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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
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)
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
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.
- First posted30 Aug 2021
- Study start14 Jan 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Why it stopped: Study halted due to unforeseen challenges in securing the necessary resources to conduct the research effectively.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-related Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Joint Academy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Changes in Health Outcomes During Digitally Delivered Exercise and Education Treatment for Hip and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05026580
- Acronym / sponsor ID
- EQ-5D-5L
- Keywords
- Osteoarthritis, Exercise, Digital, Telehealth, Physiotherapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study halted due to unforeseen challenges in securing the necessary resources to conduct the research effectively.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Joint AcademyIndustry (pharma, biotech, devices)
- Collaborators
- Lund University
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint Academy exercise and education smart phone applicationThe 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. | Behavioural | – |
Primary outcome
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Time frame: one year
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)
2 secondary outcomes
Pain assessed with a Numeric Rating Scale (NRS)
Time frame: one year
Physical function with the 30-sec chair stand test (CST)
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.