Digitally Delivered Education and Exercises for Patients With Hand Osteoarthritis-An Observational Study
Conditions: Hand Osteoarthritis, Wrist Osteoarthritis, Thumb Osteoarthritis, Finger Osteoarthritis
Sponsor: Joint Academy

Effects of 12-week Digital Treatment in Patients With Hand OA on Pain and
Function
NCT05499559
May 25, 2021
Malmö, Sweden

Survey of the field
Musculoskeletal conditions are identified by the Global Burden of Disease Study as a leading
cause of global morbidity (1). Estimates of the need for rehabilitation services show that at least
one in every three people in the world needs rehabilitation at some point in their life course (2).
As disability becomes an increasingly large component of disease burden and health expenditure,
greater research and development investment is needed to identify new, more effective
intervention strategies (1).
Osteoarthritis (OA) is one of the leading causes of disability worldwide and due to its rising
prevalence, the identification of appropriate care and care delivery modalities is a priority for the
health care systems (3, 4). Exercise and education constitute the first-line intervention for people
with knee, hip and hand OA and have been shown to be effective regardless of symptoms and
disease severity (5, 6, 7) International guidelines recommend that first-line interventions for the
majority of musculoskeletal conditions should involve nonsurgical management with exercise
and education guided by a physiotherapist (PT) and based on a personalised care approach (8, 9).
OA of the hand is probably the most common form of OA and almost 50% of women and 25%
of men will be affected during the life course (10). Self-management strategies includes a wide
range of strategies such as education for strengthening or stretching exercises, joint protection
education for activity and pacing, use of proper body mechanics, and assistive devices to
improve pain, reduce inflammation, lower additional risk of deformities, and enhance
performance (7). Systematic reviews that compared joint protection strategies to usual care have
shown similar effects at short-term and superior effects at mid- and long-term compared to usual
care (11).
To implement the guidelines, the Better Management of Patients with OsteoArthritis (BOA), a
face-to-face concept including education and an option to exercise, has been developed and is
offered at primary care clinics in Sweden since 2008 for patients with hip- knee- and hand OA
(12). BOA has previously been found to reduce pain and improve function and quality of life in
patients with hip and knee OA (9). Unfortunately, there is a discrepancy between recommended
treatment and what patients receive and around 30% of people with OA seeking care go through
first line management (13).

Traditional face-to-face interventions present barriers, such as limited access and lack of
flexibility, which may limit the patients’ adherence with the interventions (14). Digital delivery
of the management program may be one way of overcoming such barriers (15, 16). Telehealth,
defined as the ‘delivery of healthcare at a distance using information and communication
technology’ could be a solution to many access barriers and has been rapidly adopted by many
healthcare professions and accelerating even more throughout the COVID-19 pandemic (17,18).
Literature investigating the use of telehealth for the management of musculoskeletal pain is
growing. Systematic reviews have demonstrated that telehealth can provide improvements in
pain, physical function and disability that are similar to that of usual face-to-face care for
individuals with musculoskeletal conditions such as osteoarthritis for the knee and hip (19, 20).
The use of telehealth also seems to increase exercise adherence for a variety of musculoskeletal
conditions (21, 22). To our knowledge, digital self-management programs for OA of the hand
have not yet been evaluated.
Joint Academy® (JA), a digitally delivered treatment program with exercise and patient
education was developed to increase access to and facilitate implementation of guideline derived
and evidence-based treatment for OA. The first JA program was introduced in 2016 for persons
with hip- and knee OA and participants reported reduced pain and improved function during up
to 48 weeks of treatment (23). A recent randomised controlled trial on patients with knee OA
showed that the digital program was superior to usual care (24). Since late 2021, a digital
program for OA of the hand is also available on the platform.
Project description
This is an observational registry-based study.
Purpose and goal
The overall aim of this project is to evaluate changes in health outcomes during participation in
the digitally delivered treatment programme Joint Academy® (JA) containing exercise and
education for patients with osteoarthritis (OA) of the hand.
Specific research questions are:

