Feasibility of Text4US Program

NCT05509738 | Terminated

• 1 other identifier: 65815
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Reminder Systems; Text Messaging; Urinary Dysfunction; Urinary Bladder; Behavior Change Techniques

Outcome Measures

Primary Outcomes (3)

• Feasibility of Text-Messaging System

  The feasibility of the Text4US program as assessed by: 1. study recruitment and retention rates 2. time required to recruit target participants 3. cost associated with developing the Text4US program and maintaining the program until the completion of data collection 4. participants' mobile/cell phone usage and preferred healthcare tools (assessed in pre-survey) 5. differences in completion rates between bladder and food diaries (control condition) and reflection surveys (intervention condition).

  3 years

• Usefulness and Acceptability of the Text4US program

  The usefulness and acceptability of the Text4US program as assessed by post-surveys adapted from Agyapong et al. (2013) with questions focusing on participants' engagement, satisfaction, experience, and intention to use. The responses differences between post-surveys of bladder and food diaries (control condition) and the Text4US program (intervention condition) will be examined. Besides, open-ended questions in post-surveys asking for participants' suggestions about the Text4US program will also be qualitatively analyzed.

  3 years

• Effectiveness of the Text4US program

  The effectiveness of the Text4US program as assessed by: 1. participants' self-efficacy: one 5-point Likert Scale question focusing on participants' self-efficacy in healthy bladder behavior adoption, changes from baseline to the end of bladder \& food diaries phase (control condition), and the end of the Text4US phase (intervention condition) 2. participants' perceived effects: differences in participants' perceived effects of bladder and food diaries (control condition) and the Test4US program (intervention condition) on bladder health. Assessment questions are adapted from Agyapong et al. (2013) and presented in post-surveys. 3. children's healthy bladder behavior: differences in participant's self-reported healthy bladder behavior between bladder and food diaries (control condition) and reflection surveys (intervention condition).

  3 years

Study Arms (2)

Group 1: Diaries - SMS

EXPERIMENTAL

Group 1 will be asked to complete a 2-day bladder diary + food diary during the first two weeks of the study, then will receive SMS Text reminders during the last 2 weeks of the study. Both groups will complete a pre-survey at the beginning of the study and a post-survey after each phase of the study (total 2 post-surveys).

Behavioral: SMS Text Messaging

Group 2: SMS - Diaries

EXPERIMENTAL

Group 2 will receive SMS Text reminders during the first 2 weeks of the study, and then will be asked to complete a 2-day bladder diary + food diary during the last two weeks of the study. Both groups will complete a pre-survey at the beginning of the study and a post-survey after each phase of the study (total 2 post-surveys).

Behavioral: SMS Text Messaging

Interventions

SMS Text Messaging BEHAVIORAL

The text message-based healthcare assistance includes 1) message reminders and 2) a daily achievement reflection. 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.

Group 1: Diaries - SMS; Group 2: SMS - Diaries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Palo Alto, California, 94304, United States

Location

Study Officials

• Kathleen Kan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CLINICAL ASSISTANT PROFESSOR, UROLOGY

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 22, 2022
• Study Start: November 17, 2022
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)