Chronic DiseaseNCT05192928
Feasibility of Ripple Health Smart Pill Caps in Clinical Settings
A study testing Ripple Health Smart Pill Cap in people with Chronic Disease and Asthma, run by Manan Shukla at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Asthma
- What is being tested?
- Ripple Health Smart Pill Cap
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2020to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients in the clinic above the age of 18 with the ability to consent and have a prescribed medication from the clinic will be asked to participate in the study. All patients also must be proficient in English.
- Patients who are minors are required do have at least 1 capable guardian/parent who will be administering the medication and using the pill bottle.
- This will be determined by the physician, as he has seen such a patient in the past. The physician will determine whether the patient has a physical or mental condition and thus will be excluded from the study.
- The parent of the minor must also be mentally and physically capable of opening the pill bottle.
- Patients are also required to have wifi-connectivity in order to consent.
Who cannot join
- All subjects in the study must be above the age of 18- whether they are the patients themselves, or the parents of the patients. All age related criteria about the patient can be determined from an EHR service that is already being used in the clinic
- Patients who cannot use the bottle due to a physical(cannot open the bottle) or mental condition will not be allowed to participate in the study. This will be determined by the physician, as he has seen such a patient in the past. The physician will determine whether the patient has a physical or mental condition and thus will be excluded from the study.
- Patients above 18 who are unable to consent will be excluded from the study. The ability to consent will be determined through the physician, who will decide whether the patient is able to consent to the study. The physician, who has worked with the patient significantly in the past, will be able to determine whether the patient is able to consent to the study.
- Minors whose guardian/parent is unable to consent will be excluded from the study. This will be determined by the physician, as he has seen such a patient in the past. The physician will determine whether the patient has a physical or mental condition and thus will be excluded from the study. The parents of the minors must also be able to physically open the pill bottle.
- Minors who are mentally and physically incapable will be excluded from the study. This will be determined by the physician, as he has seen such a patient in the past. The physician will determine whether the patient has a physical or mental condition and thus will be excluded from the study.
- Patients without wifi connectivity will be excluded from the study. We can determine patients who have wifi-connectivity by asking the patient if he/she has connectivity in his/her residence. Patients who have limited English proficiency will be excluded from the study. This can be determined through conversation with the patient. If the patient shows signs of a limited English proficiency, the patient will be excluded from the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Allergy Asthma Sleep Center
Astoria, New York, 11103
Allergy Asthma Sleep Center
Brooklyn, New York, 11235
Allergy Asthma Sleep Center
New York, New York, 10016
Allergy Asthma Sleep Center
Staten Island, New York, 10305
About this study
Official title: Understanding the Feasibility of Ripple Health Smart Pill Caps in Clinical Settings, and the Devices' Effects on Medical Interventions.
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 patient's 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 medication(we are assuming that the patient takes the medication if he/she 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 his/her medication.
Read the 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 physician's 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 patient's 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 patient's 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 medication(we are assuming that the patient takes the medication if he/she 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 his/her medication.
- Conditions
- Chronic Disease, Asthma
- Being tested
- Ripple Health Smart Pill Cap
- Keywords
- Compliance, Interventions, Feasibility
- Medical subject headings
- Chronic Disease, Asthma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ripple Health Smart Pill CapDevice
Also called Ripple Health Smart Pill Bottle
The device is a smart medical device created to allow physicians to have better access to patient compliance data, and intervene on the patient's health through the use of a text message, phone call, or email.
| Study group | Role | What they receive |
|---|---|---|
| All Patients using the Ripple Health Smart Pill Cap | Experimental | In this single-arm trial, all patients will be using the Ripple Health Smart Pill Cap as a method of medication administration Receives: Device: Ripple Health Smart Pill Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of provider interventions done per patient
Measures the total amount of provider interventions when the patient was non-compliant.
Measured: 1 month
Total number of malfunctions present throughout the trial
Measures the total amount of malfunctions each device had throughout the trial.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Jul 2020
- Primary completion1 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manan Shukla
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Manan Shukla, Ripple Health
- Investigators
- Manan Shukla, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192928
- Sponsor's protocol ID
- 1280044
- Status last verified
- Jan 2022
- First submitted
- 17 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Feasibility of Ripple Health Smart Pill Caps in Clinical Settings, and the Devices' Effects on Medical Interventions.
- ClinicalTrials.gov ID
- NCT05192928
- Acronym / sponsor ID
- 1280044
- Conditions
- Chronic Disease, Asthma
- Keywords
- Compliance, Interventions, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Manan ShuklaIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient's 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 medication(we are assuming that the patient takes the medication if he/she 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 his/her 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 physician's 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 patient's 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 patient's 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 medication(we are assuming that the patient takes the medication if he/she 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 his/her medication.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients using the Ripple Health Smart Pill Cap | Experimental | Device: Ripple Health Smart Pill CapIn this single-arm trial, all patients will be using the Ripple Health Smart Pill Cap as a method of medication administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients in the clinic above the age of 18 with the ability to consent and have a prescribed medication from the clinic will be asked to participate in the study. All patients also must be proficient in English.
- Patients who are minors are required do have at least 1 capable guardian/parent who will be administering the medication and using the pill bottle.
- This will be determined by the physician, as he has seen such a patient in the past. The physician will determine whether the patient has a physical or mental condition and thus will be excluded from the study.
- The parent of the minor must also be mentally and physically capable of opening the pill bottle.
- Patients are also required to have wifi-connectivity in order to consent.
Key exclusion criteria (6 listed)
- All subjects in the study must be above the age of 18- whether they are the patients themselves, or the parents of the patients. All age related criteria about the patient can be determined from an EHR service that is already being used in the clinic
- Patients who cannot use the bottle due to a physical(cannot open the bottle) or mental condition will not be allowed to participate in the study. This will be determined by the physician, as he has seen such a patient in the past. The physician will determine whether the patient has a physical or mental condition and thus will be excluded from the study.
- Patients above 18 who are unable to consent will be excluded from the study. The ability to consent will be determined through the physician, who will decide whether the patient is able to consent to the study. The physician, who has worked with the patient significantly in the past, will be able to determine whether the patient is able to consent to the study.
- Minors whose guardian/parent is unable to consent will be excluded from the study. This will be determined by the physician, as he has seen such a patient in the past. The physician will determine whether the patient has a physical or mental condition and thus will be excluded from the study. The parents of the minors must also be able to physically open the pill bottle.
- Minors who are mentally and physically incapable will be excluded from the study. This will be determined by the physician, as he has seen such a patient in the past. The physician will determine whether the patient has a physical or mental condition and thus will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ripple Health Smart Pill CapAlso: Ripple Health Smart Pill BottleThe device is a smart medical device created to allow physicians to have better access to patient compliance data, and intervene on the patient's health through the use of a text message, phone call, or email. | Device | All Patients using the Ripple Health Smart Pill Cap |
Primary outcome
Amount of provider interventions done per patient
Time frame: 1 month
Measures the total amount of provider interventions when the patient was non-compliant.
Total number of malfunctions present throughout the trial
Time frame: 1 month
Measures the total amount of malfunctions each device had throughout the trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manan Shukla principal investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ripple Health Smart Pill Cap in people with Chronic Disease and Asthma, run by Manan Shukla at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of provider interventions done per patient (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.