Clinical trial NCT05509738: Feasibility of Text4US Program
Official title: Feasibility of A Text Message-Based Healthcare Assistant in Pediatric Lower Urinary Tract Symptoms Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Reminder Systems
Text Messaging
Urinary Dysfunction
Urinary Bladder
Behavior Change Techniques
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned into two groups that differ only in the order of receiving the text message-based healthcare assistance as an adjunct to their children's standard care.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Parents/guardians 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 child's 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 child's 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 child's basic information (e.g., 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 children's daily goal achievement Monday to Friday evenings. Timely feedback (e.g., 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 (e.g., research iPad) provided by the research team member (e.g., 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 (e.g., 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.

Eligibility criteria: Inclusion Criteria:

* Parents/guardians (above the age of 18) of children (5-18 years old) who have completed potty training with pLUTS.
* Parents/patients that have never completed a bladder/food diary before
* Fluent in English
* Able to receive text messages on a mobile device
* Referred with a diagnosis of LUTS in our outpatient clinic

Exclusion Criteria:

1. Parents/guardians of children with

   1. neurogenic bladder
   2. Genitourinary (GU) abnormalities
   3. Detrusor sphincter dyssynergia (DSD)
   4. renal transplant patients (pre and post)
   5. abdominal or spinal surgeries within one year
   6. other chronic illness that is known to affect LUTS
   7. currently on immunosuppression of any kind
   8. younger than 5 years old or older than 18 years old
2. Younger than 18 years old
3. Not fluent in English
4. Not able to receive text messages
5. filled out a bladder and/or food diary before

Primary outcomes:
measure: Feasibility of Text-Messaging System
timeFrame: 3 years
measure: Usefulness and Acceptability of the Text4US program
timeFrame: 3 years
measure: Effectiveness of the Text4US program
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Kathleen Kan, MD
role: PRINCIPAL_INVESTIGATOR
References: