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Urinary Tract StoneStoneAppNCT05627622

Effectiveness of WhatsApp Education and Support Messages for Urolithiasis Prevention

A study testing WhatsApp health education message in people with Urinary Tract Stone, run by Rabin Medical Center at 1 site in Israel.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Kidney and ureteral stones are a common problem in primary care practice with increasing prevalence over the last few decades. Prevention of recurrent stones (which are usually composed primarily of calcium oxalate) is aimed at decreasing the concentrations of the lithogenic factors. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Urinary Tract Stone
What is being tested?
WhatsApp health education message
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteIsrael
Study dates
1 Jan 2021to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Capacity to give informed consent
  • Personal history of urolithiasis
  • Stone free status
  • A personal mobile phone with WhatsApp Messenger® application

Who cannot join

  • Children
  • Does not read Hebrew, the language in which the messages are written

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Rabin Medical Center

    Petah Tikva, 49414

Other trials in Israel

About this study

Kidney and ureteral stones are a common problem in primary care practice with increasing prevalence over the last few decades.

Prevention of recurrent stones (which are usually composed primarily of calcium oxalate) is aimed at decreasing the concentrations of the lithogenic factors. There are several metabolic and dietary treatable components. In all patients with urolithiasis, adequate fluid intake and lower body mass index are key components to reducing the risk of recurrent stones. For most patients, additional beneficial dietary modifications are increasing intake of fruits and vegetables which are rich in potassium, and reducing intake of candies and sweetened juices which are rich in sucrose and fructose. In addition, for patients who have been prescribed medications, adherence to medication may become an important issue over the long term.

Read more

Mobile technology has the potential to optimize health care and patient's adherence, especially through personal education and dissemination of health information. One of the most common technologies available on mobile is the WhatsApp Messenger® application. WhatsApp is a freeware messaging service; it allows streamlining patient-provider communication via text and voice messages, video clips and images.

The research hypotheses are, first, that use of WhatsApp to disseminate information regarding stones preventive measures will have a substantial positive effect on follow-up compliance and on patient's adherence to the preventive measures. Second, the investigators expect reduction in cumulative stone recurrence rate.

Read the detailed description

Kidney and ureteral stones are a common problem in primary care practice with increasing prevalence over the last few decades. Nineteen percent of men and nine percent of women will be diagnosed with a kidney stone by the age of 70 years,and the rates of emergency department visit for urolithiasis were increased from 178 to 340 visits per 100,000 individuals from 1992 to 2009 (United States).

Prevention of recurrent stones, which are usually composed primarily of calcium oxalate, is aimed at decreasing the concentrations of the lithogenic factors. There are several metabolic and dietary treatable components. In all patients with urolithiasis, adequate fluid intake and lower body mass index are key components to reducing the risk of recurrent stones. For most patients, additional beneficial dietary modifications are increasing intake of fruits and vegetables which are rich in potassium, and reducing intake of candies and sweetened juices which are rich in sucrose and fructose. In addition, for patients who have been prescribed medications, adherence to medication may become an important issue over the long term.

As early as the 1980s, "The stone clinic effect" on the recurrence rate of stone disease was published. Hosking et al. demonstrated that a regimen of increased fluid intake and appropriate dietary modifications, to avoid dietary excesses, reduces stone growth and new stone formation in patients with idiopathic calcium urolithiasis.

According to the 2019 European Association of Urology guidelines on urolithiasis, all stone formers, independent of their individual risk, should follow preventive measures such as circadian fluid drinking of 2.5-3 liter daily, limitation of NaCl content to 5 gram daily.

The trials documenting benefit from these preventive measures required at least three years before the results were significant. However, in an analysis of over 3000 patients followed in a well-organized stone clinic at the University of Chicago, between 20% and 30% of patients were lost to follow-up every year. Only 15 to 40 percent of patients complied with the follow-up requirements by three years. Adherence to long-term therapy among those who did not follow-up was presumably very low. Hence, improving patient's adherence and follow-up compliance is of paramount importance.

Mobile technology has the potential to optimize health care and patient's adherence, especially through personal education and dissemination of health information. One of the most common technologies available on mobile is the WhatsApp Messenger® application. WhatsApp is a freeware messaging service; it allows streamlining patient-provider communication via text and voice messages, video clips and images.

The research hypotheses are, first, that use of WhatsApp to disseminate information regarding stones preventive measures will have a substantial positive effect on follow-up compliance and on patient's adherence to the preventive measures. Second, the investigators expect reduction in cumulative stone recurrence rate.

Methods Hypotheses will be tested in a randomized control trial. Participants will be recruited at the stone clinic of Rabin Medical Center, an academic tertiary hospital. Participants will randomly assign to one of two groups: A, the experimental group, receiving stone-prevention information on a monthly basis, and B, the control group.

Statistical Analysis Based on recurrence rates of previous studies the required number of patients was calculated in expectation of 20% and 40% cumulative recurrence rate of renal stones at 5 years in the experimental and control group, respectively. Type 1 error was set to 5%, and type 2 error was set to 20%. With this assumption, each group has to include 81 patients. Risk and rate ratio of stone recurrence and 95% confidence intervals (CIs) will be calculated. Loss of patients from follow-up will be measured by proportion of patients lost at each year.

Being tested
WhatsApp health education message
Keywords
Urinary Tract Stone, Kidney Stone, Health Education, Preventive Medicine
Medical subject headings
Urinary Calculi, Kidney Calculi, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WhatsApp health education messageBehavioural

    stone-prevention information on a monthly basis, using personal WhatsApp messages

Study groups in NCT05627622
Study groupRoleWhat they receive
Experimental group,ExperimentalReceiving stone-prevention information on a monthly basis, using WhatsApp Messenger® application.
Receives: Behavioral: WhatsApp health education message
control groupNo interventionwill not receive stone-prevention information

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stone recurrence

    Rate of participants with urinary stone recurrence

    Measured: 5 years

Secondary outcomes (2)
  1. Mean time to relapse

    Mean time to urinary stone event

    Measured: 5 years

  2. Lost to follow-up rate

    Rate of participants lost to follow-up in the urinary stone clinic

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2022
  2. Study start1 Jan 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized control trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05627622
Sponsor's protocol ID
StoneApp
Acronym
StoneApp
Status last verified
Jul 2025
First submitted
16 Nov 2022
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hosking DH, Erickson SB, Van den Berg CJ, Wilson DM, Smith LH. The stone clinic effect in patients with idiopathic calcium urolithiasis. J Urol. 1983 Dec;130(6):1115-8. doi: 10.1016/s0022-5347(17)51711-5.

    PubMed 6644890
  • Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk C. Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol. 2015 Apr;67(4):750-63. doi: 10.1016/j.eururo.2014.10.029. Epub 2014 Nov 20.

    PubMed 25454613
  • Ackermann D. Prophylaxis in idiopathic calcium urolithiasis. Urol Res. 1990;18 Suppl 1:S37-40. doi: 10.1007/BF00301526.

    PubMed 2291248
  • Sromicki J, Hess B. Simple dietary advice targeting five urinary parameters reduces urinary supersaturation in idiopathic calcium oxalate stone formers. Urolithiasis. 2020 Oct;48(5):425-433. doi: 10.1007/s00240-020-01194-7. Epub 2020 Jun 10.

    PubMed 32524204

Questions about this trial

What is this clinical trial studying?

A study testing WhatsApp health education message in people with Urinary Tract Stone, run by Rabin Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stone recurrence (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05627622, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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