The Kaia Hip and Knee Pain Intervention for Self-management of the Pain in Patients With Osteoarthritis.
Condition: Knee Osteoarthritis; Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The study intervention provides an innovative way of making exercise training and other
      recommended lifestyle modifications as accessible as possible for knee and hip OA
      participants by introducing a home-based exercise training program with a motion track
      feedback technology. Self-management of the pain for the patients suffering osteoarthritis,
      in the form of lifestyle modification, implementation of coping strategies and exercise is
      part of recommendations of recent international guidelines such as those by the
      Osteoarthritis Research Society International (OARSI). Cost and resource constraints
      typically limit the access to these recommended therapies. Moreover, the study intervention
      is focused on maintaining and adapting everyday physical activity, as required, in comparison
      to the control group.
    

Detailed description: 
      Osteoarthritis (OA) is a painful, degenerative disease of the affected joints. According to
      surveys by the World Health Organization (WHO) knee and hip joint OA is one of the diseases
      that make up the largest proportion of all disability diseases.

      On the individual patient level, there is a pronounced limitation of the quality of life,
      which can also lead to the development of secondary diseases. There are numerous methods
      available for the treatment of OA, the spectrum of which ranges from conservative measures
      such as physical therapy or medical procedures up to surgical procedures, especially joint
      replacement. In recent years, the number of prostheses implanted in knee and hip joints has
      increased significantly.

      International guidelines such as those of the American College of Rheumatologists recommend
      conservative treatment of OA of the knee and hip joint with physical therapy.
      Multidisciplinary approaches include aerobic and anaerobic exercise training, in particular
      with the aim of weight loss in overweight participants, participant education for
      self-management of the disease and the consideration of psychosocial factors. This
      comprehensive, structured, conservative program for the treatment of OA achieves
      significantly better results than the standard treatment. However, comparable programs, which
      offer comprehensive management of OA are not widely available.

      Digital therapies represent a novel approach to help patients manage themselves and their
      diseases in a home setting and even show better results than current standard therapies. An
      analysis of a smartphone intervention providing a multidisciplinary approach for
      self-management of lower back pain, the Kaia Back Pain Relief app, shows promising results in
      180 users with a significant and clinically relevant reduction of pain levels.

      Based on these promising results, this study will evaluate the effectiveness of the Kaia Knee
      and Hip pain app intervention in comparison to usual medical care in reducing pain and
      disease-related symptoms in participants with OA over 3 months.
    

Intervention name(s): Kaia hip and knee pain application; Treatment as usual
Intervention type(s): Behavioral; Other
Intervention description(s): The Kaia Knee and Hip pain app software, when loaded onto a smartphone, recommends to the participant specific exercises for the lower extremity. Using the camera on a smartphone, the software then tracks the participant's movements as the participant performs the exercises, analyzes those movements using machine learning, and provides audio-visual feedback to the participant. The exercise therapy is augmented by educational content and cognitive behavioral therapy to provide a multidisciplinary approach to self-management of osteoarthritis. Behavioral Health Coaches ensure participant motivation throughout the program based on a predefined curriculum.; Participants allocated to the control arm will be advised to continue receiving treatment as usual ( standard care) without restrictions, except participation in other investigational trials, and will likewise be followed up for 90 days. Apart from that, they are encouraged to seek care, as they would do normally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment