Osteoarthritis, KneeNCT05316194
Minimal Clinically Important Changes in Osteoarthritis Treatment
An observational study of Osteoarthritis, Knee and Osteoarthritis, Hip, run by Joint Academy at 1 site in Sweden.
Trial summary
To assess minimal clinically important change, cut-offs for treatment failure and patient acceptable symptom state for pain and patient-reported function and quality of life in persons with hip or knee osteoarthritis, participating in digitally delivered first-line education and exercise treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Digital treatment for hip and knee osteoarthritis
- How many people
- 11,708 participants
- Where
- 1 siteSweden
- Study dates
- 6 Jun 2018to 1 Jul 2021
- 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 care provider. 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.
Data for all participants enrolled in the program until May 2022, and have given their written informed consent, will be extracted from the digital treatment register.
Inclusion criteria will be; i) diagnosed hip or knee OA ii) provided answer for KOOS/HOOS questionnaires and/or NRS pain at baseline and any of the follow-ups, i.e., 3, 6, 9 and/or 12 months.
Exclusion criteria: none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimal Clinically Important Changes in Digitally Delivered Osteoarthritis Treatment
To assess minimal clinically important change, cut-offs for treatment failure and patient acceptable symptom state for pain and patient-reported function and quality of life in persons with hip or knee osteoarthritis, participating in digitally delivered first-line education and exercise treatment.
Read the detailed description
Patient-reported outcome measures (PROMs) are consistently recommended as the primary end-point in clinical trials evaluating treatment effects in different medical conditions. For a meaningful interpretation of the PROMs used, three different approaches have been proposed; The Minimal Important Change (MIC), which is the smallest change in scores that represents an important improvement for the patient, i.e., the patient is feeling better, the Patient Acceptable Symptom State (PASS), which represents patients that consider their current status as acceptable, i.e., the patient is feeling good and Treatment Failure (TF), which represents patients that consider their state so unsatisfactory that they think the treatment has failed, all based on relevant anchor questions. Previous research in patients with anterior cruciate ligament (ACL) injury and femoroacetabular impingement reveals that feeling better is not necessarily the same as feeling good and reporting only the MIC (or mean change) may overestimate the results, stressing the need for including different measures of improvement to evaluate treatment effects on PROMs. The MIC, PASS and TF for persons undergoing digital treatment for hip or knee osteoarthritis are not yet determined. In this retrospective register-based study we will define MIC, PASS and TF in pain and patient-reported function and quality of life, using anchor-based questions, for persons participating in digital first-line treatment for hip and knee OA. In addition, we will use these thresholds to establish the proportion of patients reaching MIC and/or PASS or reporting TF, separate for persons with hip and knee OA.
Statistical analysis:
For MIC calculations, participants will be categorized as "importantly improved" if they answered "Better an important improvement" or "Somewhat better but enough to be an important improvement" to the anchor questions for KOOS/HOOS and NRS. MIC for an important improvement will then be calculated using the predictive modeling method (MICpred), adjusting for the proportion of improved patients.
The MICpred method will also be used to calculate the post score (i.e., 3, 6, 9 and 12 months) for KOOS/HOOS-scores and NRS-scores for participants that have responded "Yes" to the PASS or TF anchor question, respectively. The proportion of participants reaching the cut-offs of MIC, PASS and TF for the KOOS/HOOS and NRS, will then be calculated separately for participants with knee and hip OA.
Subgroup analyses on the effect of sex, age and baseline symptoms (depending on data distribution to ensure we will have an adequated sample size also in subgroups) on MIC, PASS and TF will also be performed using the MICpred method
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Digital treatment for hip and knee osteoarthritis
- Keywords
- Osteoarthritis, Minimal Clinically Important Change, Responder, Exercise, Telehealth, Digital, Knee, Hip, Treatment failure, Patient acceptable symptom state
- Medical subject headings
- 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.
