NCT07043933

Brief Summary

This randomized controlled trial aims to evaluate the impact of a mobile-friendly, web-based hydration tracking application (named "SIVI") on hydration-related knowledge, attitudes, and behaviors in older adults. Inadequate fluid intake is a common and modifiable risk factor for dehydration in the elderly, leading to increased morbidity, hospitalizations, and functional decline. However, many older individuals forget to drink fluids or face barriers such as fear of incontinence, mobility limitations, or cognitive challenges. This study will include 70 community-dwelling older adults aged 65-84 years, recruited from a Family Health Center. Participants will be randomly assigned to either the intervention or control group. The intervention group will use the SIVI application for two months. The app is specially designed for older adults and includes features such as personalized fluid goals, reminders, hydration education modules, feedback, and a user-friendly interface with large fonts and high contrast. Participants will log their daily fluid intake, receive motivational messages, and access videos and information about healthy hydration habits. A water bottle will be provided to standardize measurement across groups. The control group will receive only routine care. Both groups will complete questionnaires measuring demographics, hydration knowledge, attitudes, behaviors, and fluid consumption habits at baseline, one month, and two months. Data collection will be conducted face-to-face by the researcher, and analysis will be performed using SPSS 22.0. Statistical tests will include descriptive statistics, Shapiro-Wilk for normality, chi-square for categorical data, and t-tests and ANOVA for comparisons over time. The results are expected to show that the SIVI application improves older adults' hydration knowledge, fosters positive attitudes, and promotes healthy fluid intake behaviors, thus supporting self-management of hydration and potentially reducing dehydration-related health risks.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 21, 2025

Last Update Submit

June 21, 2025

Conditions

Keywords

DehydrationAgedHydrationOlder AdultsMobile ApplicationsSelf-Management

Outcome Measures

Primary Outcomes (1)

  • Hydration Knowledge, Attitude, and Behavior Scale Scores

    Participants' hydration-related knowledge, attitude, and behavior will be assessed using the Turkish version of the Hydration Knowledge, Attitude, and Behavior Scale (HyKS). The scale includes 16 knowledge items, 18 attitude items, and 4 behavior items. Scores are calculated separately for each domain. Higher scores indicate improved knowledge, more positive attitudes, and healthier hydration behaviors.

    Baseline and 8 weeks after the intervention

Secondary Outcomes (1)

  • System Usability Score of the Mobile Hydration Tracking Application

    Week 4 and Week 8 after intervention

Other Outcomes (1)

  • Fluid Intake Habits Based on Self-Reported Form

    Baseline, Week 4, and Week 8

Study Arms (2)

Arm 1: Intervention Group

EXPERIMENTAL

Participants in this group will receive individualized face-to-face training and use the mobile-compatible, web-based hydration tracking application (SIVI) daily for 8 weeks. They will receive reminders, set personalized fluid intake goals, track their daily intake using visual tools, and access educational materials through the app. A standard water bottle will also be provided for consistent measurement.

Behavioral: Mobile-Compatible Web-Based Hydration Tracking Program

Arm 2: Control Group

NO INTERVENTION

Participants in this group will receive rutine care. They will not receive access to the SIVI application or any structured follow-up. A standard water bottle will also be provided for intake tracking purposes.

Interventions

Intervention Description: The SIVI Hydration Application is a mobile-compatible, web-based behavioral intervention designed specifically for older adults. It supports self-monitoring and self-management of daily fluid intake through features such as personalized fluid goals, visual drink-logging with icons, daily reminders, progress graphics, educational videos, and motivational digital badges. The app was developed using gerotechnology and universal design principles to accommodate cognitive and sensory changes common in aging. Its unique focus on hydration behavior, combined with usability features like large fonts, high contrast, and voice-assisted guidance, distinguishes it from general health or diet tracking apps. Participants use the app for 8 weeks as part of a structured intervention with training and weekly follow-up.

Also known as: SIVI Mobile Hydration Tracker, SIVI Hydration Application
Arm 1: Intervention Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Daily water and other fluid intake below the recommended levels: less than 2.0 L/day for older adult men and less than 1.6 L/day for older adult women (ESPEN Guidelines, 2024) Aged between 65 and 84 years Having at least a primary school education Having sufficient motor skills Having the cognitive capacity, willingness, and experience necessary to use technology Willing to participate in the study Owning a mobile phone compatible with the application Having prior experience using mobile applications

You may not qualify if:

  • Diagnosed with moderate or severe cognitive impairment (MMSE \< 24)
  • Having vision or hearing impairments that prevent participation
  • Diagnosed with advanced stage chronic kidney disease (Stage 4-5)
  • Diagnosed with congestive heart failure (NYHA class III-IV)
  • Being on fluid restriction by medical order
  • Having a diagnosed urinary incontinence condition
  • Having a diagnosis of terminal illness or active cancer treatment
  • Participating in another hydration-related clinical study
  • Experiencing a disruption in app usage for one week or longer for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Özlem KÜÇÜKGÜÇLÜ, Prof.

    Dokuz Eylul University Faculty of Nursing

    STUDY DIRECTOR

Central Study Contacts

Ezgi ATASOY ATASOY, MSc, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Only the outcomes assessor (data analyst/statistician) is blinded to the allocation of participants to reduce the risk of bias.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the intervention group, which receives the mobile-compatible web-based hydration application, or the control group, which receives standard education. Each group will be followed in parallel for 8 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer (Part-Time)

Study Record Dates

First Submitted

June 21, 2025

First Posted

June 29, 2025

Study Start

October 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) including scores from the Hydration Knowledge, Attitude, and Behavior Scale (HyKS), System Usability Scale (SUS), and self-reported fluid intake data will be shared with qualified researchers upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
The IPD and supporting documentation will be available starting 6 months after publication of the main study results. Data will be accessible for a period of 5 years from that date.
Access Criteria
Access will be granted to qualified researchers affiliated with academic institutions or healthcare organizations, for the purpose of conducting meta-analyses or secondary analyses related to hydration behavior in older adults. Requests can be made by contacting the principal investigator via email. A data access agreement may be required.