CanceroVIDNCT06054048
Open Video System in Medicine (oVID)
A study testing Telemedicine in people with Cancer and Chronic Heart Failure, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Currently, there are no telemedical visits between patients and/or their relatives and a palliative physician for the evaluation of symptom and progress monitoring. This is done during visits of the patient by the coordinators and palliative physicians of the palliative network/PKD Münster (PKD = Palliative Care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chronic Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2019to 28 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with indications to receive specialized palliative care for advanced malignant and non-malignant diseases
- Minimum age 18 years
- Signed informed consent
- Inpatient care in a normal ward or the palliative care unit at University Hospital Muenster
- Planned discharge to home environment
- Consent to participate in randomized study
Show all 10Show fewer
- Residence in the area of responsibility of the palliative care network/PKD Münster and consent to the Connection to the palliative care network/PKD Münster
- At least one cell phone (or comparable device with camera and microphone) with wireless network connection or long data evolution (LTE) flat rate
- Basic willingness to use new media
- Disease phase "stable" / "unstable" / "deteriorating" (patients who are in the dying phase are not included in the randomized part of the study, as they will in all likelihood not be discharged home).
Who cannot join
- Pregnant or breastfeeding patients
- minors
- Language difficulties (lack of German language skills), if these cannot be compensated by family members or interpreters can be compensated
- Dependency or employment relationship to the project management or the including physician
- Persons who have been placed in an institution by court or official order
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Video System in Medicine (oVID) - Use Case Palliative Care
Currently, there are no telemedical visits between patients and/or their relatives and a palliative physician for the evaluation of symptom and progress monitoring. This is done during visits of the patient by the coordinators and palliative physicians of the palliative network/PKD Münster (PKD = Palliative Care Consultation Service) and/or the general practitioners. Upon enrollment in the Palliative Network/PKD Münster, patients receive a 24-hour emergency telephone number. This is staffed by a caregiver who coordinates the deployment of other caregivers / palliative care physicians according to the information provided by the patient / family members. If patients are randomized to the "telemedicine" group, they have the option of using ELVI (ELVI = electronic visit) in addition to conventional care, and thus the possibility of televisits with physicians or nurses. In this case, they receive access data for ELVI, i.e., an access code for a virtual waiting room. In addition, patients will be given questionnaires at discharge to be completed on the day of discharge and on days 7, and 14.
The primary objective of this randomized trial is to demonstrate that telemedically managed patients are not relevantly inferior to conventionally managed patients in terms of change in Integrated Palliative care Outcome Scale (IPOS) from the day of discharge (non-inferiority question), although the possibility of televisiting may result in less frequent physician visits to the patient's home.
Read the detailed description
Purpose
The increasing specialization of medicine and the growing shortage of medical professionals, especially in rural areas, call for constant networking of clinical facilities. This networking is driven not least by the medical societies. For example, networks have been established throughout Germany in the care of severely injured patients, in neurology, palliative medicine, intensive care medicine, infectious diseases, cardiology and other specialist disciplines. All of these networks aim to improve the joint care of the respective patients, even across sector boundaries.
Moreover, demographic change has been inexorably causing society to age for years. A steadily growing proportion of the population is at an age when the demand for medical treatment is increasing. At the same time, there is a shortage of qualified medical personnel. By 2030, there will be a shortage of up to 106,000 physicians and 575,000 nurses. A double-digit share of all medical positions will probably not be filled. This development is felt with particular intensity in rural areas. Here, the average age of the population and thus the need for medical services, as well as the shortage of doctors and nurses, are even higher than the national average.
In the course of digitization, a wide range of opportunities are opening up that will enable greater efficiency in the treatment of many patients, especially in rural areas. However, the individual networks use heterogeneous, technical systems and standards to a varying extent for this purpose. While the exchange of image data (e.g., X-ray, CT, and MRI examinations) between individual institutions has already become standard in some regions of Germany (e.g., West German Teleradiology Network), there is no communication system that is accessible everywhere and can be used across disciplines, that can be used by every network, that offers the necessary functions, and that can also be adapted to the needs of the respective network. A connection of many different systems is made difficult by high interface, integration and process costs, and in some cases virtually impossible. A system that enables cross-clinic, interdisciplinary communication is not comprehensively available at the present time.
