NCT04615377

The Kaia Hip and Knee Pain Intervention for Self-management of the Pain in Patients With Osteoarthritis.

The Kaia hiP and Knee paIn Digital Application as an interVention for Self-management of Pain in Patients With OsteoarThritis - a Randomised Controlled Study (Kaia PIVOT Study).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Kaia Health Software · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis
• Hip Osteoarthritis

Interventions

Type	Name	Description
BEHAVIORAL	Kaia hip and knee pain application	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.
OTHER	Treatment as usual	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.

Timeline

• Start date: 2021-01-07
• Primary completion: 2021-07-31
• Completion: 2021-09-30
• First posted: 2020-11-04
• Last updated: 2022-08-16

Locations

1 site across 1 country: United States