An interventional study of Mobile-Compatible Web-Based Hydration Tracking Program in Dehydration, Older Adults (65 Years and Older) and Hydration Status, sponsored by Ezgi Atasoy. Not yet recruiting. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by Ezgi Atasoy · Not applicable, Interventional, and Health services research
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.
1.1 Definition and Importance of the Problem Maintaining adequate fluid intake is a critical component of health across all stages of life. Proper hydration is essential for regulating blood pressure, enabling biochemical reactions, supporting nutrient digestion and absorption, maintaining cell and tissue function, thermoregulation, joint lubrication, and the elimination of toxins from the body (Armstrong \& Johnson, 2018; Lorenzo et al., 2019; Li et al., 2023).
In older adults, various physiological and behavioral changes make it difficult to maintain adequate hydration. These include a diminished sense of thirst, reduced total body water, forgetfulness, aversion to the taste of water, fear of incontinence, and difficulty accessing fluids due to mobility issues. Such factors often lead to insufficient hydration and, eventually, to dehydration (Masot et al., 2020; Mentes \& Gaspar, 2020; Dmitrieva et al., 2024).
Dehydration is a common condition among the older adults, particularly in institutional settings, and is associated with numerous negative health outcomes. These include headaches, dizziness, urinary tract infections, constipation, medication toxicity, respiratory infections, reduced muscle strength, delayed wound healing, fatigue, increased risk of falls, and cognitive impairment (Paulis et al., 2022; Parkinson et al., 2023; Purvis \& Gion, 2024). In addition to increasing morbidity and mortality, dehydration extends hospital stays and increases readmission rates (Edmonds et al., 2021; Beck et al., 2021).
In Türkiye, studies indicate that approximately one in three individuals over the age of 65 attending outpatient clinics show signs of dehydration. Factors such as female gender, low education level, diabetes mellitus, and chronic kidney disease have been found to be associated with higher dehydration risk. Dehydrated individuals are also more likely to experience reduced physical functioning, sarcopenia, and falls (Atcıyurt et al., 2023).
While dehydration is often preventable, older adults may face challenges in recognizing or responding to their hydration needs. However, consistent daily fluid intake and regular monitoring can significantly reduce the risk. Hence, effective hydration self-management strategies are crucial for maintaining health and preventing complications among older adults (Jimoh et al., 2015; Garcia, 2022; Syed et al., 2024).
Recent interventions based on self-monitoring and digital support, such as wearable devices and mobile apps, have shown promising results. While there are some Turkish studies evaluating the effectiveness of education and auditory reminders (e.g., smartwatches) in nursing home residents (Çetin \& Eşer, 2022), there is a lack of randomized trials focused on mobile health apps specifically tailored for older adult users in Türkiye.
Mobile health (mHealth) applications can support older adults by helping them monitor their fluid intake independently and consistently. Compared to smartwatches, mobile apps offer broader interactivity, greater visual clarity, and more accessible learning tools including videos, infographics, and personalized feedback (Siette et al., 2020). Apps also provide reminders and motivational tools that can promote sustained behavioral change.
In this context, the mobile-compatible, web-based hydration tracking application "SIVI" was developed to help older adults monitor their fluid intake, learn about hydration, and receive personalized feedback. Designed using principles of gerotechnology and age-friendly usability, SIVI features large fonts, high-contrast colors, customizable daily fluid targets, visual feedback tools, educational videos, and a question-and-answer interface with the researcher.
SIVI's usability and design were informed by prior literature, expert input, and pilot testing with older adults. The program aims to empower older adults to take a more active role in managing their hydration, thereby improving health outcomes and quality of life.
1.2 Aim of the Study This study aims to examine the effect of a mobile-compatible, web-based hydration tracking program developed for older adults on their hydration knowledge, attitudes, behaviors, and daily fluid intake.
1.3 Research Question and Hypotheses Research Question: Does the use of the mobile-compatible, web-based hydration tracking application (SIVI) improve daily fluid intake and hydration-related knowledge, attitudes, and behaviors among older adults? Null Hypothesis (H0): There is no statistically significant difference between the intervention and control groups in hydration knowledge, attitude, behavior, and fluid intake scores after the intervention.
Alternative Hypotheses:
H4: There will be a statistically significant increase in daily fluid intake in the intervention group compared to the control group.
2. MATERIALS AND METHODS 2.1 Study Design This study is designed as a single-blind, block-randomized controlled trial. The aim is to assess the impact of the SIVI mobile-compatible web-based hydration tracking program on hydration knowledge, attitudes, behaviors, and fluid intake among community-dwelling older adults. The study will be conducted between October 2025 and March 2026 at Mehmet Fevzi Özsaruhan No. 24 Family Health Center in İzmir, Türkiye. Participants will be randomly assigned to either the intervention or control group in equal numbers using block randomization. To prevent bias, the statistician conducting data analysis will be blinded to group allocation.
