Osteoarthritis Outcomes in Different Ages

NCT05208463 | Completed

• 1 other identifier: JA ages study
• Study Type: observational
• Target: 14,610
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to study if there are differences in outcomes between different age groups for persons with knee or hip osteoarthritis during treatment in digitally delivered exercise and education treatment.

Conditions

Pain; Physical Function; Age

Keywords

Pain; Osteoarthritis; Knee; Hip; Exercise; Digital; Tele-health; Older adults

Outcome Measures

Primary Outcomes (2)

• Pain assessed with a Numeric Rating Scale (NRS)

  A 11-point Likert scale with the question: 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

  Change from baseline to 3 months

• 30-sec chair stand test (CST)

  Number of chair rises on 30 seconds 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

  Change from baseline to 3 months

Secondary Outcomes (7)

• KOOS-12 questionnaire

  Change from baseline to 3 months

• HOOS-12 questionnaire

  Change from baseline to 3 months

• KOOS-PS questionnaire

  At 3 months

• Fear of movement

  Change from baseline to 3 months

• Walking difficlties

  Change from baseline to 3 months

Interventions

Joint Academy BEHAVIORAL

Digitally deliverd exercise and education first line treatment for hip and knee osteoarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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. Outcome analysis will be made for two separate sub-samples; one repeated cross-sectional with all available participants with data at baseline and/or 3, 6, (9), and 12 month (+- 6 weeks) and one longitudinal sample including those who had data at baseline and at 12 months with ≥1follow-up in between. If enough patients we will include follow up until 24 month.

* 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)

Arthro Therapeutics

Malmo, Sweden

Location

MeSH Terms

Conditions

Pain; 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 Officials

• Leif E Dahlberg, Senior professor

  Arthro Therapeutics

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 26, 2022
• Study Start: January 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available when the paper has been submitted and accepted for publication and up to two years after that. Original data in coded form and logging of performed analyzes will be accessible for 10 years after they were collected.
• Access Criteria: Researchers can ask for access through contacting medical director and responsible researcher at Joint Academy.

Locations

SE (1)