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Feasibility of Using sipIT Tools to Increase Compliance With Fluid Consumption Guidelines in Urolithiasis-Prone Subjects (sipIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03787615
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
David E Conroy, Penn State University

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE December 26, 2018
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE November 19, 2018
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Using sipIT Tools to Increase Compliance With Fluid Consumption Guidelines in Urolithiasis-Prone Subjects
Official Title  ICMJE Feasibility of Using sipIT Tools to Increase Compliance With Fluid Consumption Guidelines in Urolithiasis -Prone Subjects
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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)
Primary Purpose: Prevention
Condition  ICMJE Urolithiasis
Intervention  ICMJE Device: sipIT tools
Just in time drinking detection tools to promote increase fluid consumption
Study Arms  ICMJE 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.
Intervention: Device: sipIT tools
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2020)
31
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2018)
30
Actual Study Completion Date  ICMJE December 1, 2019
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any medical condition that interferes with regular fluid consumption
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03787615
Other Study ID Numbers  ICMJE STUDY00010778
UL1TR002014 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share the individual participant data with other researchers.
Responsible Party David E Conroy, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: David E Conroy, PhD The Pennsylvania State University
PRS Account Penn State University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP