Using Virtual Reality for Patients With Gastrointestinal Disease

NCT03719209 | Unknown

• 1 other identifier: P00024632
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Disease; Inflammatory Bowel Diseases

Keywords

Crohns disease; Patient Education; Ulcerative Colitis; Celiac; Ulcer; Polyp; Gastrointestinal bleeding; Inflammatory Bowel Disease; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Longitudinal Medication Adherence

  up to 5 years

• Longitudinal Readmission Rate

  up to 5 years

• Patient Satisfaction Scale

  1 month

• Client Satisfaction Questionnaire

  1 month

Study Arms (2)

Standard Practice

PLACEBO COMPARATOR

Patients and families will be shown images of their endoscopic procedure per standard practice.

Other: Standard Practice

Virtual Reality

EXPERIMENTAL

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

Interventions

HealthVoyager OTHER

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.

Virtual Reality

Standard Practice OTHER

Patients and families will receive handouts with printed images of their endoscopic findings, as per standard practice at Boston Children's Hospital.

Standard Practice

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Klick Health: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 31789778 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Celiac Disease; Ulcer; Polyps; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Digestive System Diseases; Gastroenteritis; Intestinal Diseases; Colitis; Colonic Diseases; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Hemorrhage

Central Study Contacts

McKenzie Leier, BA

CONTACT

6179194609; mckenzie.leier@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Division of Gastroenterology, Hepatology, and Nutrition

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 25, 2018
• Study Start: September 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 9, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)