The question of palliative care is becoming increasingly important both in hospitals and in the outpatient setting. Recent studies have shown that palliative care can not only improve the quality of life, but also significantly improve the outcome of treatment and thus prolong survival. Patients with incurable, advanced diseases die more often in hospital than - as often desired - in the home environment. However, both the shortage of physicians and increasing urbanization make it difficult to realize this area-wide provision of palliative care, especially in rural areas. "Communication and shared decision making" and "trust and confidence in treatment partners" are the most important factors for quality end-of-life care. For patients at the end of life, a visit to a (specialist) physician and the associated transport can be a major, energy-sapping and emotional effort. By bringing together various disciplines in one place, as is the case at University Hospital Muenster, and by using telemedical rounds, it may be possible to protect resources on the patient side as well.
Currently, there are no telemedical visits between patients and/or their relatives and a palliative physician for the evaluation of symptom and progress monitoring. This is done during visits of the patient by the coordinators and palliative physicians of the palliative network/PKD Münster and/or the general practitioners. Upon enrollment in the Palliative Network/PKD Münster, patients receive a 24-hour emergency telephone number. This is staffed by a caregiver who coordinates the deployment of other caregivers / palliative care physicians according to the information provided by the patient / family members. If patients are randomized to the "telemedicine" group, they have the option of using ELVI in addition to conventional care, and thus the possibility of televisits with physicians or nurses. In this case, they receive access data for ELVI, i.e., an access code for a virtual waiting room. In addition, patients will be given questionnaires at discharge to be completed on the day of discharge and on days 7, and 14.
The primary objective of this randomized trial is to demonstrate that telemedically managed patients are not relevantly inferior to conventionally managed patients in terms of change in IPOS from the day of discharge (non-inferiority question), although the possibility of televisiting may result in less frequent physician visits to the patient's home.
- Being tested
- Telemedicine
- Medical subject headings
- Neoplasms, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Web Real-Time Communication (WebRTC), which enables a peer-to-peer connectivity. Communication platform for all TCs was the software "CompuGroup Medical Electronic Visit" (CGM ELVI), which provides end-to-end encrypted video conferencing between physicians and their patients.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Active comparator | Those patients who received specialized outpatient palliative care plus telemedicine. Receives: Other: Telemedicine |
| No telemedicine (Standard of Care) | No intervention | Those patients who received standard specialized outpatient palliative care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Control
Change in the Integrated Palliative Care Outcome Scale (IPOS) over the first seven days after transfer (analyzed for the randomized part of the trial in a non-inferiority analysis). The total scores using IPOS can range between 0 and 68 points. The higher the score, the more severe are the patient's symptoms. IPOS was evaluated using a paper questionnaire. seven days after transfer (analyzed for the randomized part of the trial in a non-inferiority analysis).
Measured: 7 days
Secondary outcomes (5)
Reason for request
What were the reasons for requesting the telemedicine rounds?
Measured: up to two weeks
resulting interventions
What actions resulted from the telemedical consultations (e.g., changes in medications, hospitalizations)?
Measured: up to two weeks
avoidance of home visits
How many specialized outpatient palliative care home visits were avoided as a result of telemedical consultations?
Measured: up to two weeks
number of telephone and visit contacts
How many telephone and telemedical consultations have taken place?
Measured: up to two weeks
sense of safety of patients and professional users
How was the sense of security among patients and health care workers? (6-point Likert scale (values: 1 (minimum) to 6 (maximum)), lower values mean higher sense of security)
Measured: 7 and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Feb 2019
- Primary completion30 Oct 2021
- Study completion28 Feb 2022
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 CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Palliativnetz Muenster gGmbH, CompuGroup Medical
- Responsible party
- Sponsor
- Investigators
- Philipp Lenz, MD, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054048
- Sponsor's protocol ID
- EFRE-0801384
- Acronym
- oVID
- Status last verified
- Jul 2023
- First submitted
- 28 Jul 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bernhardt F, Buckmann A, Kruger J, Bauer B, Hofmeister U, Juhra C, Eveslage M, Fischhuber K, Storck M, Brix TJ, Lenz P. Telemedicine Plus Standard Care Versus Standard Care Only in Specialized Outpatient Palliative Care: A Randomized Controlled Noninferiority Trial. Telemed J E Health. 2024 May;30(5):1459-1469. doi: 10.1089/tmj.2023.0621. Epub 2024 Jan 31.
PubMed 38294865
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Video System in Medicine (oVID) - Use Case Palliative Care
- ClinicalTrials.gov ID
- NCT06054048
- Acronym / sponsor ID
- oVID / EFRE-0801384
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Palliativnetz Muenster gGmbH, CompuGroup Medical
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Sep 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.
Currently, there are no telemedical visits between patients and/or their relatives and a palliative physician for the evaluation of symptom and progress monitoring. This is done during visits of the patient by the coordinators and palliative physicians of the palliative network/PKD Münster (PKD = Palliative Care Consultation Service) and/or the general practitioners. Upon enrollment in the Palliative Network/PKD Münster, patients receive a 24-hour emergency telephone number. This is staffed by a caregiver who coordinates the deployment of other caregivers / palliative care physicians according to the information provided by the patient / family members. If patients are randomized to the "telemedicine" group, they have the option of using ELVI (ELVI = electronic visit) in addition to conventional care, and thus the possibility of televisits with physicians or nurses. In this case, they receive access data for ELVI, i.e., an access code for a virtual waiting room. In addition, patients will be given questionnaires at discharge to be completed on the day of discharge and on days 7, and 14.
The primary objective of this randomized trial is to demonstrate that telemedically managed patients are not relevantly inferior to conventionally managed patients in terms of change in Integrated Palliative care Outcome Scale (IPOS) from the day of discharge (non-inferiority question), although the possibility of televisiting may result in less frequent physician visits to the patient's home.
Detailed description
Purpose
The increasing specialization of medicine and the growing shortage of medical professionals, especially in rural areas, call for constant networking of clinical facilities. This networking is driven not least by the medical societies. For example, networks have been established throughout Germany in the care of severely injured patients, in neurology, palliative medicine, intensive care medicine, infectious diseases, cardiology and other specialist disciplines. All of these networks aim to improve the joint care of the respective patients, even across sector boundaries.
Moreover, demographic change has been inexorably causing society to age for years. A steadily growing proportion of the population is at an age when the demand for medical treatment is increasing. At the same time, there is a shortage of qualified medical personnel. By 2030, there will be a shortage of up to 106,000 physicians and 575,000 nurses. A double-digit share of all medical positions will probably not be filled. This development is felt with particular intensity in rural areas. Here, the average age of the population and thus the need for medical services, as well as the shortage of doctors and nurses, are even higher than the national average.
In the course of digitization, a wide range of opportunities are opening up that will enable greater efficiency in the treatment of many patients, especially in rural areas. However, the individual networks use heterogeneous, technical systems and standards to a varying extent for this purpose. While the exchange of image data (e.g., X-ray, CT, and MRI examinations) between individual institutions has already become standard in some regions of Germany (e.g., West German Teleradiology Network), there is no communication system that is accessible everywhere and can be used across disciplines, that can be used by every network, that offers the necessary functions, and that can also be adapted to the needs of the respective network. A connection of many different systems is made difficult by high interface, integration and process costs, and in some cases virtually impossible. A system that enables cross-clinic, interdisciplinary communication is not comprehensively available at the present time.
