Outcomes During Digitally Delivered Osteoarthritis Treatment

NCT05026580 | Withdrawn

• 1 other identifier: EQ-5D-5L
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Health-related Quality of Life; Pain; Function; Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Osteoarthritis; Exercise; Digital; Telehealth; Physiotherapy

Outcome Measures

Primary Outcomes (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)

  one year

Secondary Outcomes (2)

• Pain assessed with a Numeric Rating Scale (NRS)

  one year

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

  one year

Interventions

Joint Academy exercise and education smart phone application BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Joint Academy: lead
• Lund University: collaborator

Study Sites (1)

Joint Academy

Malmo, Skåne County, Sweden

Location

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 30, 2021
• Study Start: January 14, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

SE (1)