Trial Outcomes & Findings for Feasibility of Using sipIT Tools to Increase Compliance With Fluid Consumption Guidelines in Urolithiasis-Prone Subjects (NCT NCT03787615)

NCT ID: NCT03787615

Last Updated: 2021-03-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-03-17

Participant Flow

Participant milestones

Measure	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. sipIT tools: Just in time drinking detection tools to promote increase fluid consumption
Overall Study STARTED	31
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	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. sipIT tools: Just in time drinking detection tools to promote increase fluid consumption
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	The sipIT Tools n=31 Participants 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. sipIT tools: Just in time drinking detection tools to promote increase fluid consumption
Age, Continuous	40.0 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	The sipIT Tools n=31 Participants 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. sipIT tools: Just in time drinking detection tools to promote increase fluid consumption
Adherence to Intervention Assessed by Study Completion	27 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Completers at 3-months only

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

Outcome measures

Measure	The sipIT Tools n=27 Participants 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. sipIT tools: Just in time drinking detection tools to promote increase fluid consumption
Difficulty of Use Subscale of the User Burden Scale	NA score on a scale Standard Deviation NA In analyses, we found that six items had no variance and all items had mean values \<1. Because of these skewed distributions and the restricted range indicative of little to no user burden, most sub-scale internal consistency estimates were not acceptable so scores from this measure were not calculated.

Adverse Events

The sipIT Tools

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Conroy

The Pennsylvania State University

Phone: 814-863-3451

Email: conroy@psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place