DTx Product Case Study: Kaia Health
Kaia users see an improved ability to self-manage their chronic back pain symptoms
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
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.
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
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
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.*
A prescription is not required.
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.
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.
Kaia is typically paid for by insurance plans or covered under self-insured employers’ medical benefits policies.
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.
Study Design: Cluster-Randomized Controlled Trial
Outcomes: Compared to three months of standard-of-care treatment (including medication utilization to surgical interventions), Kaia demonstrated twice the level of pain reduction compared to standard-of-care.
Additionally, secondary outcomes (anxiety, depression, stress, wellbeing, and body functionality) showed greater improvement in the Kaia group than standard-of-care patients. Anxiety, depression, stress, and mental wellbeing deteriorated in the control group receiving standard-of-care treatments, while patients in the Kaia group improved on all of four variables.
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 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 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.