Using Virtual Reality for Patients With Gastrointestinal Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastrointestinal Disease, Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: HealthVoyager
* Other: Standard Practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Practice<br>Patients and families will be shown images of their endoscopic procedure per standard practice. | Other: Standard Practice<br>* Patients and families will receive handouts with printed images of their endoscopic findings, as per standard practice at Boston Children's Hospital.<br>|
| Experimental: Virtual Reality<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohns disease, Patient Education, Ulcerative Colitis, Celiac, Ulcer, Polyp, Gastrointestinal bleeding, Inflammatory Bowel Disease, Virtual Reality