Product Highlight
Condition targeted:
Cancer care
How it works:
HCP invites a patient to join Kaiku Health where they can report symptoms, receive self-care instructions, education and communicate with the care team. HCP then receives the symptom reports and prioritized alerts through the Kaiku Health platform and can follow up with the whole patient population.
Impact:
Kaiku Health clinical benefits approved by a notified body in Europe include earlier detection of symptoms, signs and/or relapse.
Product Overview
Medical condition:
Cancer care
Target patient population:
Kaiku Health should only be used by people aged 18 years or older. People who are older than 15 years may use Kaiku Health if they are judged by the clinical team to be capable of using it.
What to expect:
Kaiku Health can support treatment decisions and diagnoses through earlier detection of symptoms, signs and/or relapse.
Note: for more information, please visit https://kaikuhealth.com/.
Clinical Overview
Indications for use:
- Outside the United States and Canada, the intended purpose of Kaiku Health is:
“Kaiku Health is intended for use in cancer care and follow-up for non-urgent communication between an adult patient and a medical professional and for collecting patient-reported data, displaying and analysing clinical and patient-reported data, and instructing the patient. The data processed by Kaiku Health are intended to be used in supporting treatment decisions and in supporting diagnoses.”
- In the United States and Canada, the intended use of Kaiku Health is:
“Kaiku Health is intended for use in cancer care and follow-up for non-urgent communication between an adult patient and a medical professional and for collecting patient-reported data, displaying and analyzing clinical and patient-reported data, and instructing the patient. The data processed by Kaiku Health are intended to be used as a part of routine clinical practice in order to support effective symptom management.”
Outcomes:
Kaiku Health enables follow-up patients with cancer and enables comprehensive capturing of symptoms over long periods with good patient adherence and satisfaction.
Directions:
Kaiku Health supports patients between treatment visits and after their treatment has ended. With Kaiku, patients can quickly report potential symptoms they may be experiencing and receive self-care instructions as needed. In addition, patients may send messages to their care team through Kaiku Health. Electronic monitoring allows the healthcare team to treat patients in the best possible way and to gather valuable information for developing treatments.
Risks & warnings:
Contraindications: Any physical or cognitive condition that according to clinical judgement would prevent the patient from using Kaiku Health, e.g. dementia.
Kaiku Health is not monitored in real-time by the clinical staff; it is intended only for non-urgent communication. In urgent situations, contact your care unit or emergency number by phone.
In some special cases the guidance and self-care instructions that Kaiku Health provides might not apply to you. If you have any questions regarding your care, or your symptoms and their management, we kindly ask you to contact your care team.
If you do not receive a response from your care unit within reasonable time, please contact the care unit via phone.
Risks related to confidentiality, integrity, and availability of the personal data processed by Kaiku Health cannot be completely eliminated. If you suspect that your personal data has been compromised, please contact Kaiku Health support.
Place in therapy:
Complementary to current therapy.
Product Access
Product description:
Kaiku Health Ltd provides a product that monitors patient-reported outcomes, providing intelligent symptom tracking and management for healthcare providers in routine oncology care and studies.
Prescription status:
A prescription is not required.
Patient access:
Patients access Kaiku Health through their web browser or download the app on the Apple or Google App store. Patients are able to register upon receiving an invitation to the solution from their healthcare provider.
Use of Kaiku Health for patients requires access to:
- Internet or wifi
- A desktop computer and/or mobile device (smartphone or tablet)
Provider access:
Healthcare providers may access incoming patient reports, patient histories, messages (if applicable) and patient comparison charts through their own interface in Kaiku Health. Kaiku Health also supports integration with EHR systems via the FHIR and HL7 standards.
Coverage options:
Kaiku Health is free to use for patients.
Product availability:
Kaiku Health is available in:
- EU: CE-marked Class IIa medical device
- USA: Medical device that falls under FDA’s enforcement discretion
- Australia, New Zealand and Canada: Class I medical device
- South Africa: Registered as a medical device
- Argentina, Mexico and Japan: Not regulated by medical device regulation
Unique Features
Kaiku Health is a patient’s companion throughout different phases of therapy. It reduces uncertainty around symptoms by educating patients on their self-management strategies. Kaiku offers improved symptom management for care teams and captures real world data on the effectiveness of therapies for cancer research. Kaiku Health has also developed capabilities of predicting the development and progress of cancer patients’ symptoms using Machine Learning.
Clinical Trials
The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.
- Study Title: ePRO symptom follow-up of colorectal cancer patients receiving oxaliplatin-based adjuvant chemotherapy is feasible and enhances the quality of patient care: a prospective multicenter study
Study Design: Prospective multicenter study
Outcomes: The feasibility of the ePRO follow-up was good with 98% reporting easy usage and 86% improved care, while health care personnel valued the easy use and logical workflow. In the ePRO cohort, 42% needed a phone call before planned chemotherapy cycles, while this was 100% in the retrospective cohort (p = 1.4e−8). Peripheral sensory neuropathy was detected significantly earlier with ePRO followed (p = 1e−5) but did not translate to earlier dose reduction, delays, or unplanned therapy termination compared to the retrospective cohort. - Study Title: Follow-Up of Cancer Patients Receiving Anti-PD-(L)1 Therapy Using an Electronic Patient-Reported Outcomes Tool (KISS): Prospective Feasibility Cohort Study
Study Design: Prospective feasibility cohort study
Outcomes: The results of this study suggest that follow-up of cancer patients using ePROs is feasible, enabling comprehensive capturing of symptoms over long periods with good patient adherence and satisfaction. Based on the patient experience surveys, the system was easy to use, and patients felt that ePRO follow-up improved their cancer care. - Study Title: Digital Monitoring and Management of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Treated With Cancer Immunotherapy and Its Impact on Quality of Clinical Care: Interview and Survey Study Among Health Care Professionals and Patients
Study Design: Proof-of-concept pilot study
Outcomes: At the end-of-study survey (N=48: 19 [40%] nurses, 8 [17%] physicians, and 21 [44%] patients), most respondents agreed that the tool facilitated more efficient and focused discussions between patients and HCPs and allowed HCPs to tailor discussions with patients. The standalone tool was well integrated into HCP daily clinical workflow, enabled workflow optimization between physicians and nurses, and saved time by decreasing phone consultations and patient visits.
Note: for more research, please visit https://kaikuhealth.com/rd/.