(1) What are the short-term changes in health outcomes of digitally delivered treatment for
OA of the hand? Primary outcome is to examine pain and perceived hand function in
participants following 3 months of digitally delivered first‐line treatment for hand OA
Main exposures and outcomes
All participants answer patient- and disease relevant socio-demographic and outcome
questionnaires at baseline and every third month during treatment. Additionally, participants
report pain every week.
Pain will be assessed using the Numerical Rating Scale (NRS, discrete boxes 0–10) with the
instruction: “Mark on this scale how much pain you had the last week in your hand”, followed by
a 0–10 scale where 0 was defined as No pain and 10 was defined as Maximum pain (25).
To evaluate hand function, the Functional Index for Hand OsteoArthritis (FIHOA) will be
distributed. The FIHOA is a 10-item questionnaire based on a semi-quantitative assessment
scoring the disease on a 4-point scale. The FIHOA has been shown to be valid, sensitive,
clinically relevant for the population and shown consistency and acceptable reliability (26). The
literature also suggests it is associated with pain, muscle strength and health related quality of
life in people with hand OA (27).
Among other outcomes to be reported are health-related quality of life assessed with the EuroQol
– 5 dimension descriptive system (EQ-5D-5L), work situation, medication use (dichotomous
reply, yes/no), changes in medications, willingness for surgery (dichotomous reply, yes/no),
physical activity, exercise, fear of physical activity (yes/no) and motivation to start exercising
using a Numerical Rating Scale (NRS, discrete boxes 0–10).
All outcomes will be self-assessed and self-entered using the digital program interface.
Demographic and socioeconomic data and data on the participants’ overall health and
characteristics (e. g age, gender, educational level BMI) will be collected at inclusion. The
exposure and outcome measures are described in Table 1.
The digital program Joint Academy®

In an attempt to scale and improve implementation of evidence-based guideline-derived first-line
treatment for a number of musculoskeletal conditions (education and exercise), the digital
self-management and education program Joint Academy® (JA) was developed in Sweden. The
first JA program was developed in 2014 for persons with hip- and knee OA (28). The program
for hand OA is available for patients since late 2021. The program is part of the health-care
system in Sweden.
Participants join the programme through recommendation by their local physiotherapist (PT),
occupational therapist (OT) or orthopaedic surgeon, via online advertisements and campaigns
placed on search engines and social networks, or through their insurance company. A majority of
included participants had a clinical diagnosis of hand arthritis from a PT, OT or physician, and
all had a physical visit with a healthcare provider regarding their hand OA prior to joining JA.
The clinical diagnosis of OA was confirmed by a PT or OT via telephone, or if deemed
necessary the patient was recommended to seek face-to-face care before inclusion in the
programme.
The Joint Academy® (www.jointacademy.com) program for people with hand OA consists of
video instructed and progressively adaptable daily exercises, patient education through text
lessons, possibility for a social chat group with other patients and a continuous asynchronous
chat function with a personal reg. physiotherapist who supervises the patient during the full
participation
period.
The
program
also
contains three telephone consultations with a
physiotherapist that were compulsory, one at the start, one after six weeks and one after three
months. The intervention procedure is similar to that for hip and knee OA, which is thoroughly
described in previous studies (23, 28).
Statistical analysis
We will develop a specific statistical analysis plan for each specific sub-study that will be
conducted to answer the aforementioned research questions.
To describe the sample, we will use means and standard deviations (SDs), frequencies and
percentages. These will follow several general principles. We will aim for the inclusion of all
available patients to limit potential selection bias. In the statistical modelling we will aim for

estimation of causal effects and statistical models will be chosen accordingly using direct acyclic
graphs (DAGs) to enable proper confounding control. For confounding control, we will use
regression models or inverse probability weighting. For analysis of panel data (i.e. longitudinal
repeated measurements of the participants and/or data clustered by caregiver) we will use
conditional or marginal models. For time-to-event data we will use the Cox regression model, or,
if appropriate, a parametric version. For mediation analysis, we will use linear models or
maximum likelihood structural equation models when appropriate. For categorical outcomes we
will use other approaches such as logit and probit models. We will report the results from all
analyses as relevant estimated effect size (such as risk differences, risk ratios or hazard ratios)
with 95% confidence intervals and interpret these for clinical relevance, irrespectively of
statistical significance.
Power calculation
Power analysis revealed that for the initial short-term follow-up, a sample size of 70 participants
will be enough to identify a minimally clinical important change of 1.5 units in pain with a
calculated mean pain of 5.2 (sd 2.2) at start, power of 80%, p<0.05.
For the other studies, we will not perform any power calculation. This is because the question of
power can be considered secondary in such a setting where the sample size is driven by data
availability and not decided a priori. Therefore, we will include all the available data from the
start.
Ethical considerations
Storage and management of data
The data set will be stored in a database at Arthro Therapeutics head office in Malmö. The
platform is designed to securely store, manage and analyse data in accordance with the European
Union general data protection regulation (GDPR). The process of linkage, storage and
management of data, the role of informed consent in register-based research and safeguarding the
integrity of study participants follows the legal and ethical frameworks as described by Swedish
law and ethical boards. This has been described by Ludvigsson et al (30).

