Viewing Study NCT05192928



Ignite Creation Date: 2024-05-06 @ 5:07 PM
Last Modification Date: 2024-10-26 @ 2:22 PM
Study NCT ID: NCT05192928
Status: COMPLETED
Last Update Posted: 2022-01-14
First Post: 2021-12-17

Brief Title: Feasibility of Ripple Health Smart Pill Caps in Clinical Settings
Sponsor: Manan Shukla
Organization: Ripple Health

Study Overview

Official Title: Understanding the Feasibility of Ripple Health Smart Pill Caps in Clinical Settings and the Devices Effects on Medical Interventions
Status: COMPLETED
Status Verified Date: 2022-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this research is to determine whether Ripple Health Smart Medicine Bottle Caps can allow for better interface medication administration than traditional pill bottles A secondary goal of the study is to determine whether the smart medication caps can allow the physician to intervene in the patients health regimen when necessary This occurs when the patient does not take medication for reasons such as the painful side effects of the medication or the high cost of the medication itself By intervening a physician can therefore help increase patient adherence and improve transparency between the patient and the physician

The bottle cap is in essence a pill bottle that contains circuitry in the cap of the bottle which sends data to a physician over a wifi network Once the patient opens the pill bottle sensors inside the bottle cap will trigger and send data to the web server indicating that the patient has taken the medicationwe are assuming that the patient takes the medication if heshe opens the pill bottle The server will then add this data into a database that is available to the physician to view In this study the proposed use of this pill bottle is as a simple medication container that gets opened when the patient needs to take hisher medication
Detailed Description: Approximately 133 million or six out of ten patients are affected by at least one chronic disease such as heart disease stroke or diabetes National Health Council Although these diseases can be treated easily using medications millions of adults die inside the hospital room due to chronic complications This is due to a problem known as Medical Non-adherence in which millions of patients do not take their medication as prescribed by the physician This inhibits the physicians ability to properly treat their patients leading to a poor patient outcome Such an issue has affected almost every aspect of healthcare from avoidable hospitalization to insurance wastes At the same time clinical trial results also tend to be skewed because the variable of adherence is not controlled

The Ripple Health patented smart pill dispenser was therefore created as one of the first objective healthcare technologies that can send real-time patient adherence information to the physician and pharmacist through an IoT Cloud system Not only can the device provide useful insights to pharmacies physicians and the patients loved ones but it can also save billions of dollars lost by insurance companies hospitals and the Center of Medicare Services by reducing avoidable hospitalizations and allowing the patient to remain on their treatment regimen Finally by implementing such a technology in clinical experiments the probability of skewed results will decrease as medical adherence in a clinical field will be more controlled

At the same time the Ripple Health dispenser is also affordable with a cost of approximately three dollars mass-produced By becoming extremely cost effective not only will most patients be able to afford it but this device will be widely available to patients around the country at a negligible price

The purpose of this research is to determine whether Ripple Health Smart Medicine Bottle Caps can allow for better interface medication administration than traditional pill bottles A secondary goal of the study is to determine whether the smart medication caps can allow the physician to intervene in the patients health regimen when necessary This occurs when the patient does not take medication for reasons such as the painful side effects of the medication or the high cost of the medication itself By intervening a physician can therefore help increase patient adherence and improve transparency between the patient and the physician

The bottle cap is in essence a pill bottle that contains circuitry in the cap of the bottle which sends data to a physician over a wifi network Once the patient opens the pill bottle sensors inside the bottle cap will trigger and send data to the web server indicating that the patient has taken the medicationwe are assuming that the patient takes the medication if heshe opens the pill bottle The server will then add this data into a database that is available to the physician to view In this study the proposed use of this pill bottle is as a simple medication container that gets opened when the patient needs to take hisher medication

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: True
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None