Health Services AccessibilityAccessNCT06148779
Can Digitally Delivered First-line Osteoarthritis Treatment Improve Equal Access to Care
An observational study of Health Services Accessibility and First-line Treatment, run by Joint Academy at 1 site in Sweden.
Trial summary
To improve chronically ill patients' health and quality of life, long-standing and continuous treatment is needed at an acceptable cost. The purpose of this study was to compare utilization of digital versus face-to-face delivered osteoarthritis (OA) treatment in the 21 different county councils of Sweden that are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Services Accessibility, First-line Treatment, Osteoarthritis
- What is being tested?
- Digitally delivered first-line treatment for osteoarthritis and Face-to-face first-line treatment for osteoarthritis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2022to 31 Jul 2025
- 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
- Adult, Older adult
Study population: Participants with knee or hip OA that have joined 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 and the Better management of patients with OsteoArthritis (BOA) registry.
Who may be able to join
- 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 National Institute for Health and Care Excellence (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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Joint Academy
Malmö
Leif E Dahlberg, Senior Professor
About this study
Official title: Can Digitally Delivered First-line Osteoarthritis Treatment Improve Equal Access to Care in Urban and Rural Areas of Sweden
To improve chronically ill patients' health and quality of life, long-standing and continuous treatment is needed at an acceptable cost. The purpose of this study was to compare utilization of digital versus face-to-face delivered osteoarthritis (OA) treatment in the 21 different county councils of Sweden that are responsible for providing healthcare to the residents.
Read the detailed description
Since 2008 Sweden has had a structured first-line face-to-face knee and hip osteoarthritis (OA) treatment program, Better management of patients with OsteoArthritis (BOA). However, records show that this face-to-face program is underutilized and reaches only a minority of those that would benefit from it.
The first-line OA management program has been transformed into a digital version, Joint Academy® (JA), to facilitate implementation, scaling, increased accessibility, and improved patient adherence. The mobile application (app) consists of video instructions distributed daily with individualized exercises for participants with knee or hip OA, as well as educational information on OA symptoms and self-management based on current international guidelines for the management of OA. Each participant is assigned to a physical therapist available through asynchronous chat and telephone who supervises the participant throughout the whole program.
To improve chronically ill patients' health and quality of life, long-standing and continuous treatment is needed at an acceptable cost. Recent evidence suggests that JA costs 25% compared to the BOA program for three months of treatment. Providing patients with equal access to care necessitates availability in urban and rural areas alike. This can potentially be achieved by digital delivery, but it is yet unknown if digital delivery of first-line OA treatment, compared with face-to-face, improves equal access to care. The purpose of this study was to compare utilization of digital and face-to-face delivered OA treatment in the 21 different county councils of Sweden that are responsible for providing healthcare to the residents.
Method Registered patient participation in the BOA program during 2021-2023 will be retrieved from the BOA Register. The BOA registry. Data from digital program participation was retrieved from the JA database. To be included, a patient need to have registered for the first visit in the BOA registry or have enrolled in the program by answering the first questionnaire in the JA registry.
Population density per county and county size were retrieved from Statistics Sweden. Results were calculated and presented as users per 100 000 residents. Mean and median values as well as standard deviations were calculated separately for registered participants/100 000 for BOA and JA programs, and for regions with more (n=12) or less (n=8) than 20 residents per km2.
Please not that the BOA registry was in January 2023 renamed to The Swedish Osteoarthritis Registry.
- Being tested
- Digitally delivered first-line treatment for osteoarthritis, Face-to-face first-line treatment for osteoarthritis
- Keywords
- Osteoarthritis, Digitally delivered, Tele-health, Physiotherapy, Access to care, Exercise
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally delivered first-line treatment for osteoarthritisBehavioural
Digitally delivered first-line for osteoarthritis through the caregiver Joint Academy.
Face-to-face first-line treatment for osteoarthritisBehavioural
First-line for osteoarthritis delivered at a primary care clinic face-to-face with reported data to the BOA registry.