Digital treatment for hip and knee osteoarthritisOther
The program is an app-based version of the Swedish face-to-face management program for OA "Better management of patients with OsteoArthrits" and includes weekly educational sessions, individualized exercises and a possibility to chat asynchronously with a physical therapist during the entire duration of the program.
| Study group | Role | What they receive |
|---|---|---|
| Participation in digital OA treatment | All participants that have participated in a digitally delivered first-line treatment program (Joint Academy) for hip or knee OA until May 2022. Receives: Other: Digital treatment for hip and knee osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint pain
Joint pain will be measured with the NRS-scale. NRS comprises an 11-point scale where 0 indicates no pain and 10 indicates the worst possible pain during the last week
Measured: 3 - 12 months
KOOS/HOOS-12
The Knee injury and Osteoarthritis Outcome Score (KOOS-12)(knee OA) and the Hip injury and Outcome Score (HOOS)(hip OA) will be used for evaluating knee/hip function and quality of life. The KOOS/HOOS-12 are short versions of the original KOOS/HOOS questionnaires and includes 12 items measuring knee/hip pain, physical function and knee/hip-related quality of life. All items are scored from 0-4. The scores will then be normalized to a score from 0-100 for each domain (pain, function and quality of life) as well as a total score of all three domains where 0 indicates extreme problems and 100 indicates no problems.
Measured: 3-12 months
MIC
The MIC associated with KOOS/HOOS-12/NRS scores will be calculated using domain specific anchor questions; NRS and KOOS/HOOS pain: How is your joint pain now compared with prior to your participation in the treatment? KOOS/HOOS function: How is your ability to perform daily activities now, compared with prior to your participation in the treatment? (sitting, standing, walking, stairs, putting on/taking off socks, household work)? KOOS/HOOS QoL: How is your quality of life in relation to your knee now, compared with prior to your participation in the treatment? (trust in knee, lifestyle, how often you think of your knee)? With the following response option; Better, an important improvement/ Somewhat better but enough to be an important improvement/ Very small change, not enough to be an important improvement/About the same/Very small change, not enough to be an important deterioration/Somewhat worse, but enough to be an important deterioration/Worse, an important deterioration
Measured: 3 - 12 months
Patient acceptable symtom state (PASS)
The following question will be asked (yes/no); Considering your knee/hip function, do you feel that your current state is satisfactory? You should take all activities during your daily life, sport and recreational activities, your level of pain and other symptoms, and also your knee/hip- related quality of life into account.
Measured: 3 - 12 months
Treatment failed (TF)
The following question will be asked (yes/no): If you answered "No" to the previous question, would you consider your current function as being so unsatisfactory that you think the treatment has failed?
Measured: 3 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start6 Jun 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- 11,708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Academy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Leif E Dahlberg, Study director, Arthro Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316194
- Sponsor's protocol ID
- MIC in OA
- Status last verified
- Jan 2024
- First submitted
- 30 Mar 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared between the researchers working with this project. According to the European General Data Protection Regulation (GDPR) we cannot legally share IPD outside of this project.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Clinically Important Changes in Digitally Delivered Osteoarthritis Treatment
- ClinicalTrials.gov ID
- NCT05316194
- Acronym / sponsor ID
- MIC in OA
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Osteoarthritis, Minimal Clinically Important Change, Responder, Exercise, Telehealth, Digital, Knee, Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,708 participants (actual)
- Lead sponsor
- Joint AcademyIndustry (pharma, biotech, devices)
- Collaborators
- Lund University
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 7 Apr 2022 (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.
To assess minimal clinically important change, cut-offs for treatment failure and patient acceptable symptom state for pain and patient-reported function and quality of life in persons with hip or knee osteoarthritis, participating in digitally delivered first-line education and exercise treatment.
Detailed description
Patient-reported outcome measures (PROMs) are consistently recommended as the primary end-point in clinical trials evaluating treatment effects in different medical conditions. For a meaningful interpretation of the PROMs used, three different approaches have been proposed; The Minimal Important Change (MIC), which is the smallest change in scores that represents an important improvement for the patient, i.e., the patient is feeling better, the Patient Acceptable Symptom State (PASS), which represents patients that consider their current status as acceptable, i.e., the patient is feeling good and Treatment Failure (TF), which represents patients that consider their state so unsatisfactory that they think the treatment has failed, all based on relevant anchor questions. Previous research in patients with anterior cruciate ligament (ACL) injury and femoroacetabular impingement reveals that feeling better is not necessarily the same as feeling good and reporting only the MIC (or mean change) may overestimate the results, stressing the need for including different measures of improvement to evaluate treatment effects on PROMs. The MIC, PASS and TF for persons undergoing digital treatment for hip or knee osteoarthritis are not yet determined. In this retrospective register-based study we will define MIC, PASS and TF in pain and patient-reported function and quality of life, using anchor-based questions, for persons participating in digital first-line treatment for hip and knee OA. In addition, we will use these thresholds to establish the proportion of patients reaching MIC and/or PASS or reporting TF, separate for persons with hip and knee OA.