The question of palliative care is becoming increasingly important both in hospitals and in the outpatient setting. Recent studies have shown that palliative care can not only improve the quality of life, but also significantly improve the outcome of treatment and thus prolong survival. Patients with incurable, advanced diseases die more often in hospital than - as often desired - in the home environment. However, both the shortage of physicians and increasing urbanization make it difficult to realize this area-wide provision of palliative care, especially in rural areas. "Communication and shared decision making" and "trust and confidence in treatment partners" are the most important factors for quality end-of-life care. For patients at the end of life, a visit to a (specialist) physician and the associated transport can be a major, energy-sapping and emotional effort. By bringing together various disciplines in one place, as is the case at University Hospital Muenster, and by using telemedical rounds, it may be possible to protect resources on the patient side as well.
Currently, there are no telemedical visits between patients and/or their relatives and a palliative physician for the evaluation of symptom and progress monitoring. This is done during visits of the patient by the coordinators and palliative physicians of the palliative network/PKD Münster and/or the general practitioners. Upon enrollment in the Palliative Network/PKD Münster, patients receive a 24-hour emergency telephone number. This is staffed by a caregiver who coordinates the deployment of other caregivers / palliative care physicians according to the information provided by the patient / family members. If patients are randomized to the "telemedicine" group, they have the option of using ELVI in addition to conventional care, and thus the possibility of televisits with physicians or nurses. In this case, they receive access data for ELVI, i.e., an access code for a virtual waiting room. In addition, patients will be given questionnaires at discharge to be completed on the day of discharge and on days 7, and 14.
The primary objective of this randomized trial is to demonstrate that telemedically managed patients are not relevantly inferior to conventionally managed patients in terms of change in IPOS from the day of discharge (non-inferiority question), although the possibility of televisiting may result in less frequent physician visits to the patient's home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Active comparator | Other: TelemedicineThose patients who received specialized outpatient palliative care plus telemedicine. |
| No telemedicine (Standard of Care) | No intervention | –Those patients who received standard specialized outpatient palliative care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with indications to receive specialized palliative care for advanced malignant and non-malignant diseases
- Minimum age 18 years
- Signed informed consent
- Inpatient care in a normal ward or the palliative care unit at University Hospital Muenster
- Planned discharge to home environment
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding patients
- minors
- Language difficulties (lack of German language skills), if these cannot be compensated by family members or interpreters can be compensated
- Dependency or employment relationship to the project management or the including physician
- Persons who have been placed in an institution by court or official order
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 |
|---|---|---|
| TelemedicineWeb Real-Time Communication (WebRTC), which enables a peer-to-peer connectivity. Communication platform for all TCs was the software "CompuGroup Medical Electronic Visit" (CGM ELVI), which provides end-to-end encrypted video conferencing between physicians and their patients. | Other | Telemedicine |
Primary outcome
Symptom Control
Time frame: 7 days
Change in the Integrated Palliative Care Outcome Scale (IPOS) over the first seven days after transfer (analyzed for the randomized part of the trial in a non-inferiority analysis). The total scores using IPOS can range between 0 and 68 points. The higher the score, the more severe are the patient's symptoms. IPOS was evaluated using a paper questionnaire. seven days after transfer (analyzed for the randomized part of the trial in a non-inferiority analysis).
5 secondary outcomes
Reason for request
Time frame: up to two weeks
resulting interventions
Time frame: up to two weeks
avoidance of home visits
Time frame: up to two weeks
number of telephone and visit contacts
Time frame: up to two weeks
sense of safety of patients and professional users
Time frame: 7 and 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 38294865Bernhardt F, Buckmann A, Kruger J, Bauer B, Hofmeister U, Juhra C, Eveslage M, Fischhuber K, Storck M, Brix TJ, Lenz P. Telemedicine Plus Standard Care Versus Standard Care Only in Specialized Outpatient Palliative Care: A Randomized Controlled Noninferiority Trial. Telemed J E Health. 2024 May;30(5):1459-1469. doi: 10.1089/tmj.2023.0621. Epub 2024 Jan 31.
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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.
Philipp Lenz, MD principal investigator
University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Cancer and Chronic Heart Failure, run by University Hospital Muenster at 1 site in Germany.
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 10 inclusion and 5 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: finished, as of the sponsor's last update on 26 Sep 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Control (time frame: 7 days). 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 NCT06054048, 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 26 Sep 2023.