| Study group | Role | What they receive |
|---|---|---|
| Joint Academy | Not described Receives: Behavioral: Digitally delivered first-line treatment for osteoarthritis | |
| BOA | Not described Receives: Behavioral: Face-to-face first-line treatment for osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postal code/Official Municipality Key
Postal code/Official Municipality Key of participants
Measured: Baseline
Postal code/Official Municipality Key for primary care center
For the BOA group only
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Jan 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services AccessibilityStudies 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
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Academy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University, The Swedish Osteoarthritis Registry
- Responsible party
- Sponsor
- Investigators
- Leif E Dahlberg, Senior professor, Study director, Joint Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148779
- Sponsor's protocol ID
- Access to care OA
- Acronym
- Access
- Status last verified
- Sep 2024
- First submitted
- 20 Nov 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Digitally Delivered First-line Osteoarthritis Treatment Improve Equal Access to Care in Urban and Rural Areas of Sweden
- ClinicalTrials.gov ID
- NCT06148779
- Acronym / sponsor ID
- Access / Access to care OA
- Keywords
- Osteoarthritis, Digitally delivered, Tele-health, Physiotherapy, Access to care, Exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Joint AcademyIndustry (pharma, biotech, devices)
- Collaborators
- Lund University, The Swedish Osteoarthritis Registry
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 28 Nov 2023 (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 improve chronically ill patients' health and quality of life, long-standing and continuous treatment is needed at an acceptable cost. The purpose of this study was to compare utilization of digital versus face-to-face delivered osteoarthritis (OA) treatment in the 21 different county councils of Sweden that are responsible for providing healthcare to the residents.
Detailed description
Since 2008 Sweden has had a structured first-line face-to-face knee and hip osteoarthritis (OA) treatment program, Better management of patients with OsteoArthritis (BOA). However, records show that this face-to-face program is underutilized and reaches only a minority of those that would benefit from it.
The first-line OA management program has been transformed into a digital version, Joint Academy® (JA), to facilitate implementation, scaling, increased accessibility, and improved patient adherence. The mobile application (app) consists of video instructions distributed daily with individualized exercises for participants with knee or hip OA, as well as educational information on OA symptoms and self-management based on current international guidelines for the management of OA. Each participant is assigned to a physical therapist available through asynchronous chat and telephone who supervises the participant throughout the whole program.
To improve chronically ill patients' health and quality of life, long-standing and continuous treatment is needed at an acceptable cost. Recent evidence suggests that JA costs 25% compared to the BOA program for three months of treatment. Providing patients with equal access to care necessitates availability in urban and rural areas alike. This can potentially be achieved by digital delivery, but it is yet unknown if digital delivery of first-line OA treatment, compared with face-to-face, improves equal access to care. The purpose of this study was to compare utilization of digital and face-to-face delivered OA treatment in the 21 different county councils of Sweden that are responsible for providing healthcare to the residents.
Method Registered patient participation in the BOA program during 2021-2023 will be retrieved from the BOA Register. The BOA registry. Data from digital program participation was retrieved from the JA database. To be included, a patient need to have registered for the first visit in the BOA registry or have enrolled in the program by answering the first questionnaire in the JA registry.
Population density per county and county size were retrieved from Statistics Sweden. Results were calculated and presented as users per 100 000 residents. Mean and median values as well as standard deviations were calculated separately for registered participants/100 000 for BOA and JA programs, and for regions with more (n=12) or less (n=8) than 20 residents per km2.
Please not that the BOA registry was in January 2023 renamed to The Swedish Osteoarthritis Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joint Academy | – | Behavioral: Digitally delivered first-line treatment for osteoarthritis |
| BOA | – | Behavioral: Face-to-face first-line treatment for osteoarthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants with knee or hip OA that have joined 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 and the Better management of patients with OsteoArthritis (BOA) registry.
Key inclusion criteria (2 listed)
- 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 National Institute for Health and Care Excellence (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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Digitally delivered first-line treatment for osteoarthritisDigitally delivered first-line for osteoarthritis through the caregiver Joint Academy. | Behavioural | Joint Academy |
| Face-to-face first-line treatment for osteoarthritisFirst-line for osteoarthritis delivered at a primary care clinic face-to-face with reported data to the BOA registry. | Behavioural | BOA |
Primary outcome
Postal code/Official Municipality Key
Time frame: Baseline
Postal code/Official Municipality Key of participants
Postal code/Official Municipality Key for primary care center
Time frame: Baseline
For the BOA group only
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
Related trials for Health Services Accessibility
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Recruiting
Targeted Navigation in Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma, Cholangiocarcinoma
Enrolling by invitation
TimelyCare - A Proactive Primary Care Model: Delivering the Right Care at the Right Time for Individuals at Risk of High Care Consumption
Multimorbidity, Integrated Care
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
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, Senior professor study director
Joint Academy
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 Services Accessibility and First-line Treatment, 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?
The sponsor lists 2 inclusion and 0 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 27 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leif E Dahlberg, Senior professor (+46406550292, leif@jointacademy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postal code/Official Municipality Key (time frame: Baseline). The study lists 2 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 27 Sep 2024.