Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03787615
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
David E Conroy, Penn State University

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.

Condition or disease Intervention/treatment Phase
Urolithiasis Device: sipIT tools Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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)
Primary Purpose: Prevention
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
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: David E Conroy, PhD. 814-863-3451 dec9@psu.edu
Contact: Deborah L Brunke-Reese, BS 814-865-7935 dlb43@psu.edu

Locations
Layout table for location information
United States, Pennsylvania
The Pennsylvania State University Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Joshua A Cermak, MS    814-865-7935    jac1468@psu.edu   
Contact: Ashley B Sanders, MS    814-865-7935    abs63@psu.edu   
Sponsors and Collaborators
Penn State University
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: David E Conroy, PhD The Pennsylvania State University
  Study Documents (Full-Text)

Documents provided by David E Conroy, Penn State University:
Informed Consent Form  [PDF] November 12, 2018


Layout table for additonal information
Responsible Party: David E Conroy, Professor of Kinesiology and Human Development & Family Studies, Penn State University
ClinicalTrials.gov Identifier: NCT03787615     History of Changes
Other Study ID Numbers: STUDY00010778
UL1TR002014 ( U.S. NIH Grant/Contract )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share the individual participant data with other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by David E Conroy, Penn State University:
kidney

Additional relevant MeSH terms:
Layout table for MeSH terms
Urolithiasis
Urologic Diseases