Effectiveness of WhatsApp Education and Support Messages for Urolithiasis Prevention (StoneApp)
Primary Purpose
Urinary Tract Stone
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
WhatsApp health education message
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Stone focused on measuring Urinary Tract Stone, Kidney Stone, Health Education, Preventive Medicine
Eligibility Criteria
Inclusion Criteria: Capacity to give informed consent Personal history of urolithiasis Stone free status A personal mobile phone with WhatsApp Messenger® application Exclusion Criteria: Children Does not read Hebrew, the language in which the messages are written
Sites / Locations
- Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group,
control group
Arm Description
Receiving stone-prevention information on a monthly basis, using WhatsApp Messenger® application.
will not receive stone-prevention information
Outcomes
Primary Outcome Measures
Stone recurrence
Rate of participants with urinary stone recurrence
Secondary Outcome Measures
Mean time to relapse
Mean time to urinary stone event
Lost to follow-up rate
Rate of participants lost to follow-up in the urinary stone clinic
Full Information
NCT ID
NCT05627622
First Posted
November 16, 2022
Last Updated
August 18, 2023
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05627622
Brief Title
Effectiveness of WhatsApp Education and Support Messages for Urolithiasis Prevention
Acronym
StoneApp
Official Title
Effectiveness of WhatsApp Education and Support Messages for Urolithiasis Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Stone
Keywords
Urinary Tract Stone, Kidney Stone, Health Education, Preventive Medicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group,
Arm Type
Experimental
Arm Description
Receiving stone-prevention information on a monthly basis, using WhatsApp Messenger® application.
Arm Title
control group
Arm Type
No Intervention
Arm Description
will not receive stone-prevention information
Intervention Type
Behavioral
Intervention Name(s)
WhatsApp health education message
Intervention Description
stone-prevention information on a monthly basis, using personal WhatsApp messages
Primary Outcome Measure Information:
Title
Stone recurrence
Description
Rate of participants with urinary stone recurrence
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Mean time to relapse
Description
Mean time to urinary stone event
Time Frame
5 years
Title
Lost to follow-up rate
Description
Rate of participants lost to follow-up in the urinary stone clinic
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Capacity to give informed consent
Personal history of urolithiasis
Stone free status
A personal mobile phone with WhatsApp Messenger® application
Exclusion Criteria:
Children
Does not read Hebrew, the language in which the messages are written
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MIchael Frumer, MD
Phone
+972542686959
Email
mic1039@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MIchael Frumer, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49414
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Frumer, MD
Phone
+972542686959
Email
mic1039@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
6644890
Citation
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.
Results Reference
background
PubMed Identifier
25454613
Citation
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.
Results Reference
background
PubMed Identifier
2291248
Citation
Ackermann D. Prophylaxis in idiopathic calcium urolithiasis. Urol Res. 1990;18 Suppl 1:S37-40. doi: 10.1007/BF00301526.
Results Reference
background
PubMed Identifier
32524204
Citation
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.
Results Reference
background
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Effectiveness of WhatsApp Education and Support Messages for Urolithiasis Prevention
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