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

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).

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Intervention / Treatment: Behavioral: Kaia hip and knee pain application; Other: Treatment as usual

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Choo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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])

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
ACTIVE_COMPARATOR: Treatment as usual; Participants will be encouraged to continue the treatment that they have been on without restriction	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	To evaluate the change from baseline by Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS) and derive the pain score for the Western Ontario and McMaster Universities Osteoarthritis Index pain sub-scale through Week 12 i.e pain score domain (mean of changes in the 5 pain related items) on HOOS or KOOS. 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
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).	To evaluate the change from baseline by Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS) and derive the Functionality index as for the Western Ontario and McMaster Universities Osteoarthritis functionality sub-scale through Week 12 i.e pain score domain (mean of changes in the 5 pain related items) on HOOS or KOOS. 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
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).	To evaluate the change of stiffness from baseline, by Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS), and derive the stiffness index score as for the Western Ontario and McMaster Universities Osteoarthritis stiffness sub-scale, through Week 12 i.e stiffness score domain (mean of changes in the 5 pain related items) on HOOS or KOOS. 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
Patient-Reported Outcomes Measurement Information System (PROMIS Global 10)	Overall change in the Quality of life score assessed by the PROMIS Global 10 questionnaire from baseline to the week 12.	Information collected on day 0, 30, 60 and 90
Inclination towards healthcare utilization	Self-reported inclination towards healthcare utilization on an 11-point Likert scale. Where (0) means none and (11) means Extreme.	Information collected only on day 0
Self-reported number of lost workdays	Self-reported number of lost workdays in the month prior to enrolment and during study observational period (assessed at baseline day 0, day 30, day 60, and day 90)	Information collected only on day 0 and day 90
Pain medication intake	Pain medication intake 30 days prior to enrolment and during study period.	Information collected on day 0, 30, 60 and 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived treatment helpfulness	Feedback on the mobile medical application (5-Point Likert Scales ranging from 1 "lowest satisfaction" to 5 "highest satisfaction")	Study start, On day 0
Satisfaction and perceived treatment helpfulness	Feedback on the mobile medical application (5-Point Likert Scales ranging from 1 "lowest satisfaction" to 5 "highest satisfaction")	Study end, On day 90
Self-reported healthcare utilization	Use of services by persons for the purpose of preventing and curing health problems (type and number of times utilized)	On day 0, 30, 60 and 90
Safety assessment	The safety of the usage of the Kaia Knee and Hip pain app is evaluated by the incidence of reported adverse events in the intervention and control arm.	On day 0, 30, 60 and 90

Collaborators and Investigators

• Sponsor: Kaia Health Software
• Investigators: Principal Investigator: Kevin J Choo, MD, Orthopaedic and Neurosurgery Specialists, 6 Greenwich Office Park, Greenwich, CT 06831

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2021
• Primary Completion (ACTUAL): July 31, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (ACTUAL): November 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: Kaia US OA Study; USOA001 (OTHER: Kaia Health Software, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No