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Completed

NCT Number: NCT03787615

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sipIT tools

Device

Just in time drinking detection tools to promote increase fluid consumption

Primary outcomes

  1. 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

Secondary outcomes

  1. Difficulty of Use Subscale of the User Burden Scale

    Time frame: 3 months

    Difficulty of Use subscale of the User Burden Scale (Suh et al., 2016).

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: sipIT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2018
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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