AzTrials
AzTrials

Health-related Quality of LifeNCT05026580

Outcomes During Digitally Delivered Osteoarthritis Treatment

An observational study of Health-related Quality of Life and Pain, run by Joint Academy at 1 site in Sweden.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Objectives: To examine changes in health-related quality of life (HRQL), pain and function among patients with knee or hip osteoarthritis (OA) participating in digitally delivered exercise and education treatment for up to 12 or 24 month. Design: An observational longitudinal and repeated cross-sectional cohort study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Health-related Quality of Life, Pain, Function
What is being tested?
Joint Academy exercise and education smart phone application
How many people
0 participants
Where
1 siteSweden
Study dates
14 Jan 2022to 30 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants join the digital OA treatment program via online advertisements and campaigns placed on search engines and social networks, or by recommendations by their local physiotherapist or orthopaedic surgeon. Procedure for inclusion and exclusion has been described above. Data will be extracted from the Joint Academy (JA) database registry for Swedish patients who had started their treatment Janurary 1st 2019 or after. A Outcome analysis will be made for three different age groups.

  • Patients that had participated in the Joint Academy treatment program and given their informed consent
  • Radiographic and or clinical diagnosis of hip or knee OA from a physical therapist or physician (95% of all patients in previously published studies). Individuals without a prior diagnosis had clinical OA confirmed by an orthopaedic surgeon or physiotherapist via telephone (diagnosis according to NICE criteria and Swedish National Guidelines, and confirming the absence of any red flag symptoms), or if deemed necessary were recommended to seek face-to-face care before inclusion in the programme.
  • From October 1st 2021, all patients should have undergone a physical examination by doctor or physiotherapists before being able to enter the treatment.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Joint Academy

    Malmö, Skåne County

Other trials in Sweden

About this study

Official title: Long-term Changes in Health Outcomes During Digitally Delivered Exercise and Education Treatment for Hip and Knee Osteoarthritis

Objectives: To examine changes in health-related quality of life (HRQL), pain and function among patients with knee or hip osteoarthritis (OA) participating in digitally delivered exercise and education treatment for up to 12 or 24 month.

Design: An observational longitudinal and repeated cross-sectional cohort study.

Read more

Investigators will include participants who have participated in the digitally delivered exercise and education treatment program Joint Academy® for 3, 6 , 9 , 12 and if enough patients also for 24 month. Investigators will analyze both cross-sectional samples at each time point and a longitudinal sample that have participated for at least 12 month, with at least one follow-up in between.

Outcomes: Investigators will analyze HRQL with EQ-5D-5L, pain with Numeric Rating Scale (NRS) 0-10 (best to worst) and function with 30-sec chair stand test (CST) at baseline and at 3, 6, 9,12 and if possible 24 months during the treatment. Main outcome will be change in level in EQ-5D-5L dimensions. We will also analyze minimally clinical important changes (improved or not) and mean changes in EQ-5D-5L index score, pain and 30-sec chair stand test (CST). Logistic regression models and linear mixed models will be used for analysis. Analyses will be performed for repeated cross-sectional samples and a longitudinal sample.

Read the detailed description

International treatment guidelines recommend exercise, education and weight control (if needed) as first-line treatment for knee and hip osteoarthritis (OA). Still, evidence suggest that less than 50% of OA patients have participated in first-line treatment before getting joint replacement.

Several observational and randomised controlled trials (RCTs) show that exercise therapy is effective in reducing pain, improving physical function and health-related quality of life (HRQL) at clinically important levels in the short-term.

Quality of life is rated lower by people with OA compared to norm populations and measures of well-being are increasingly used as outcomes in health interventions. Face-to-face first-line OA treatment following the Better Care for persons with OsteoArthritis (BOA) or Good Life with osteoArthritis in Denmark (GLA:D) initiatives seem to have small but clinically significant effects on HRQL immediate after intervention, at six month and with maintained improvements at one year for knee but not hip OA.

The digitally delivered first-line OA treatment program Joint Academy® (JA) was developed in Sweden in 2016 in an attempt to improve implementation and adherence to guidelines. The program is based on evidence from BOA. Initial observational studies show that both patients with hip and knee OA had clinically important improvements in pain and function at six weeks with sustained improvements up to 48 weeks of treatment. Further, HRQL dimensions mobility and pain/discomfort significantly improved after six weeks, while others did not (self-care, usual activities, and anxiety/depression. However, the long-term change in HRQL during digitally delivered first-line OA treatment is not known.

Therefore, the aim is to identify changes in HRQL, pain and function, during up to12 months of digitally delivered first-line treatment. A second aim was to examine if changes differs between hip/knee and women/men.

Outcomes Outcomes were collected at start and at standardized time points during the treatment. They were chosen based on the International Consortium for Health Outcomes Measurement Standard Set for Hip \& Knee Osteoarthritis (ICHOM), self-entered using the digital program interface and stored in the JA database.

HRQL was evaluated every third month using the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L), which is a generic quality of life measurement tool. The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The levels of severity range from no problems (1) to extreme problems/unable to (5) and are recorded for each of the five dimensions. The raw scores are also converted to a single EQ-5D index value using a scoring algorithm (British tariff was used) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state). A change of ≥0.03 in the index was considered as minimally clinical important change (MCIC) according to a comprehensive review of musculoskeletal disorders.

Joint pain was assessed using the Numerical Rating Scale (NRS), with the instruction Mark on this scale how much pain you had the last week in your hip/knee, followed by a 0-10 scale where 0 indicates No pain and 10 indicates Maximum pain. A difference of 15 of 100 for absolute improvement (slightly or moderately) is considered as MCIC.

Physical function was assessed with the 30-s chair-stand test (CST) performed by the participant with the help of an instruction video with a coupled visual timer. The patient entered the performed number of repetitions after each test. The 30-s CST is recommended by the Osteoarthritis Research Society International (OARSI) as a performance-based functional test for knee and hip OA (Dobson 2013). A difference of two rises is considered as MCIC.

Data on the participants' overall health and characteristics such as OA location (hip/knee), age, sex, educational level (), height, weight and medical conditions (xx) were collected at inclusion.

Being tested
Joint Academy exercise and education smart phone application
Keywords
Osteoarthritis, Exercise, Digital, Telehealth, Physiotherapy
Medical subject headings
Pain, Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Joint Academy exercise and education smart phone applicationBehavioural

    The Joint Academy® (www.jointacademy.com) program for people with hip or knee OA consists of video instructed and progressively adaptable daily exercises, patient education through text lessons and a continuous asynchronous chat function with a personal reg. physiotherapist who supervises the patient during the full participation period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The levels of severity for each dimension ranges from no problems (1) to extreme problems/unable to perform. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)

    Measured: one year

Secondary outcomes (2)
  1. Pain assessed with a Numeric Rating Scale (NRS)

    Mark on this scale how much pain you had the last week in your hip/knee, followed by a 0-10 scale where 0 indicates No pain and 10 indicates Maximum pain

    Measured: one year

  2. Physical function with the 30-sec chair stand test (CST)

    The test is is the maximum number of repetitions of chair rises the participant can perform in 30 secords. It is performed by the participant with the help of an instruction video with a coupled visual timer

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2021
  2. Study start14 Jan 2022
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Why it stopped: Study halted due to unforeseen challenges in securing the necessary resources to conduct the research effectively.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05026580
Sponsor's protocol ID
EQ-5D-5L
Status last verified
Sep 2024
First submitted
24 Aug 2021
Last updated
2 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Health-related Quality of Life and Pain, run by Joint Academy at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in