Gastrointestinal DiseaseNCT03719209
Using Virtual Reality for Patients With Gastrointestinal Disease
A study testing HealthVoyager and Standard Practice in people with Gastrointestinal Disease and Inflammatory Bowel Diseases, run by Boston Children's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Gastrointestinal Disease, Inflammatory Bowel Diseases
- What is being tested?
- HealthVoyager and Standard Practice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients who are unable to provide consent due to age or developmental status
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
McKenzie M Leier, BA, 617-919-4609, mckenzie.leier@childrens.harvard.edu
About this study
Official title: 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.
- Being tested
- HealthVoyager, Standard Practice
- Keywords
- Crohns disease, Patient Education, Ulcerative Colitis, Celiac, Ulcer, Polyp, Gastrointestinal bleeding, Inflammatory Bowel Disease, Virtual Reality
- Medical subject headings
- Gastrointestinal Diseases, Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Celiac Disease, Ulcer, Polyps, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthVoyagerOther
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 PracticeOther
Patients and families will receive handouts with printed images of their endoscopic findings, as per standard practice at Boston Children's Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Standard Practice | Placebo comparator | Patients and families will be shown images of their endoscopic procedure per standard practice. Receives: 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. Receives: Other: HealthVoyager |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (4)
Longitudinal Medication Adherence
Medication Adherence will be assessed via retrospective chart review and medication refill data.
Measured: up to 5 years
Longitudinal Readmission Rate
Readmission rates will be measured via retrospective chart review and hospital admission data.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Sep 2017
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Klick Health
- Responsible party
- Principal investigator, Michael Docktor, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719209
- Sponsor's protocol ID
- P00024632
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2018
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31789778
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality to Foster Engagement, Understanding, and Knowledge in Patients With Gastrointestinal Disease and Their Families
- ClinicalTrials.gov ID
- NCT03719209
- Acronym / sponsor ID
- P00024632
- Keywords
- Crohns disease, Patient Education, Ulcerative Colitis, Celiac, Ulcer, Polyp, Gastrointestinal bleeding, Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Klick Health
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Practice | Placebo comparator | Other: Standard PracticePatients and families will be shown images of their endoscopic procedure per standard practice. |
| Virtual Reality | Experimental | Other: HealthVoyagerPatients and families will be showed the results of their endoscopic procedure via a virtual reality application called HealthVoyager, in addition to standard practice images. |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who are unable to provide consent due to age or developmental status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthVoyagerHealthVoyager 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. | Other | Virtual Reality |
| Standard PracticePatients and families will receive handouts with printed images of their endoscopic findings, as per standard practice at Boston Children's Hospital. | Other | Standard Practice |
Primary outcome
Patient and family knowledge, understanding, and satisfaction
Time frame: 1 month
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.
4 secondary outcomes
Longitudinal Medication Adherence
Time frame: up to 5 years
Longitudinal Readmission Rate
Time frame: up to 5 years
Patient Satisfaction Scale
Time frame: 1 month
Client Satisfaction Questionnaire
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Derived from this study: PubMed 31789778Palanica 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthVoyager and Standard Practice in people with Gastrointestinal Disease and Inflammatory Bowel Diseases, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact McKenzie Leier, BA (6179194609, mckenzie.leier@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and family knowledge, understanding, and satisfaction (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03719209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.