NCT03809975

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

January 15, 2019

Last Update Submit

October 6, 2021

Conditions

Osteoarthritis

Keywords

KneeOsteoarthritisModel of careMulti-disciplinary

Outcome Measures

Primary Outcomes (1)

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS4)

    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

Secondary Outcomes (11)

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Symptoms, Activities of Daily Living, Sports/Recreational Activities, Quality of Life

    Assessed at baseline, 3 months, 6 months, 12 months

  • EuroQol-5 Dimensions (EQ-5D)

    Assessed at baseline, 3 months, 6 months, 12 months

  • Functional Assessment - 30s chair stand test

    Assessed at baseline, 3 months, 6 months, 12 months

  • Functional Assessment - 40m fast-paced walk test

    Assessed at baseline, 3 months, 6 months, 12 months

  • Functional Assessment - 4 stairs climb test

    Assessed at baseline, 3 months, 6 months, 12 months

  • +6 more secondary outcomes

Other Outcomes (9)

  • Cumulative Analgesia Consumption Score (CACS)

    Assessed at baseline, 3 months, 6 months, 12 months

  • Semi-Quantitative Food Frequency Questionnaire (FFQ)

    Assessed at baseline, 3 months, 6 months, 12 months

  • Sports Injury Rehabilitation Adherence Scale (SIRAS)

    Assessed after each physiotherapist session

  • +6 more other outcomes

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

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.

Other: Current model of care

Intervention Arm

EXPERIMENTAL

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.

Other: Multidisciplinary Community Program

Interventions

Multidisciplinary Community ProgramOTHER

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

Intervention Arm
Current model of careOTHER

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.

Control Arm

Eligibility Criteria

Age45 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • National Institute for Health and Care Excellence (NICE) clinical criteria for knee osteoarthritis
  • Radiographic severity of knee osteoarthritis - Kellgren Lawrence Score \> 1
  • Knee Injury and Osteoarthritis Outcome Score (KOOS4) ≤ 75
  • Independent community ambulator with or without walking aid
  • Age ≥ 45 years old
  • Conversant in English/Chinese

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Luke Eldercare (AMK)

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Related Publications (3)

  • Tan BY, Yang SY, Pereira MJ, Tan CY, Lim CJ, Ng JP, Lee KT, Pua YH, Briggs AM, Hunter DJ, Skou ST, Thumboo J, Car J. Collaborative model of care between orthopaedics and allied healthcare professionals (CONNACT) in knee osteoarthritis: Effectiveness-implementation hybrid randomized controlled trial of a community-based, multidisciplinary, stratified intervention. Osteoarthritis Cartilage. 2024 Aug;32(8):972-981. doi: 10.1016/j.joca.2024.04.018. Epub 2024 May 6.

    PMID: 38710437DERIVED

  • Tan BY, Pereira MJ, Yang SY, Hunter DJ, Skou ST, Thumboo J, Car J. Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial. BMC Musculoskelet Disord. 2020 Oct 16;21(1):684. doi: 10.1186/s12891-020-03695-3.

    PMID: 33066746DERIVED

  • Tan BY, Ding BTK, Pereira MJ, Skou ST, Thumboo J, Car J. Collaborative model of care between Orthopaedics and allied healthcare professionals trial (CONNACT) - a feasibility study in patients with knee osteoarthritis using a mixed method approach. BMC Musculoskelet Disord. 2020 Sep 4;21(1):592. doi: 10.1186/s12891-020-03611-9.

    PMID: 32887594DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Bryan Tan, MBBS, MRCS

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

  • Soren Skou, PT, PhD

    University of Southern Denmark

    STUDY CHAIR

  • Josip Car, MD, PhD

    Nanyang Technological University

    STUDY CHAIR

  • Julian Thumboo, MBBS, FRCP

    Singapore General Hospital

    STUDY CHAIR

  • David Hunter, MBBS, PhD

    University of Sydney

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Resident

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 18, 2019

Study Start

September 18, 2018

Primary Completion

February 1, 2021

Study Completion

December 31, 2021

Last Updated

October 8, 2021

Record last verified: 2021-10

Locations

SG(2)