Data sharing
All information regarding individual patients is subject to confidentiality in accordance with The
Public Access to Information and Secrecy Act (SFS 2009:400) chapter 25 article 1. Therefore, no
unauthorised person will have access to data.
Significance
Preliminary results
∙Initial observational reports on the first digital JA programme for persons with hip or knee OA
suggest that participation in JA for six weeks was associated with a clinically relevant decrease
in pain and an increase in physical function, as well as a decreased fear of physical activity (23).
These effects were maintained up to 48 weeks during participation in the treatment program (29).
∙Costing analysis of the JA program for persons with hip or knee OA have shown that the digital
model overall costs around 25% of the existing face-to-face model of care (31).
∙A Randomised Controlled Trial on patients with knee OA has shown that the digital JA
programme was superior to routine treatment in a United Kingdom context (24).
Clinical significance
In the management of OA, overall adherence to clinical guidelines is low and implementation of
strategies and removal of existing barriers against the application of evidence-based guidelines
could facilitate the transfer of scientific evidence into clinical practice and contribute to
optimising the quality of healthcare. Telehealth such as the digital JA program is scalable and has
the potential to improve reach and access to evidence-based first-line treatment for a large
number of individuals with musculoskeletal conditions who have internet access. Previous
results for patients with knee and hip OA also suggest that the digital platform could offer a
cost-effective alternative to the existing models of care. Depending on the extent to which the

digital model substitutes for the existing model of care, significant health-care resources can be
saved.
Access to personnel
More than 250 physiotherapists are involved in JA and treating patients on a regular basis.
Arthro Therapeutics has over 100 employees working with the design, adherence strategies and
implementation of the platform, including operational team, research team etcetera.
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Tables
Table 1. Description of the single variables collected from the Joint Academy (JA) database.
Sign up /
Week 0
We
ek
1
Every
week
Every
other
week
3
mon
ths
6
mon
ths
9
mon
ths
12
mont
hs
Outcomes
Diagnostic questions (symptoms, red
flags etc)
X
Weight and height / BMI
X
Age
X
Gender
X
Most painful joint (choose one)
X
pain locations (one or many)
X
X
X
X
X
if arthroscopy has been performed
X
if patient feels the need for surgery
of joint
X
X
X
X
X
if surgery is scheduled
X
X
X
X
X
if surgery has been cancelled due to
JA
X
X
X
X
If pain medication the last three
months, and if so what type
X
X
X
X
X
If pain medication has been changed
since starting JA
X
X
X
X
If so, which are changed and in what
way
X
X
X
X
FIHOA hand function score
X
X
X
X
X
If has lung disease (COPD, asthma
etc)
X
If has diabetes
X

If has cardiovascular disease
X
If has arthritis (e.g RA)
X
If has balance problems (e.g. due to
neurological disease such as PD)
X
Free text medical information
X
X
X
X
X
Level of exercise (defined in
category of minutes)
X
X
X
X
X
Level of activity in daily living
(defined in cat of min)
X
X
X
X
X
If afraid to get hurt during physical
activity / exercise (kinesiophobia)
X
X
X
X
X
30 second chair stand test
X
X
X
X
X
X
Specific joint pain (0-10 NRS)
X
X
X
X
X
X
X
Overall health (0-10 NRS)
X
X
X
X
X
X
X
EQ5D-5L
X
X
X
X
X
Educational level
X
Work situation
X
X
X
X
X
Patient acceptable symptom state
X
X
X
X
X
If considers treatment failed
X
X
X
X
Motivation - ready to start
exercising (0-10)
X
FIHOA: Functional index for hand osteoarthritis patients. COPD: Chronic obstructive pulmonary disease,
RA: Reumatoid Arthrits, PD: Parkinson’s Disease,, NRS: Numeric Rating Scale