Evaluating Mobile Health Tool Use for Capturing Patient-centered Outcomes Measures in HF Patients
-
- STATUS
- Recruiting
-
- days left to enroll
- 30
-
- participants needed
- 150
-
- sponsor
- Biofourmis Singapore Pte Ltd.
Summary
The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Patients with HF have reduced function capacity and quality of life (QoL) and hence it is imperative to explore interventions that impact endpoints that directly measure how a patient feels or functions on a daily basis.
Recently, new mobile health technologies have emerged as clinical tools and offer an opportunity to overcome these challenges in measuring functional capacity and recording symptoms. These technologies are able to capture and integrate data from disparate sources from individual patients reflecting their functional status and symptomatology. These data can potentially serve as surrogate endpoints for approval of new HF therapies.
In this study, the investigators will test the feasibility of a novel mobile health monitoring platform to capture patients' physiology, functional capacity and assessment of quality of life.
Description
Heart Failure (HF) is a highly prevalent disease that also carries high morbidity and mortality. Improvements in mortality and healthcare utilization, including hospitalizations of HF still remain the gold standard outcomes for HF drug approval. However, it is difficult to improve mortality as the only endpoint due to the variation in the age groups and comorbidities of the population and ineffectiveness to alter all-cause mortality, particularly in patients with heart failure with preserved ejection fraction (HFpEF). Considering these issues, there is a need for exploration of complimentary endpoints. The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Patients with HF have reduced function capacity and quality of life (QoL) and hence it is imperative to explore interventions that impact endpoints that directly measure how a patient feels or functions on a daily basis. Although functional status can be objectively measured by peak exercise oxygen consumption, it is difficult and impractical to implement in large clinical studies, especially in an ambulatory real-world setting. Other objective measures of functional status include a 6-minute walk test (6MWT) and potentially measures of activity using implanted or wearable sensors. Patient-reported outcomes (PROMs) can also be used to record and quantify symptoms but are cumbersome and impractical since significant resources are required to contact patients and administer questionnaires. It is also particularly difficult to record these and correlate with physiologic signals in real-time.
Recently, new mobile health technologies have emerged as clinical tools and offer an opportunity to overcome these challenges in measuring functional capacity and recording symptoms. These technologies are able to capture and integrate data from disparate sources from individual patients reflecting their functional status and symptomatology. These data can potentially serve as surrogate endpoints for approval of new HF therapies. A novel mobile health platform (BiovitalsHF, developed by Biofourmis) enables continuous acquisition and monitoring of multiple physiologic data (for e.g. electrocardiogram, heart rate, respiration rate, activity intensity, 3-axis accelerometer and sleep) using readily available biosensors (Everion® MD and Apple Watch will be used for this study). The BiovitalsHF smartphone app is capable of capturing patient's physiology, functional capacity (using activity patterns, including guided mobile-based 6MWT) and assessment of QoL through validated PROs.
Details
| Condition | Heart Failure |
|---|---|
| Clinical Study Identifier | NCT04191356 |
| Sponsor | Biofourmis Singapore Pte Ltd. |
| Last Modified on | 4 June 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer