Back to resultsUsing Virtual Reality for Patients With Gastrointestinal Disease
Primary Purpose
Gastrointestinal Disease, Inflammatory Bowel Diseases
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HealthVoyager
Standard Practice
Sponsored by
About this trial
This is an interventional health services research trial for Gastrointestinal Disease focused on measuring Crohns disease, Patient Education, Ulcerative Colitis, Celiac, Ulcer, Polyp, Gastrointestinal bleeding, Inflammatory Bowel Disease, Virtual Reality
Eligibility Criteria
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
Sites / Locations
- Boston Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard Practice
Virtual Reality
Arm Description
Patients and families will be shown images of their endoscopic procedure per standard practice.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Longitudinal Medication Adherence
Medication Adherence will be assessed via retrospective chart review and medication refill data.
Longitudinal Readmission Rate
Readmission rates will be measured via retrospective chart review and hospital admission data.
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.
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.
Full Information
NCT ID
NCT03719209
First Posted
October 7, 2018
Last Updated
May 7, 2019
Sponsor
Boston Children's Hospital
Collaborators
Klick Health
1. Study Identification
Unique Protocol Identification Number
NCT03719209
Brief Title
Using Virtual Reality for Patients With Gastrointestinal Disease
Official Title
Using Virtual Reality to Foster Engagement, Understanding, and Knowledge in Patients With Gastrointestinal Disease and Their Families
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Klick Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disease, Inflammatory Bowel Diseases
Keywords
Crohns disease, Patient Education, Ulcerative Colitis, Celiac, Ulcer, Polyp, Gastrointestinal bleeding, Inflammatory Bowel Disease, Virtual Reality
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Practice
Arm Type
Placebo Comparator
Arm Description
Patients and families will be shown images of their endoscopic procedure per standard practice.
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HealthVoyager
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Practice
Intervention Description
Patients and families will receive handouts with printed images of their endoscopic findings, as per standard practice at Boston Children's Hospital.
Primary Outcome Measure Information:
Title
Patient and family knowledge, understanding, and satisfaction
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Longitudinal Medication Adherence
Description
Medication Adherence will be assessed via retrospective chart review and medication refill data.
Time Frame
up to 5 years
Title
Longitudinal Readmission Rate
Description
Readmission rates will be measured via retrospective chart review and hospital admission data.
Time Frame
up to 5 years
Title
Patient Satisfaction Scale
Description
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.
Time Frame
1 month
Title
Client Satisfaction Questionnaire
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
McKenzie Leier, BA
Phone
6179194609
Email
mckenzie.leier@childrens.harvard.edu
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
McKenzie M Leier, BA
Phone
617-919-4609
Email
mckenzie.leier@childrens.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31789778
Citation
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.
Results Reference
derived
Learn more about this trial
Using Virtual Reality for Patients With Gastrointestinal Disease
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