Using Virtual Reality for Patients With Gastrointestinal Disease

Using Virtual Reality to Foster Engagement, Understanding, and Knowledge in Patients With Gastrointestinal Disease and Their Families

The primary aim of this study is to evaluate the effect and impact of a technology which creates a virtual reality (VR), personalized representation of a patient's endoscopic findings in comparison our standard practice (SP). Our study will compare the level of knowledge, understanding and satisfaction the patient and family have between those receiving SP and those receiving both SP and VR.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases; Gastrointestinal Disease
• Intervention / Treatment: Other: Standard Practice; Other: HealthVoyager

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: McKenzie M Leier, BA; Phone Number: 617-919-4609; Email: mckenzie.leier@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 8-25 years of age who are willing and able to participate
• Patients who recently had an endoscopic procedure at Boston Children's Hospital

Exclusion Criteria:

• Patients who are unable to provide consent due to age or developmental status

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard Practice; Patients and families will be shown images of their endoscopic procedure per standard practice.	Other: Standard Practice; Patients and families will receive handouts with printed images of their endoscopic findings, as per standard practice at Boston Children's Hospital.
Experimental: Virtual Reality; Patients and families will be showed the results of their endoscopic procedure via a virtual reality application called HealthVoyager, in addition to standard practice images.	Other: HealthVoyager; HealthVoyager is a virtual reality application that allows providers to create customized representations for patients and share the results of endoscopic procedures via an interactive platform. The app can show both normal and abnormal endoscopic findings and anatomy. Families will also receive a web link so that they may access the procedure results via the app at home on their smartphone or tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and family knowledge, understanding, and satisfaction	Our study will measure the levels of patient and family engagement using a survey designed specifically for the study. The survey is at a roughly 3rd grade reading level and includes approximately 10 questions with answers on a Likert scale. The internally designed survey will specifically measure patient and family opinions on learning about the results of their procedure, as well as objective anatomical knowledge. The minimum score for each question is a 1, designating "Strongly disagree." The maximum score for each question is a 10, designating "Strongly agree." Thus, higher scores represent better outcomes.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal Medication Adherence	Medication Adherence will be assessed via retrospective chart review and medication refill data.	up to 5 years
Longitudinal Readmission Rate	Readmission rates will be measured via retrospective chart review and hospital admission data.	up to 5 years
Patient Satisfaction Scale	The Patient Satisfaction Scale (Hojat et al., 2011) will be used to measure patient satisfaction. The Patient Satisfaction Scale is a validated survey with 10 questions. Respondents can answer 1 through 7 for each question. 1 represents "Strongly Disagree" while 7 represents "Strongly Agree." Higher score represent better outcomes in this scale.	1 month
Client Satisfaction Questionnaire	The Client Satisfaction Questionnaire (Larsen et al., 1979) will measure client satisfaction. The questionnaire has 8 questions with 4 possible answers for each question. A 4 represents the best possible outcome; a 1 represents the worst possible outcome.	1 month

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Klick Health

Publications and helpful links

General Publications

• Palanica A, Leier M, Lee A, Fossat Y, Docktor MJ. Enhancing the Patient Experience for Individuals Undergoing Endoscopic Procedures Using Virtual Reality. J Pediatr Gastroenterol Nutr. 2020 Mar;70(3):341-343. doi: 10.1097/MPG.0000000000002577.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 7, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; Virtual Reality; Patient Education; Ulcer; Crohns disease; Celiac; Polyp; Gastrointestinal bleeding
• Additional Relevant MeSH Terms: Gastroenteritis; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases
• Other Study ID Numbers: P00024632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No