Formative Evaluation of a Mobile Application Facilitated Self-directed Rehabilitation Programme for Knee Osteoarthritis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorSingapore General Hospital

About this trial

In Singapore, knee osteoarthritis (OA) is a prevalent musculoskeletal condition, reflecting global trends of an aging population and lifestyle factors. With Singapore's rapidly aging population and the rising prevalence of obesity and sedentary lifestyles, knee OA has become increasingly common. According to recent studies, symptomatic OA of the knee affects around one-fifth (\~300K) of Singaporeans aged 50 years or older. Individuals with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. While knee replacement surgery is an effective option for severe knee OA, it is costly and there are risks of complications, and should only be considered when all appropriate non-surgical treatment options have been exhausted. Existing research suggests at least a quarter of knee replacements could have been avoided through more optimal conservative treatments.

Despite established healthcare systems and treatment pathways, studies in several settings report that the majority of patients with OA do not receive appropriate and optimal medical care. In Singapore, several factors such as cost, extended wait times, cultural factors and travel inconvenience pose barriers to accessing physiotherapy services. These factors hinder patients' ability to access care resulting in suboptimal care, poor outcomes, and needless economic burden. Thus, there is a large unmet need for innovative and flexible strategies to deliver effective conservative management and treatment for knee OA widely and at a relatively low cost.

Solutions that empower individuals and allow for self-directed rehabilitation without the need for real-time human supervision could be the key to improve effectiveness, accessibility and reduce the reliance on healthcare manpower. Given the prevalence of mobile phone, mobile applications offer a promising avenue for delivering self-directed rehabilitation programs to adults with knee OA. Previous self-directed rehabilitation programs for patients with knee OA have shown promise, however, the adoption and adherence to these programmes remain low, particularly among older adults who may not be technologically savvy. Developing an application that is tailored to the needs and capabilities of older adults with knee osteoarthritis is crucial to improve engagement and long-term adherence to the programme.

The investigators have previously developed a technology-enabled self-directed rehabilitation program for patients who have undergone TKR for primary knee OA. Subsequently, Managing Osteoarthritis of the knee using Therapist-Technology Optimized Rehabilitation (MO-knee-TOR) - a standalone mobile app to facilitate self-directed rehabilitation and complement a "blended" care approach involving an initial face-to-face session with the physiotherapist was developed. MO-knee-TOR was developed for patients with TKR and subsequently evaluated in 2 pilot randomised controlled trials (RCTs). In one of the RCTs, it was found that self-directed rehabilitation post TKR facilitated using the mobile application improved exercise adherence without compromising safety and clinical outcomes. In this current proposal, MO-knee-TOR is adapted for conservative knee OA management through a single-arm pre-post feasibility study with a nested qualitative component.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meet the National Institute for Health and Care Excellence (NICE) osteoarthritis clinical criteria (7)

aged 45 years and over

activity related knee joint pain

morning stiffness ≤30 min

Disqualifiers

Patients who meet any of the exclusion criteria mentioned below will be excluded from participation.

Rheumatoid arthritis and other systemic arthritis

A previous history of stroke and other major neurological conditions

An intention to undergo knee joint replacement surgery or have had a knee joint replacement

Trial design

Design model

Single group

Treatments tested in this trial

  • Self-directed rehabiliation using the mobile application

    Device

    Participants will be instructed on the installation and use of the mobile application on their personal mobile phones during their first outpatient physiotherapy session. Participants will then have to perform the assigned tasks using the mobile application for 12 weeks

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Self-directed rehabilitation using the mobile applicationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility

The feasibility of evaluating the prototype in a larger trial will be assessed using predefined progression criteria including, including recruitment and retention rates, adherence to the program, incidence of adverse events, and improvement in function. Progression will be guided using thresholds categorized as "proceed," "proceed with protocol amendments," or "significant amendments required" based on the criteria defined for each feasibility domain.

Time frame
12 weeks after using the mobile application

Secondary outcomes

1

Gait speed

Gait speed will be measured from walking a distance of 4m at comfortable pace and 9m at fast pace with a 2m acceleration and deceleration zone before and after the timed section of 9m.

Time frame
Pre-intervention; 12 weeks after using the mobile application
2

Knee range-of-motion

A long-arm goniometer will be used to measure active-assisted knee flexion and extension range-of-motion with the participants in supine position

Time frame
Pre-intervention; 12 weeks after using the mobile application
3

Incidental and planned exercise (IPEQ)

This is a tool developed to measure physical activity, distinguishing between incidental exercise (activities that are not planned but contribute to overall physical activity, like walking to work or taking the stairs) and planned exercise (deliberate, structured exercise like going to the gym or running)

Time frame
12 weeks after using the mobile application
4

Health-related quality of life

The EQ5D-5L is a standardised instrument to measure health related quality of life in cost-effectiveness analysis

Time frame
Pre-intervention; 12 weeks after using the mobile application

Other outcomes

1

Education

Participants will report their highest level of education attained, categorized into predefined levels (e.g., primary, secondary, tertiary).

Time frame
Pre-intervention
2

Race

Race will be self-reported by participants and categorized into predefined groups (e.g., Chinese, Malay, Indian, Others) based on standard demographic classifications.

Time frame
Pre-intervention
3

Co-morbidities

Co-morbidities will be recorded based on participant self-report and/or medical records, including the presence of chronic conditions such as hypertension, diabetes, cardiovascular disease, and others.

Time frame
Pre-intervention
4

Kellgren-Lawrence Grading

Severity of knee osteoarthritis will be assessed using the Kellgren-Lawrence (K-L) grading scale based on radiographic findings, with grades ranging from 0 (no radiographic features of osteoarthritis) to 4 (severe osteoarthritis).

Time frame
Pre-intervention

Sponsors and contacts

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