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

NCT04615377 | Completed

• 2 other identifiers: Kaia US OA StudyUSOA001
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index as calculated from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).

  The primary endpoint is to evaluate the change in the Western Ontario and McMaster Universities Osteoarthritis Index as calculated from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).This change will be calculated over day 0 until week 12. Where the higher scores on the HOOS and KOOS indicate worse pain, stiffness, and functional limitations. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

  On day 0, 30, 60 and 90

Secondary Outcomes (7)

• Pain index as in western Ontario and McMaster's Osteoarthritis Index as derived from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).

  On day 0, 30, 60 and 90

• Functionality index as in western Ontario and McMaster's Osteoarthritis Index as derived from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).

  On day 0, 30, 60 and 90

• Stiffness score as in western Ontario and McMaster's Osteoarthritis Index as derived from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).

  On day 0, 30, 60 and 90

• Patient-Reported Outcomes Measurement Information System (PROMIS Global 10)

  Information collected on day 0, 30, 60 and 90

• Inclination towards healthcare utilization

  Information collected only on day 0

Other Outcomes (4)

• Perceived treatment helpfulness

  Study start, On day 0

• Satisfaction and perceived treatment helpfulness

  Study end, On day 90

• Self-reported healthcare utilization

  On day 0, 30, 60 and 90

Study Arms (2)

Kaia hip and knee pain app

EXPERIMENTAL

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.

Behavioral: Kaia hip and knee pain application

Treatment as usual

ACTIVE COMPARATOR

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

Other: Treatment as usual

Interventions

Kaia hip and knee pain application 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.

Kaia hip and knee pain app

Treatment as usual 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.

Treatment as usual

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \[CRPS\])

Sponsors & Collaborators

• Kaia Health Software: lead

Study Sites (1)

Choo

Stamford, Connecticut, 06905, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kevin J Choo, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 4, 2020
• Study Start: January 7, 2021
• Primary Completion: July 31, 2021
• Study Completion: September 30, 2021
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)