Clinical trial NCT04615377: The Kaia Hip and Knee Pain Intervention for Self-management of the Pain in Patients With Osteoarthritis.
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Lead sponsor: Kaia Health Software
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 192
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \[CRPS\])

Primary outcomes:
measure: 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).
timeFrame: On day 0, 30, 60 and 90
Secondary outcomes:
measure: 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).
timeFrame: On day 0, 30, 60 and 90
measure: 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).
timeFrame: On day 0, 30, 60 and 90
measure: 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).
timeFrame: On day 0, 30, 60 and 90
measure: Patient-Reported Outcomes Measurement Information System (PROMIS Global 10)
timeFrame: Information collected on day 0, 30, 60 and 90
measure: Inclination towards healthcare utilization
timeFrame: Information collected only on day 0
measure: Self-reported number of lost workdays
timeFrame: Information collected only on day 0 and day 90
measure: Pain medication intake
timeFrame: Information collected on day 0, 30, 60 and 90
Other outcomes:
measure: Perceived treatment helpfulness
timeFrame: Study start, On day 0
measure: Satisfaction and perceived treatment helpfulness
timeFrame: Study end, On day 90
measure: Self-reported healthcare utilization
timeFrame: On day 0, 30, 60 and 90
measure: Safety assessment
timeFrame: On day 0, 30, 60 and 90
Locations:
city: Stamford
country: United States
facility: Choo
state: Connecticut
Study officials:
affiliation: Orthopaedic and Neurosurgery Specialists, 6 Greenwich Office Park, Greenwich, CT 06831
name: Kevin J Choo, MD
role: PRINCIPAL_INVESTIGATOR
References: