Arterial HypertensionNCT05735808
VR Education in Arterial Hypertension
A study testing Physician based education and VR based education in people with Arterial Hypertension, run by Poliklinika Agel, Dopravni zdravotnictvi a.s. at 1 site in Czechia.
Trial summary
The aim of this study is to compare standard education with VR augmented education in patients with arterial hypertension Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- Physician based education and VR based education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Jul 2023to 30 Jun 2024
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all consecutive patients with arterial hypertension
Who cannot join
- visual impairment
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Poliklinika Agel
Ostrava
Bogna Jiravska Godula, MD, +420724307894, bogna.jiravska-godula@npo.agel.cz
Otakar Jiravský, MD, +420602579193, otakar.jiravsky@npo.agel.cz
About this study
Official title: A Pilot Study of the Feasibility and Non-inferiority of Patient Education About Arterial Hypertension in Virtual Reality
The aim of this study is to compare standard education with VR augmented education in patients with arterial hypertension
Read the detailed description
To demonstrate the technical and organizational feasibility of patient education about arterial hypertension in virtual reality. Demonstrate the non-inferiority of education conducted in virtual reality to traditional face-to-face education by a physician. To define the cost-effectiveness of education in virtual reality in the reality of progressing shortage of human resources.
Patients diagnosed with arterial hypertension as part of a routine examination in an internal medicine outpatient clinic will be randomized to education about the disease directly by a physician in one arm or using a 3D movie in VR glasses filmed by a physician in an identical outpatient clinic setting. It will be concluded by questionnaire method to compare the outcome of both education namely subjective satisfaction and objectively by using questions to evaluate the success of the education.
- Conditions
- Arterial Hypertension
- Being tested
- Physician based education, VR based education
- Keywords
- virtual reality education
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician based educationBehavioural
Regular education provided by physician
VR based educationBehavioural
VR based education
| Study group | Role | What they receive |
|---|---|---|
| Standart physicain based education | Active comparator | In this arm, patient education will be conducted by the physician as the gold standard. Receives: Behavioral: Physician based education |
| VR based education | Experimental | In this arm, patient education will be performed using 3D educational material presented in VR glasses. Receives: Behavioral: VR based education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Inferiority of VR augmented education: physician assessment of objective patient understanding
After the education, the patient will answer a prepared list of questions on arterial hypertension whose answers were mentioned in the previous education and the percentage of correct/wrong answers will be compared in both arms of the study.
Measured: 18 months
Non-Inferiority of VR augmented education:subjective evaluation of education by the patient
After the education, the patient will rate how he/she subjectively perceived the subjective pleasantness of the education on a scale of 1 to 5 ( 1 best/ 5 worst).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start7 Jul 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poliklinika Agel, Dopravni zdravotnictvi a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bogna Jiravska Godula, Poliklinika Agel, Dopravni zdravotnictvi a.s.
- Investigators
- Otakar Jiravsky, Study chair, Nemocnice AGEL Trinec-Podlesi a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735808
- Sponsor's protocol ID
- PAgel
- Status last verified
- Jul 2023
- First submitted
- 12 Jan 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only basic demographic data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Feasibility and Non-inferiority of Patient Education About Arterial Hypertension in Virtual Reality
- ClinicalTrials.gov ID
- NCT05735808
- Acronym / sponsor ID
- PAgel
- Conditions
- Arterial Hypertension
- Keywords
- virtual reality education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poliklinika Agel, Dopravni zdravotnictvi a.s.University, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 21 Feb 2023 (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 aim of this study is to compare standard education with VR augmented education in patients with arterial hypertension
Detailed description
To demonstrate the technical and organizational feasibility of patient education about arterial hypertension in virtual reality. Demonstrate the non-inferiority of education conducted in virtual reality to traditional face-to-face education by a physician. To define the cost-effectiveness of education in virtual reality in the reality of progressing shortage of human resources.
Patients diagnosed with arterial hypertension as part of a routine examination in an internal medicine outpatient clinic will be randomized to education about the disease directly by a physician in one arm or using a 3D movie in VR glasses filmed by a physician in an identical outpatient clinic setting. It will be concluded by questionnaire method to compare the outcome of both education namely subjective satisfaction and objectively by using questions to evaluate the success of the education.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standart physicain based education | Active comparator | Behavioral: Physician based educationIn this arm, patient education will be conducted by the physician as the gold standard. |
| VR based education | Experimental | Behavioral: VR based educationIn this arm, patient education will be performed using 3D educational material presented in VR glasses. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive patients with arterial hypertension
Key exclusion criteria (1 listed)
- visual impairment
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 |
|---|---|---|
| Physician based educationRegular education provided by physician | Behavioural | Standart physicain based education |
| VR based educationVR based education | Behavioural | VR based education |
Primary outcome
Non-Inferiority of VR augmented education: physician assessment of objective patient understanding
Time frame: 18 months
After the education, the patient will answer a prepared list of questions on arterial hypertension whose answers were mentioned in the previous education and the percentage of correct/wrong answers will be compared in both arms of the study.
Non-Inferiority of VR augmented education:subjective evaluation of education by the patient
Time frame: 18 months
After the education, the patient will rate how he/she subjectively perceived the subjective pleasantness of the education on a scale of 1 to 5 ( 1 best/ 5 worst).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No. Only basic demographic data will be shared
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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.
Otakar Jiravsky study chair
Nemocnice AGEL Trinec-Podlesi a.s.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician based education and VR based education in people with Arterial Hypertension, run by Poliklinika Agel, Dopravni zdravotnictvi a.s. at 1 site in Czechia.
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 1 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 10 Jul 2023. 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 Czechia. 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. 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 Bogna Jiravska Godula, MD (+420602579193, Bogna.jiravska-godula@npo.agel.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Inferiority of VR augmented education: physician assessment of objective patient understanding (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2023.