Clinical trial NCT04352972: Hospital-based Usual cAre Versus Tele-monitoring Rehabilitation
Official title: Innovative Tele-monitored Home-Based Program for Post Total Knee Replacement Rehabilitation: A Noninferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: University of the Sunshine Coast
name: Duke University
name: Duke-NUS Graduate Medical School
name: Monash University
First posted: 2020-04-20
Enrollment: 114
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis (OA) is a common, chronic, and costly condition, and patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Although outpatient rehabilitation attendance is associated with better functional outcomes, access to rehabilitation care is limited as outpatient rehabilitation is costly and inconvenient for patients and their caregivers, resulting in suboptimal adherence. A tele-monitored home-based exercise program provides the best access to rehabilitation care and is a potential alternative for the majority of patients who do not require intensive "hands-on" rehabilitation therapy.

The primary aim of this non-inferiority randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of an innovative tele-monitored rehabilitation program versus that of currently standard, hospital-based outpatient rehabilitation program among patients post TKR.

Detailed description: Study Hypotheses

Primary hypothesis: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to an 10-week hospital-based rehabilitation at 3 and at 6 months after total knee replacement (TKR) in improving physical function (fast gait speed).

Secondary hypothesis 1: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to a 10-week hospital-based rehabilitation at 3 and at 6 months after TKR in improving knee pain, physical impairments, and health-related quality of life.

Secondary hypothesis 2: A 10-week tele-monitored home-based exercise program will be more cost-effective than the 10-week hospital-based rehabilitation in total TKR-related costs

Approach and Methods

This will be an assessor-blinded, parallel design, non-inferiority randomised controlled trial, with assessments preoperatively(baseline), 3 months, and 6 months after total knee replacement surgery. The protocol conforms to the CONSORT guidelines for non-inferiority randomized controlled trials. Post TKR, all participants will undergo daily inpatient rehabilitation. At discharge, they will be given a standard booklet with advice on ice therapy and home exercises to be performed. Two weeks post TKR, randomization will occur and participants will be randomised to receive either the telemonitored home exercise program or the hospital-based rehabilitation program.

Eligibility criteria: Inclusion Criteria:

* Primary unilateral total knee replacement
* Age \>= 45 years
* Willingness to be randomized to either tele-monitored home exercise program or outpatient rehabilitation program
* Ability to provide informed consent

Exclusion Criteria:

* Further lower limb joint replacement surgery anticipated within the next 6 months
* Rheumatoid arthritis and other systemic arthritis
* A previous history of stroke and other major neurological conditions
* An intention to transfer to step-down care facilities post-operatively.

Primary outcomes:
measure: Difference in Fast-paced gait speed
timeFrame: Pre-operation; 3 months and 6 months post-surgery
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Pre-operation; 3 months and 6 months post-surgery
measure: Quadriceps muscle strength
timeFrame: Pre-operation; 3 months and 6 months post-surgery
measure: 30s chair stand test
timeFrame: Pre-operation; 3 months and 6 months post-surgery
measure: Knee Pain: Numeric Pain Rating Scale (NPRS)
timeFrame: Pre-operation; 3 months and 6 months post-surgery
measure: Knee range-of-motion
timeFrame: Pre-operation; 3 months and 6 months post-surgery
measure: EuroQol-5 Dimensions (EQ-5D-5L) descriptive system
timeFrame: Pre-operation; 3 months and 6 months post-surgery
measure: Cost
timeFrame: 3 months and 6 months post-surgery
measure: Treatment satisfaction: scale
timeFrame: 3 months post-surgery
measure: Treatment credibility
timeFrame: 3 months post-surgery
measure: STarT Back Screening Tool
timeFrame: Pre-operation; 3 months and 6 months post-surgery
measure: Örebro Musculoskeletal Pain Screening Questionnaire (short form)
timeFrame: Pre-operation; 3 months and 6 months post-surgery
Other outcomes:
measure: Number of adverse events
timeFrame: 3 months and 6 months post-surgery
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References: