UrolithiasissipITNCT03787615
Feasibility of Using sipIT Tools to Increase Compliance With Fluid Consumption Guidelines in Urolithiasis-Prone Subjects
A study testing sipIT tools in people with Urolithiasis, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility of using sipIT tools (i.e., wrist-worn sensors, smart water bottles, mobile applications) to increase compliance with physician-recommended fluid consumption guidelines in participants with a history of urolithiasis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis
- What is being tested?
- sipIT tools
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Fluent in spoken and written English, and capable of providing informed consent
- Own an iPhone (version 6 or higher)
- History of urolithiasis
- Willingness to complete all study procedures: completing questionnaires, participating in semi-structured interviews, tracking fluid consumption, wearing a FitBit Versa and receiving notifications on the FitBit and their smartphone for a three-month period
Who cannot join
- Any medical condition that interferes with regular fluid consumption
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Feasibility of Using sipIT Tools to Increase Compliance With Fluid Consumption Guidelines in Urolithiasis -Prone Subjects
The purpose of this study is to examine the feasibility of using sipIT tools (i.e., wrist-worn sensors, smart water bottles, mobile applications) to increase compliance with physician-recommended fluid consumption guidelines in participants with a history of urolithiasis. The study aims to: 1) deliver notifications regarding fluid consumption to the FitBit Versa and the participant's smartphone based on the participant's assessed fluid intake, and 2) determine the acceptability of using the sipIT tools to increase fluid consumption. It is hypothesized that receiving notifications regarding fluid consumption will lead to an increased compliance in attaining fluid consumption guidelines. Further, it is hypothesized that the frequency of notifications will diminish across the study duration.
Read the detailed description
Complying with fluid consumption guidelines provides a variety of health benefits. Patients with a history of urolithiasis are a segment of the population that can benefit from meeting physician-recommended fluid consumption guidelines. Preliminary studies with this population have revealed patient interest in using various technologies (i.e., wrist-worn sensors, smart water bottles, mobile applications) to increase their fluid consumption but the investigators are not aware of any that combine multiple technologies. The investigators' long-term goal is to examine if just-in-time reminder notifications to drink following periods when patients have not been drinking will increase compliance among patients with a history of urolithiasis. To prepare for that study, the investigators seek to evaluate the feasibility and acceptability of the sipIT tools in this study.
This study is part three of a set of studies aimed at determining the feasibility of using technology to increase compliance with fluid consumption guidelines. Preliminary data included 1) a focus group of participants with a history of urolithiasis and 2) a lab study to examine the feasibility of using wrist-worn sensors to detect non-alcoholic drinking events. Data from the focus group revealed that participants are interested in using a variety of technologies (e.g., wrist-worn sensors, smart water bottles, mobile applications) to assist with increasing fluid consumption. Data from the lab study revealed that using wrist-worn inertial sensors to detect drinking events is feasible. Based on data from the lab study, an algorithm was developed to detect these drinking events and has been implemented in a consumer smartwatch consumer smartwatch app for just-in-time drinking detection.
- Conditions
- Urolithiasis
- Being tested
- sipIT tools
- Keywords
- kidney
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sipIT toolsDevice
Just in time drinking detection tools to promote increase fluid consumption
| Study group | Role | What they receive |
|---|---|---|
| The sipIT tools | Other | The wrist-worn sensors used to detect a drinking event (FitBit Versa with custom algorithm), an H2OPal connected water bottle and fluid consumption monitoring mobile applications. Receives: Device: sipIT tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Intervention Assessed by Study Completion
Participants who continue to use the sipIT tools (app, connected water bottle, and smartwatch) at 3 month follow-up
Measured: 3 months
Secondary outcomes (1)
Difficulty of Use Subscale of the User Burden Scale
Difficulty of Use subscale of the User Burden Scale (Suh et al., 2016).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start19 Nov 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A variety of technologies (e.g., wrist-worn sensors, smart water bottles, mobile applications) can be utilized to engage participants over time and support compliance with increasing fluid consumption.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, David E Conroy, Penn State University
- Investigators
- David E Conroy, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787615
- Sponsor's protocol ID
- STUDY00010778
- Other IDs
- UL1TR002014
- Acronym
- sipIT
- Status last verified
- Mar 2021
- First submitted
- 20 Dec 2018
- Last updated
- 17 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share the individual participant data with other researchers.