2.2 Population and Sampling The study population will include individuals aged 65 to 84 years who live in the community and meet the inclusion criteria. A power analysis indicated that a sample of 26 individuals per group (total n=52) would provide 80% power to detect a moderate effect size. To account for potential dropouts, the sample size was increased to 35 participants per group (total n=70).
Inclusion Criteria:
Exclusion Criteria:
The following validated and researcher-developed instruments will be used for data collection:
The intervention group will receive face-to-face training and install the SIVI app, which they will use for eight weeks. Features of the app include:
The control group will receive only routine care services. They will not use the app.
2.5 Data Collection Procedure
Data will be collected at three points:
Post-test (2 Months): Final data collection, including SUS for the intervention group Daily app usage is expected to take less than five minutes. 2.6 Data Analysis Statistical analysis will be performed using SPSS version 22.0. The Shapiro-Wilk test will assess normality. Depending on distribution characteristics, Student's t-tests or Mann-Whitney U tests will be used for between-group comparisons. Repeated measures ANOVA or Friedman tests will analyze within-group changes over time. Chi-square tests will be applied for categorical variables. Significance will be set at p\<0.05.
3. ETHICAL CONSIDERATIONS AND LIMITATIONS 3.1 Ethical Considerations This study was approved by the Non-Interventional Research Ethics Committee. All procedures will be conducted in accordance with the Declaration of Helsinki and relevant national regulations. Written informed consent will be obtained from all participants prior to inclusion in the study.
Participation in the study is entirely voluntary, and participants are free to withdraw at any time without any consequences. Confidentiality and anonymity of the data will be strictly maintained. The application's backend will store data on encrypted servers compliant with Personal Data Protection Law.
The study does not involve any invasive procedures, and there are no known significant physical risks associated with participation. Participants can mute reminders or exit the app at any time.
A family physician on the research team will monitor participants for adverse events such as vomiting, fever, or upper respiratory tract infections. If any clinical condition arises that could affect hydration needs, the physician will advise whether the participant should pause app use.
3.2 Limitations Several limitations must be acknowledged in interpreting the study findings. First, the study is single-center and conducted only in İzmir, Türkiye, which may limit the generalizability of results to other regions or populations. Second, the sample is restricted to individuals who own smartphones and are digitally literate. Third, the follow-up period is limited to two months, and long-term effects of the intervention will not be evaluated.
Additionally, standardized bottles and visual diary features in the intervention group aim to minimize measurement variability. Lastly, outcome assessors and the data analyst will remain blinded to reduce risk of bias.
4. CONTRIBUTIONS 4. Scientific and Practical Contributions
This study is expected to make several contributions to the field of geriatric health and mobile health (mHealth) interventions:
5. CONCLUSION This study addresses an urgent and under-recognized public health issue-dehydration among older adults-through the development and testing of a mobile-compatible, web-based hydration tracking application named SIVI. Given the high prevalence of dehydration in this population and its association with multiple adverse health outcomes, innovative solutions that promote hydration self-management are needed. The SIVI application, designed with age-appropriate features and content, represents a practical, scalable, and evidence-informed approach to digital health promotion By combining behavioral theory, gerontological principles, and user-centered technology design, the intervention aims to foster meaningful changes in hydration knowledge, attitudes, and daily habits. If successful, the program will support community-dwelling older adults in meeting their daily fluid intake needs, potentially preventing complications and enhancing overall well-being.
The study's design-a single-blind, block-randomized controlled trial-ensures methodological rigor and enhances the validity of its findings. The use of validated measurement tools, real-time tracking, and usability assessments strengthens the study's reliability. Moreover, ethical principles and participant safety are prioritized throughout the intervention period, supported by routine health monitoring by a qualified physician The findings from this research are expected to make a significant contribution to the fields of geriatric nursing, health informatics, and public health. The results could inform future interventions, contribute to policy development on older care and digital inclusion, and inspire further innovation in mobile health tools designed for vulnerable populations Ultimately, this study demonstrates how digital tools, when thoughtfully designed and evidence-based-can empower older adults to take control of their health in simple but impactful ways.