Statistical analysis:
For MIC calculations, participants will be categorized as "importantly improved" if they answered "Better an important improvement" or "Somewhat better but enough to be an important improvement" to the anchor questions for KOOS/HOOS and NRS. MIC for an important improvement will then be calculated using the predictive modeling method (MICpred), adjusting for the proportion of improved patients.
The MICpred method will also be used to calculate the post score (i.e., 3, 6, 9 and 12 months) for KOOS/HOOS-scores and NRS-scores for participants that have responded "Yes" to the PASS or TF anchor question, respectively. The proportion of participants reaching the cut-offs of MIC, PASS and TF for the KOOS/HOOS and NRS, will then be calculated separately for participants with knee and hip OA.
Subgroup analyses on the effect of sex, age and baseline symptoms (depending on data distribution to ensure we will have an adequated sample size also in subgroups) on MIC, PASS and TF will also be performed using the MICpred method
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participation in digital OA treatment | – | Other: Digital treatment for hip and knee osteoarthritisAll participants that have participated in a digitally delivered first-line treatment program (Joint Academy) for hip or knee OA until May 2022. |
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 care provider. 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.
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 |
|---|---|---|
| Digital treatment for hip and knee osteoarthritisThe program is an app-based version of the Swedish face-to-face management program for OA "Better management of patients with OsteoArthrits" and includes weekly educational sessions, individualized exercises and a possibility to chat asynchronously with a physical therapist during the entire duration of the program. | Other | Participation in digital OA treatment |
Primary outcome
Joint pain
Time frame: 3 - 12 months
Joint pain will be measured with the NRS-scale. NRS comprises an 11-point scale where 0 indicates no pain and 10 indicates the worst possible pain during the last week
KOOS/HOOS-12
Time frame: 3-12 months
The Knee injury and Osteoarthritis Outcome Score (KOOS-12)(knee OA) and the Hip injury and Outcome Score (HOOS)(hip OA) will be used for evaluating knee/hip function and quality of life. The KOOS/HOOS-12 are short versions of the original KOOS/HOOS questionnaires and includes 12 items measuring knee/hip pain, physical function and knee/hip-related quality of life. All items are scored from 0-4. The scores will then be normalized to a score from 0-100 for each domain (pain, function and quality of life) as well as a total score of all three domains where 0 indicates extreme problems and 100 indicates no problems.
MIC
Time frame: 3 - 12 months
The MIC associated with KOOS/HOOS-12/NRS scores will be calculated using domain specific anchor questions; NRS and KOOS/HOOS pain: How is your joint pain now compared with prior to your participation in the treatment? KOOS/HOOS function: How is your ability to perform daily activities now, compared with prior to your participation in the treatment? (sitting, standing, walking, stairs, putting on/taking off socks, household work)? KOOS/HOOS QoL: How is your quality of life in relation to your knee now, compared with prior to your participation in the treatment? (trust in knee, lifestyle, how often you think of your knee)? With the following response option; Better, an important improvement/ Somewhat better but enough to be an important improvement/ Very small change, not enough to be an important improvement/About the same/Very small change, not enough to be an important deterioration/Somewhat worse, but enough to be an important deterioration/Worse, an important deterioration
Patient acceptable symtom state (PASS)
Time frame: 3 - 12 months
The following question will be asked (yes/no); Considering your knee/hip function, do you feel that your current state is satisfactory? You should take all activities during your daily life, sport and recreational activities, your level of pain and other symptoms, and also your knee/hip- related quality of life into account.
Treatment failed (TF)
Time frame: 3 - 12 months
The following question will be asked (yes/no): If you answered "No" to the previous question, would you consider your current function as being so unsatisfactory that you think the treatment has failed?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No. IPD will only be shared between the researchers working with this project. According to the European General Data Protection Regulation (GDPR) we cannot legally share IPD outside of this project.
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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.
Leif E Dahlberg study director
Arthro Therapeutics
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 Osteoarthritis, Knee and Osteoarthritis, Hip, 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: finished, as of the sponsor's last update on 17 Jan 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Joint pain (time frame: 3 - 12 months). The study lists 5 primary outcomes in all. 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 17 Jan 2024.