Publications
Conroy DE, West AB, Brunke-Reese D, Thomaz E, Streeper NM. Just-in-time adaptive intervention to promote fluid consumption in patients with kidney stones. Health Psychol. 2020 Dec;39(12):1062-1069. doi: 10.1037/hea0001032.
PubMed 33252930
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using sipIT Tools to Increase Compliance With Fluid Consumption Guidelines in Urolithiasis -Prone Subjects
- ClinicalTrials.gov ID
- NCT03787615
- Acronym / sponsor ID
- sipIT / STUDY00010778
- Conditions
- Urolithiasis
- Keywords
- kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Posted 17 Mar 2021
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 study is to examine the feasibility of using sipIT tools (i.e., wrist-worn sensors, smart water bottles, mobile applications) to increase compliance with physician-recommended fluid consumption guidelines in participants with a history of urolithiasis. The study aims to: 1) deliver notifications regarding fluid consumption to the FitBit Versa and the participant's smartphone based on the participant's assessed fluid intake, and 2) determine the acceptability of using the sipIT tools to increase fluid consumption. It is hypothesized that receiving notifications regarding fluid consumption will lead to an increased compliance in attaining fluid consumption guidelines. Further, it is hypothesized that the frequency of notifications will diminish across the study duration.
Detailed description
Complying with fluid consumption guidelines provides a variety of health benefits. Patients with a history of urolithiasis are a segment of the population that can benefit from meeting physician-recommended fluid consumption guidelines. Preliminary studies with this population have revealed patient interest in using various technologies (i.e., wrist-worn sensors, smart water bottles, mobile applications) to increase their fluid consumption but the investigators are not aware of any that combine multiple technologies. The investigators' long-term goal is to examine if just-in-time reminder notifications to drink following periods when patients have not been drinking will increase compliance among patients with a history of urolithiasis. To prepare for that study, the investigators seek to evaluate the feasibility and acceptability of the sipIT tools in this study.
This study is part three of a set of studies aimed at determining the feasibility of using technology to increase compliance with fluid consumption guidelines. Preliminary data included 1) a focus group of participants with a history of urolithiasis and 2) a lab study to examine the feasibility of using wrist-worn sensors to detect non-alcoholic drinking events. Data from the focus group revealed that participants are interested in using a variety of technologies (e.g., wrist-worn sensors, smart water bottles, mobile applications) to assist with increasing fluid consumption. Data from the lab study revealed that using wrist-worn inertial sensors to detect drinking events is feasible. Based on data from the lab study, an algorithm was developed to detect these drinking events and has been implemented in a consumer smartwatch consumer smartwatch app for just-in-time drinking detection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A variety of technologies (e.g., wrist-worn sensors, smart water bottles, mobile applications) can be utilized to engage participants over time and support compliance with increasing fluid consumption.
| Arm | Type | Receives |
|---|---|---|
| The sipIT tools | Other | Device: sipIT toolsThe wrist-worn sensors used to detect a drinking event (FitBit Versa with custom algorithm), an H2OPal connected water bottle and fluid consumption monitoring mobile applications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fluent in spoken and written English, and capable of providing informed consent
- Own an iPhone (version 6 or higher)
- History of urolithiasis
- Willingness to complete all study procedures: completing questionnaires, participating in semi-structured interviews, tracking fluid consumption, wearing a FitBit Versa and receiving notifications on the FitBit and their smartphone for a three-month period
Key exclusion criteria (1 listed)
- Any medical condition that interferes with regular fluid consumption
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 |
|---|---|---|
| sipIT toolsJust in time drinking detection tools to promote increase fluid consumption | Device | The sipIT tools |
Primary outcome
Adherence to Intervention Assessed by Study Completion
Time frame: 3 months
Participants who continue to use the sipIT tools (app, connected water bottle, and smartwatch) at 3 month follow-up
1 secondary outcome
Difficulty of Use Subscale of the User Burden Scale
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33252930Conroy DE, West AB, Brunke-Reese D, Thomaz E, Streeper NM. Just-in-time adaptive intervention to promote fluid consumption in patients with kidney stones. Health Psychol. 2020 Dec;39(12):1062-1069. doi: 10.1037/hea0001032.
- Individual participant dataSharing planned: No. There is no plan to share the individual participant data with other researchers.
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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.
David E Conroy, PhD principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sipIT tools in people with Urolithiasis, run by Penn State University at 1 site 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 4 inclusion and 1 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 17 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence to Intervention Assessed by Study Completion (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03787615, which also lists 1 linked publication.
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 17 Mar 2021.