6.REFERANCES
(2020). Fluid Intake Recommendation Considering the Physiological Adaptations of Adults Over 65 Years: A Critical Review. Nutrients, 12(11), 3383. https://doi.org/10.3390/nu12113383 12. Mentes, J. C., \& Gaspar, P. M. (2020). Hydration Management. Journal of gerontological nursing, 46(2), 19-30. https://doi.org/10.3928/00989134-20200108-03 13. Parkinson, E., Hooper, L., Fynn, J., Wilsher, S. H., Oladosu, T., Poland, F., Roberts, S., Van Hout, E., \& Bunn, D. (2023). Low-intake dehydration prevalence in non-hospitalised older adults: Systematic review and meta-analysis. Clinical nutrition (Edinburgh,Scotland),42(8),1510-1520. https://doi.org/10.1016/j.clnu.2023.06.010 14. Paulis, S. J. C., Everink, I. H. J., Halfens, R. J. G., Lohrmann, C., \& Schols, J. M. G. A. (2022). Dehydration in the nursing home: Recognition and interventions taken by Dutch nursing staff. Journal of advanced nursing, 78(4), 1044-1054. https://doi.org/10.1111/jan.15032 15. Purvis, S., \& Gion, T. (2024). Fluid Status Vulnerability in Older Adults. Journal of infusion nursing: the official publication of the Infusion Nurses Society, 47(1), 49-53. https://doi.org/10.1097/NAN.0000000000000534 16. Siette, J., Berry, H., Jorgensen, M., Brett, L., Georgiou, A., McClean, T., … \& Westbrook, J. (2020). Social participation among older adults receiving community care services. Journal of Applied Gerontology, 40(9), 997-1007. https://doi.org/10.1177/0733464820938973 17. Syed, S, Devlin, K, Andrade, A, Flanagan, K, Bruyn-Martin, L, Millar, V, Brown, S and Keller, H. (2024). Wet Your Whistle with Water (W3) to Improve Water Intake in Seniors' Care. Journal of Long-Term Care, , pp. 107-121. https://doi. org/10.31389/jltc.219 18. Veilleux, J. C., Caldwell, A. R., Johnson, E. C., Kavouras, S., McDermott, B. P., \& Ganio, M. S. (2020). Examining the links between hydration knowledge, attitudes and behavior. European journal of nutrition, 59, 991-1000.
19. Volkert, D., Beck, A. M., Cederholm, T., Cruz-Jentoft, A., Goisser, S., Hooper, L., Kiesswetter, E., Maggio, M., Raynaud-Simon, A., Sieber, C. C., Sobotka, L., van Asselt, D., Wirth, R., \& Bischoff, S. C. (2019). ESPEN guideline on clinical nutrition and hydration in geriatrics. Clinical nutrition (Edinburgh, Scotland), 38(1), 10-47. https://doi.org/10.1016/j.clnu.2018.05.024 20. Volkert D, Marie Beck A, Cederholm T, Cruz-Jentoft A, Hooper L, Kiesswetter E, Maggio M, Sieber C, Sobotka L, van Asselt D, Wirth R, Bischoff SC, Benoit F, De Breucker S, Raynaud-Simon A, Annweiler C, Sanchez-Rodriguez D. (2024). Guide pratique de la Société européenne de nutrition clinique : nutrition clinique et hydratation en gériatrie. Geriatr Psychol Neuropsychiatr Vieil; 22(3): 273-315. doi:10.1684/pnv.2024.1183
201 studies on the registry are indexed under Dehydration; 28 are open to participants now.
This study's planned enrollment of 70 is above the median of 43 across 145 interventional studies indexed under Dehydration.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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.
Time frame: Baseline and 8 weeks after the intervention
System Usability Score of the Mobile Hydration Tracking Application
Usability and user satisfaction with the hydration tracking mobile application will be assessed using the Turkish version of the System Usability Scale (SUS). The SUS consists of 10 items rated on a 5-point Likert scale. The total score is calculated by summing item scores after reverse scoring specific items (2, 4, 6, 8, and 10), then multiplying the result by 2.5 to yield a total score ranging from 0 to 100. Higher scores indicate better usability. Scores of 65-70 and above reflect acceptable usability. The SUS is a reliable, validated tool to assess user experience in mobile health interventions
Time frame: Week 4 and Week 8 after intervention
Fluid Intake Habits Based on Self-Reported Form
Fluid intake habits will be assessed using a self-developed "Fluid Intake Habits Form" created by the investigator. The form collects descriptive data on the types and amounts of fluids consumed daily, frequency and timing of fluid intake, personal fluid intake goals, and behaviors such as self-monitoring. The form also identifies factors affecting fluid consumption (e.g., medication use, chronic illness, environmental influences). Expert opinion will obtained to validate the content. Responses will be analyzed to observe qualitative and quantitative changes in fluid intake patterns over the course of the intervention.
Time frame: Baseline, Week 4, and Week 8
No study locations are listed for this record.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, 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.
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