Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05509738
Status:
TERMINATED
Last Update Posted:
2024-02-28
First Post:
2022-08-16
Brief Title:
Feasibility of Text4US Program
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Feasibility of A Text Message-Based Healthcare Assistant in Pediatric Lower Urinary Tract Symptoms Care
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Text4US
Brief Summary:
Pediatric Lower Urinary Tract Symptoms pLUTS is common in school-age children and can negatively impact the quality of their life Although at least 50 of children with pLUTS can improve through behavioral changes how to support parents in helping their children adopt healthy bladder behaviors remains unrevealed To solve this problem the investigators developed an early model of a text message-based healthcare assistant The aim of this study is to examine the feasibility of the text message-based healthcare assistant in pLUTS care
Detailed Description:
In this study an early model of a text message-based healthcare assistant will be configured The service provided by the proposed healthcare assistant includes 1 daily message reminders and 2 daily achievement reflection By employing the text message-based healthcare assistant in pLUTS care the investigators hope to learn
1 If the text message-based healthcare assistant could support parents of children with pLUTS in helping their children adopt healthy bladder behaviors
2 What is parents experience with the text message-based healthcare assistant in pLUTS care
3 How to improve the text-message-based healthcare assistant in the future
To date these questions have not been answered in the existing literature on digital health The study findings will deepen the understanding of treatment options for pLUTS and provide an opportunity to optimize pediatric urology practice by integrating digital technology
The study aims to evaluate the feasibility of using a text message-based healthcare assistant to support parents of children with LUTS in helping their children adopt healthy bladder behaviors Therefore the involvement of human subjects is necessary
Parentsguardians of children 5-18 years old who present to the pediatric urology outpatient clinic for the first visit for pLUTS or attend a clinic program called Bladder Bootcamp a one-hour Zoom urotherapy education session in a non-medical group setting will be identified Clinic staff or Bladder Bootcamp instructors will introduce the research staff to potential participants during the waiting time A research team member will neutrally invite potential participants to participate in the study by briefly describing it For those who are not interested the research team member will thank them for their time and not proceed forward For those who are interested the research team member will provide them with further study details screen their eligibility and review the consent form with those who are eligible The consent form will emphasize that
1 participation is voluntary
2 participation will not affect the care under any circumstances
3 participants can end participation at any time
4 research staff will never share participants identities with anyone else confidentiality will be maintained
Upon taking the consent the study will be conducted The total length of the study is four weeks Participants will spend two weeks using a bladder diary and food diary to record their childs behaviors for 2 days a part of standard care They will spend another two weeks receiving personalized healthcare assistance via text messaging as an adjunct to their childs standard care The order of using bladder and food diaries and receiving test messages-based healthcare assistance depends on which group participants were randomly assigned The purpose of randomly assigning participants into two groups is to reduce research biases
Specifically the study has three phases
Phase I At the beginning of the study
Evaluate participants ability to receive text messages
Provide participants with all the materials they need for this study including bladder diary food diary participants instruction and a bladder health education handout
Use an online survey to collect participants and their childs basic information eg demographic data phone usage
Phase II During the 2 weeks of using bladder and food diaries
Ask participants to fill out a bladder diary and food diary for 2 days
Send participants an online survey asking about their experience with the bladder and food diaries
Phase III During the 2 weeks of receiving text messages
Provide participants the text message-based healthcare assistance
Send participants an online survey asking about their experience with the text message-based healthcare assistant
The text message-based healthcare assistance provided in Phase III includes 1 message reminders and 2 a daily achievement reflection The delivery schedule is as below The delivery schedule is as below
1 Message reminders
The investigators will send participants two text reminders per day one in the morning and one in the afternoon from Monday to Friday with the information on helping their child achieve healthy bladder goals
2 Daily achievement reflection
The investigators will send participants a text message with a survey link to reflect their and their childrens daily goal achievement Monday to Friday evenings Timely feedback eg inspirational and compliment messages will be provided based on participants responses
To increase the response rate Phase I will be conducted after taking the consent and in the presence of the research team member For participants recruited in the clinic they will fill out the survey using the university encrypted devices eg research iPad provided by the research team member eg research iPad If participants prefer to fill out the survey using their own devices the research team member will send the survey link to them For participants recruited in Bladder Bootcamp online recruitment they need to fill out the survey using the survey link provided by the research team member
Given that participants may not complete all the surveys or answer all the questions in the survey missing data may exist If participants drop out from the study the investigators will recruit another participant to replace the one who dropped out The data of the person who dropped out will be destroyed
All study-related materials eg surveys text messages bladder and food diaries have been attached to Section 16 of the protocol The investigators may use a shortened version of the text messages for the study If there are any changes to the study-related materials the investigators will revise the IRB and upload the final materials
All text messages including survey links sent via text messages will be encrypted and sent by RedCap by using a third-party web service named Twilio which announces HIPAA eligibility in SMS Participants responses will be directly entered into RedCap and will not be collected and stored in Twilio
1 If the text message-based healthcare assistant could support parents of children with pLUTS in helping their children adopt healthy bladder behaviors
2 What is parents experience with the text message-based healthcare assistant in pLUTS care
3 How to improve the text-message-based healthcare assistant in the future
To date these questions have not been answered in the existing literature on digital health The study findings will deepen the understanding of treatment options for pLUTS and provide an opportunity to optimize pediatric urology practice by integrating digital technology
The study aims to evaluate the feasibility of using a text message-based healthcare assistant to support parents of children with LUTS in helping their children adopt healthy bladder behaviors Therefore the involvement of human subjects is necessary
Parentsguardians of children 5-18 years old who present to the pediatric urology outpatient clinic for the first visit for pLUTS or attend a clinic program called Bladder Bootcamp a one-hour Zoom urotherapy education session in a non-medical group setting will be identified Clinic staff or Bladder Bootcamp instructors will introduce the research staff to potential participants during the waiting time A research team member will neutrally invite potential participants to participate in the study by briefly describing it For those who are not interested the research team member will thank them for their time and not proceed forward For those who are interested the research team member will provide them with further study details screen their eligibility and review the consent form with those who are eligible The consent form will emphasize that
1 participation is voluntary
2 participation will not affect the care under any circumstances
3 participants can end participation at any time
4 research staff will never share participants identities with anyone else confidentiality will be maintained
Upon taking the consent the study will be conducted The total length of the study is four weeks Participants will spend two weeks using a bladder diary and food diary to record their childs behaviors for 2 days a part of standard care They will spend another two weeks receiving personalized healthcare assistance via text messaging as an adjunct to their childs standard care The order of using bladder and food diaries and receiving test messages-based healthcare assistance depends on which group participants were randomly assigned The purpose of randomly assigning participants into two groups is to reduce research biases
Specifically the study has three phases
Phase I At the beginning of the study
Evaluate participants ability to receive text messages
Provide participants with all the materials they need for this study including bladder diary food diary participants instruction and a bladder health education handout
Use an online survey to collect participants and their childs basic information eg demographic data phone usage
Phase II During the 2 weeks of using bladder and food diaries
Ask participants to fill out a bladder diary and food diary for 2 days
Send participants an online survey asking about their experience with the bladder and food diaries
Phase III During the 2 weeks of receiving text messages
Provide participants the text message-based healthcare assistance
Send participants an online survey asking about their experience with the text message-based healthcare assistant
The text message-based healthcare assistance provided in Phase III includes 1 message reminders and 2 a daily achievement reflection The delivery schedule is as below The delivery schedule is as below
1 Message reminders
The investigators will send participants two text reminders per day one in the morning and one in the afternoon from Monday to Friday with the information on helping their child achieve healthy bladder goals
2 Daily achievement reflection
The investigators will send participants a text message with a survey link to reflect their and their childrens daily goal achievement Monday to Friday evenings Timely feedback eg inspirational and compliment messages will be provided based on participants responses
To increase the response rate Phase I will be conducted after taking the consent and in the presence of the research team member For participants recruited in the clinic they will fill out the survey using the university encrypted devices eg research iPad provided by the research team member eg research iPad If participants prefer to fill out the survey using their own devices the research team member will send the survey link to them For participants recruited in Bladder Bootcamp online recruitment they need to fill out the survey using the survey link provided by the research team member
Given that participants may not complete all the surveys or answer all the questions in the survey missing data may exist If participants drop out from the study the investigators will recruit another participant to replace the one who dropped out The data of the person who dropped out will be destroyed
All study-related materials eg surveys text messages bladder and food diaries have been attached to Section 16 of the protocol The investigators may use a shortened version of the text messages for the study If there are any changes to the study-related materials the investigators will revise the IRB and upload the final materials
All text messages including survey links sent via text messages will be encrypted and sent by RedCap by using a third-party web service named Twilio which announces HIPAA eligibility in SMS Participants responses will be directly entered into RedCap and will not be collected and stored in Twilio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None