Feasibility of Using sipIT Tools to Increase Compliance With Fluid Consumption Guidelines in Urolithiasis-Prone Subjects (sipIT)
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|ClinicalTrials.gov Identifier: NCT03787615|
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : January 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urolithiasis||Device: sipIT tools||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Feasibility of Using sipIT Tools to Increase Compliance With Fluid Consumption Guidelines in Urolithiasis -Prone Subjects|
|Actual Study Start Date :||November 19, 2018|
|Actual Primary Completion Date :||December 1, 2019|
|Actual Study Completion Date :||December 1, 2019|
The sipIT tools
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.
Device: sipIT tools
Just in time drinking detection tools to promote increase fluid consumption
- 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
- Difficulty of Use assessed by participant self-report [ Time Frame: 3 months ]Difficulty of Use subscale of the User Burden Scale (Suh et al., 2016)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787615
|United States, Pennsylvania|
|The Pennsylvania State University|
|University Park, Pennsylvania, United States, 16802|
|Principal Investigator:||David E Conroy, PhD||The Pennsylvania State University|