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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06148779
Other study ID # Access to care OA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date July 31, 2024

Study information

Verified date March 2024
Source Joint Academy
Contact Leif E Dahlberg, Senior professor
Phone +46406550292
Email leif@jointacademy.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 responsible for providing healthcare to the residents.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50000
Est. completion date July 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility * Patients in the Joint Academy database that had participated in the Joint Academy treatment program for OA and given their informed consent to participate in research. Inclusion criteria for the treatment program: - 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.

Study Design


Intervention

Behavioral:
Digitally delivered first-line treatment for osteoarthritis
Digitally delivered first-line for osteoarthritis through the caregiver Joint Academy.
Face-to-face first-line treatment for osteoarthritis
First-line for osteoarthritis delivered at a primary care clinic face-to-face with reported data to the BOA registry.

Locations

Country Name City State
Sweden Joint Academy Malmö

Sponsors (3)

Lead Sponsor Collaborator
Joint Academy Lund University, The Swedish Osteoarthritis Registry

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postal code/Official Municipality Key Postal code/Official Municipality Key of participants Baseline
Primary Postal code/Official Municipality Key for primary care center For the BOA group only Baseline
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