DTx Product Case Study: Kaia Health

Kaia users see an improved ability to self-manage their chronic back pain symptoms

Digital therapeutics deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.

Product Overview

Medical condition:

Chronic, nonspecific low back pain

Target patient population:

People with chronic low back pain and over the age of 18

What to expect:

Kaia users should expect an improved ability to self-manage their chronic back pain symptoms

Clinical
Overview

Indications for use:

The Kaia product is intended for self-management of nonspecific low back pain that has persisted for longer than 4 weeks (subacute and chronic back pain), and for self-management following previous episodes of nonspecific low back pain. People can use the Kaia product with or without current or past supervision from medical professionals, but need to have undergone prior medical examination to exclude causes for back pain that would require specific treatment. The Kaia product is designed to be used directly by laypersons in a home setting without prior training.

Outcomes:

Research demonstrates that Kaia users display a statistically significant lower pain level at a 12-week follow-up than traditional physical therapy coupled with online education

Directions:

Kaia users are encouraged to use the Kaia product regularly, both when symptoms are and aren’t active. The Kaia product is a training program that is intended to aid in the self-management of both pre-chronic and chronic nonspecific low back pain. Back health maintenance requires a continuous lifestyle change, rather than one-time or as-needed use.

Risks & warnings:

Kaia may not be suitable for individuals who are not cleared for physical activity by their physician.

Specifically, users potentially inappropriate for use of Kaia prior to consulting their physician have: potential spinal injury or fracture, decreased bone density, spinal tumor, spinal infection, disc herniation, previous spinal surgery, advanced heart disease, conditions affecting control of the lower body, MSK problems affecting major joints in the lower body, pregnancy, gait imbalance or history of falls, coagulopathy, or history of bleeding event.

Place in therapy:
Complementary to current therapy

Product
Access

Product description:

Kaia is a software program, accessed via an iOS or Android smartphone or tablet. It digitizes and delivers back health tools based on multimodal rehabilitation (MMR), an integrative, evidence-based approach to pain. Kaia also pairs users with accredited health coaches to support them on their journey to back health. MMR is the existing international gold-standard approach for chronic pain.*

Prescription status:

A prescription is not required.

Patient access:

Users receive paid access to Kaia through their health plan or employer, or can be recommended to Kaia by their physician. Once eligible, users receive instructions from Kaia on how to download the Kaia app through the Apple App Store or Google Play. Thereafter, the entire program is facilitated by the Kaia product. Daily training sessions are delivered to users directly via Kaia on their device. Users also interact with their Kaia Coach and/or care managers through the app.

Use of Kaia requires a smartphone or tablet that runs iOS or Android.

Provider access:

Healthcare providers may access the Kaia dashboard to monitor patient usage and clinical outcomes. They can also use data within Kaia to adapt the care plans of their patients. In the future, this data will be available in EHRs.

Coverage options:

Kaia is typically paid for by insurance plans or covered under self-insured employers’ medical benefits policies.

Product availability:

Kaia is available in:

  • EU: Class I low risk medical device, compliant with EU MDD
  • USA: Low risk device compliant with FDA’s Good Manufacturing Practice (GMP) and Quality System guidelines

*Kamper SJ et al., Cochrane systematic review and meta-analysis. The BMJ. 2015;350:h444

Engaging users. Driving outcomes.

Kaia’s proprietary Motion Coach™ feature gives users real-time feedback on their physical exercise performance and form correction. Motion Coach uses the camera already on the user’s device to facilitate proper form and drive engagement.

Clinical
Trials

Study Title: App-based multidisciplinary back pain treatment versus combined physiotherapy plus online education: a randomized controlled trial

Study Design: Independent Randomized Control Trial

Outcomes: Kaia, as a multidisciplinary back pain program, is effective in helping people with lower back pain manage back pain and is superior to physiotherapy in combination with online education about symptoms

Study Title: Implementing Systematically Collected User Feedback to Increase User Retention in a Mobile App for Self-Management of Low Back Pain: Retrospective Cohort Study

Study Design: Observational study

Outcomes: This study indicates that the implementation of systematically collected user feedback during development of updated versions can contribute to improvements in terms of frequency of use and potentially even clinical endpoints such as pain level

Study Title: Treatment of Low Back Pain with a Digital Multidisciplinary Pain Treatment App: Short-Term Results

Study Design: Observational study

Outcomes: This retrospective study showed that in a pre-selected population of product users, an app digitalizing multidisciplinary rehabilitation for the self-management of LBP reduced user-reported pain levels significantly. The observed effect size was clinically relevant. Ongoing prospective RCTs will adjust for potential bias and selection effects.