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

NCT ID: NCT04615377

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-07
• Study Completion Date: 2021-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Kaia hip and knee pain app

Kaia software application: Kaia Knee and Hip pain app (version 2.37.0) The Kaia Knee and Hip pain app is an investigational device, which is intended as a digital aid for the self-management of osteoarthritis for use by adults (between 22 to 75 years old) without supervision by healthcare professionals in a home setting.

Group Type: EXPERIMENTAL

Kaia hip and knee pain application

Intervention Type: BEHAVIORAL

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.

Treatment as usual

Participants will be encouraged to continue the treatment that they have been on without restriction

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between 22 and 75 years old
• Able to speak, read, and understand English
• Able to use an iPad, has internet access at home and a personal email address
• Self-reported diagnosis of OA of knee or hip confirmed by ACR clinical criteria
• Self-reported pain intensity ≥4/10 on Numeric Rating Scale (NRS) for knee and hip pain, on average, in the week prior to screening
• Pain duration ≥1 month
• Willing and capable of providing Informed Consent to use the Kaia Knee and Hip pain app and participate in all assessments associated with this clinical study

Exclusion Criteria

• Referral or plans for surgery, chiropractic care, acupuncture, physical therapy, injections or other treatment for knee or hip pain in the next 3 months following screening
• Self-reported prior subscription to Kaia apps or plans to participate in any other investigational trials or protocols for knee or hip pain
• Prior knee or hip surgery or injury in the last 3 months
• Current workers comp case or litigation related to musculoskeletal pain
• Self-reported use of opioids within 30 days prior to screening
• Self-reported history of substance abuse within the past 1 year
• Self-reported diagnosis of an inflammatory/rheumatologic disease
• Self-reported diagnosis of neuropathic pain disorder or other chronic pain disorder (ex. fibromyalgia, complex regional pain syndrome [CRPS])

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaia Health Software

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin J Choo, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic and Neurosurgery Specialists, 6 Greenwich Office Park, Greenwich, CT 06831

Locations

Choo

Stamford, Connecticut, United States

Countries

United States

Other Identifiers

USOA001

Identifier Type: OTHER

Identifier Source: secondary_id

Kaia US OA Study

Identifier Type: -

Identifier Source: org_study_id