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

NCT ID: NCT03787615

Last Updated: 2021-03-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2019-12-01

Brief Summary

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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

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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

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Urolithiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

sipIT tools

Intervention Type DEVICE

Just in time drinking detection tools to promote increase fluid consumption

Interventions

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sipIT tools

Just in time drinking detection tools to promote increase fluid consumption

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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David E Conroy

Professor of Kinesiology and Human Development & Family Studies

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David E Conroy, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

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The Pennsylvania State University

University Park, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33252930 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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UL1TR002014

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00010778

Identifier Type: -

Identifier Source: org_study_id

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