Using Virtual Reality for Patients With Gastrointestinal Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03719209
• Other study ID #: P00024632
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: October 2019

Study information

• Verified date: October 2018
• Source: Boston Children’s Hospital
• Contact: McKenzie Leier, BA
• Phone: 6179194609
• Email: mckenzie.leier[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Klick Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Longitudinal Medication Adherence	Medication Adherence will be assessed via retrospective chart review and medication refill data.	up to 5 years
Secondary	Longitudinal Readmission Rate	Readmission rates will be measured via retrospective chart review and hospital admission data.	up to 5 years
Secondary	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
Secondary	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