the orthopaedic surgeon. Subsequent follow up appointments will be scheduled at the discretion of the orthopaedic surgeon. Patients will be referred to the physiotherapists, dietitian and psychologists as necessary for regular or adhoc sessions at the discretion of the allied health professional.
Otro: Current model of care
No controlled set of treatment assigned to patient. It is based totally on the discretion of the attending clinicians. It will generally contain an unspecific number of physiotherapy sessions. Other allied health involvement such as dietetics and psychological interventions will be on an ad hoc basis. In some cases, the orthopaedic surgeon may recommend for surgery.
Experimental: Intervention Arm

Multidisciplinary Community Program

Community based, personalized, structured, 12-week multidisciplinary program that includes Orthopaedics, Physiotherapy, Dietitics, Psychology interventions. This intervention involves the use of formal assessment such as BMI and psychological questionnaires to determine the need for dietetics or psychological intervention. In addition, there are educational sessions to improve patient's understanding of osteoarthritis and improve their activation level. An optional support group session will be arranged at approx. 3-4 months after completion of the 12-week intervention program to improve sustainability of treatment effect.
Otro: Multidisciplinary Community Program

Patient will undergoes 12 weeks of structured and personalized multidisciplinary community-based program, which consists of Physiotherapy, Dietetics and Psychology sessions. Patients will also attend 2 educational sessions. Physiotherapy and educational sessions are mandatory for all participants, while the need for dietetics and psychological interventions are determine using individual's BMI measurements and psychological questionnaires.

Inclusion criteria:

Dietetics: 23.5 < BMI <32.5; Psychology: PEG > 4 or PHQ-4 > 5 or PAM level < 3

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Knee Injury and Osteoarthritis Outcomes Score (KOOS4)
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
Change in disease specific pain and functional outcome scores between patients undergoing the multidisciplinary community program and the current model of care will be evaluated. A composite score of the following subscales will be calculated using the averaged score - Pain, Symptoms, Activities of Daily Living and Quality of Life will be calculated. Scores between 0 and 100 represent the percentage of total possible score achieved, with zero representing extreme knee problems and 100 representing no knee problems.
Assessed at baseline, 3 months, 6 months, 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Symptoms, Activities of Daily Living, Sports/Recreational Activities, Quality of Life
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
The five patient-relevant subscales of KOOS are scored separately: KOOS Pain (9 items); KOOS Symptoms (7 items); KOOS ADL (17 items); KOOS Sport/Rec (5 items); KOOS QOL (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
Assessed at baseline, 3 months, 6 months, 12 months
EuroQol-5 Dimensions (EQ-5D)
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
EuroQol-5 Dimensions (EQ-5D) which consist of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome.
Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - 30s chair stand test
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
To test leg strength and endurance. Total number of repetitions completed in 30 seconds is recorded.
Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - 40m fast-paced walk test
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
Measure of patient's walking speed. Time taken to complete 40 meters walk will be recorded in seconds.
Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - 4 stairs climb test
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
To assess the strength, balance and agility through ascending and descending a set number of steps. Time to ascend and descend steps (excluding turning around time) is recorded separately in seconds. Overall time taken (including the turn around time) to ascend and descend stairs is also recorded.
Assessed at baseline, 3 months, 6 months, 12 months
Functional Assessment - Timed up and go test
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
To assess patient's mobility and balance through the patient's ability to rise from a seated position to walk around a cone 3 meters away and return to the seated position. Time taken to perform the test in fast walking pace will be recorded in seconds.
Assessed at baseline, 3 months, 6 months, 12 months
Patient Health Questionnaire 4 (PHQ-4)
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months

Measurement for depression and anxiety rated on a 4 point Likert-type scale. 0 refers to 'Not at all'; 3 refers 'Nearly everyday'. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).

Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.
Assessed at baseline, 3 months, 6 months, 12 months
Patient Activation Measure (PAM)
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
Measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum. Each activation level reveals insight into an array of health-related characteristics, including attitudes, motivators, behaviors, and outcomes.
Assessed at baseline, 3 months, 6 months, 12 months
Pain, Enjoyment, General Activity Scale (PEG)
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
Measures the pain intensity and interference level using a three-item scale. Scale of 0 to 10 is used for each item. 0 refers 'no pain'; 10 refers 'worse pain'. Add the responses to the three questions, then divide by three to get a mean score (out of 10) on overall impact of points.
Assessed at baseline, 3 months, 6 months, 12 months
Body Mass Index (BMI)
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
Assessed if patient achieved weight loss during the study period. Weight and height of patient will be measured in m and kg respectively. Weight and height will be combined to report BMI in kg/m^2
Assessed at baseline, 3 months, 6 months, 12 months
Total Knee Replacement
Periodo de tiempo: Assessed at 3 months, 6 months, 12 months
Indicates if the patient undergoes a total knee replacement at any time during the study period.
Assessed at 3 months, 6 months, 12 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Cumulative Analgesia Consumption Score (CACS)
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
Objective measurement of patient's analgesics average weekly consumption based on the quantity multiplied by the category of analgesic medication according to the WHO pain relief ladder(1 point - non-opioid, 2 points - mild opioid, 3 points - strong opioid) in order to calculate a total score.
Assessed at baseline, 3 months, 6 months, 12 months
Semi-Quantitative Food Frequency Questionnaire (FFQ)
Periodo de tiempo: Assessed at baseline, 3 months, 6 months, 12 months
Understand the eating habits and dietary choice over time. 64 question questionnaire looking at the frequency of food consumption in different food group on a 5 point scale ranging from less than 3 times a month to more than once a day.
Assessed at baseline, 3 months, 6 months, 12 months
Sports Injury Rehabilitation Adherence Scale (SIRAS)
Periodo de tiempo: Assessed after each physiotherapist session
A measurement of the patient's compliance level to exercises done by the attending therapist. 3 question questionnaire with an answering scale of 1 to 5. Total score is derived from adding the 3 scores up.
Assessed after each physiotherapist session
Global perceived effect (GPE)
Periodo de tiempo: Assessed at 3 months, 6 months, 12 months
Patient will be asked to rate their overall recovery on a 7-point Likert scale. 1 refers to 'Very much improved'; 7 refers to 'Very much deteriorated'.
Assessed at 3 months, 6 months, 12 months
Patient Acceptable Symptom State (PASS)
Periodo de tiempo: Assessed at 3 months, 6 months, 12 months
A single-question used to assess patient's satisfaction in the treatment. Response will be either yes or no."When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life"
Assessed at 3 months, 6 months, 12 months
Patient-reported Treatment failure
Periodo de tiempo: Assessed at 3 months, 6 months, 12 months
Patient who answers 'no' to PASS will be ask to determine if they consider the treatment to have failed. Response will be 'yes' or 'no'. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?"
Assessed at 3 months, 6 months, 12 months
Costs
Periodo de tiempo: Assessed at 3 months, 6 months, 12 months
Cost questionnaire measuring the direct and indirect costs
Assessed at 3 months, 6 months, 12 months
Adverse Events
Periodo de tiempo: Assessed at 3 months, 6 months,12 months
Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded. AEs will be categorized into index knee or other sites and will be recorded and assessed for severity independent of whether or not there is a causal relationship with study treatments.
Assessed at 3 months, 6 months,12 months
University of California, Los Angeles(UCLA) activity score
Periodo de tiempo: Assessed at baseline, 3 months, 6 months and 12 months
1 question survey to understands patient physical activity level from a scale of 1(wholly inactive) to 10(regular participation in impact sports).
Assessed at baseline, 3 months, 6 months and 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Tan Tock Seng Hospital

Colaboradores

Singapore General Hospital
University of Sydney
University of Southern Denmark
Nanyang Technological University

Investigadores

  • Investigador principal: Bryan Tan, MBBS, MRCS, Tan Tock Seng Hospital
  • Silla de estudio: Soren Skou, PT, PhD, University of Southern Denmark
  • Silla de estudio: Josip Car, MD, PhD, Nanyang Technological University
  • Silla de estudio: Julian Thumboo, MBBS, FRCP, Singapore General Hospital
  • Silla de estudio: David Hunter, MBBS, PhD, University of Sydney

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de septiembre de 2018

Finalización primaria (Actual)

1 de febrero de 2021

Finalización del estudio (Anticipado)

31 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

15 de enero de 2019

Primero enviado que cumplió con los criterios de control de calidad

17 de enero de 2019

Publicado por primera vez (Actual)

18 de enero de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de octubre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

6 de octubre de 2021

Última verificación

1 de octubre de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NTF_JUL2017_I_C2_CQR_01
  • 2018/00408 (Otro identificador: NHG RDO - DSRB)

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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