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

NCT03787615 | Completed Results FDA Device

• 2 other identifiers: STUDY00010778UL1TR002014
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis

Keywords

kidney

Outcome Measures

Primary Outcomes (1)

• Adherence to Intervention Assessed by Study Completion

  Participants who continue to use the sipIT tools (app, connected water bottle, and smartwatch) at 3 month follow-up

  3 months

Secondary Outcomes (1)

• Difficulty of Use Subscale of the User Burden Scale

  3 months

Study Arms (1)

The sipIT tools

OTHER

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

Interventions

sipIT tools DEVICE

Just in time drinking detection tools to promote increase fluid consumption

The sipIT tools

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any medical condition that interferes with regular fluid consumption

Sponsors & Collaborators

• Penn State University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

• 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.

  PMID: 33252930 DERIVED

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. David Conroy
• Organization: The Pennsylvania State University

conroy@psu.edu

814-863-3451

Study Officials

• David E Conroy, PhD

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology and Human Development & Family Studies

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 26, 2018
• Study Start: November 19, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 17, 2021
• Results First Posted: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)