Cystic FibrosisNCT03069651
Virtual Care in CF (VIRTUAL-CF) Study
A study testing Virtual Care in people with Cystic Fibrosis, run by Heart of England NHS Trust at 1 site in United Kingdom.
Trial summary
Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing recurrent chest infections (pulmonary exacerbations). People with CF experiencing pulmonary exacerbation often require a 14day course of intravenous antibiotics and this treatment can either be delivered in hospital or in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Virtual Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Mar 2016to 31 Dec 2020
- 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
- CF diagnosis confirmed by clinical characteristics, sweat test +/- genetic testing
- Age over 18 years
- Patient has been assessed by the clinical team to require a course of community-delivered intravenous antibiotics
- Patients who give informed consent.
Who cannot join
- Patients who are currently participating in another clinical trial (excluding observational studies)
- Pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract operation) in the previous 4 weeks, or any other factor that prevents measurement of spirometry
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Heartlands Hospital
Birmingham, West Midlands, B9 5SS
About this study
Official title: A Prospective Randomised Pilot Study of Videoconferencing in Adults With Cystic Fibrosis Receiving Intravenous Antibiotics for Acute Pulmonary Exacerbations (VIRTUALCF)
Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing recurrent chest infections (pulmonary exacerbations). People with CF experiencing pulmonary exacerbation often require a 14day course of intravenous antibiotics and this treatment can either be delivered in hospital or in the community. Patients admitted to hospital are seen regularly by members of the CF multidisciplinary team (MDT), including doctors, nurses, dieticians and physiotherapists. This allows patients' progress to be closely monitored and also gives patients the opportunity to discuss any concerns or questions. In contrast, patients receiving IV antibiotics in the community are only seen by the MDT at the beginning and end of their 14 day course of IV antibiotics. Although CF nurses often visit patients on 12 occasions during the course of treatment, patients are not routinely reassessed by the rest of the MDT. There is therefore less opportunity for the MDT to adjust patients' treatment and for patients to communicate with the MDT.
We therefore aim to study whether patients receiving IV antibiotics in the community benefit from monitoring their own oxygen saturations and lung function, as well as taking part in twice-weekly videoconferences with the MDT ('virtual care'). We expect that this will enable the MDT to to assess patients' progress more closely and allow patients to communicate with the MDT more easily. We will assess whether this improves patients' experience of their care and whether this translates into improvements in health and economic outcomes.
Read more
One hundred subjects will be recruited over a 12month period, with 50 subjects allocated to 'virtual care' and 50 subjects allocated to 'routine care'. Subjects receiving 'routine care' will receive usual clinical care.
The research team are well placed to perform the study because we are part of a large CF centre with an excellent record in clinical research.
Read the detailed description
Study design Subjects will be recruited and randomly allocated in a 1:1 ratio, by means of sealed envelopes, to receive either 'virtual care' or 'routine care' for the 14day course of communitydeliveredIV antibiotics. Subjects randomly allocated to receive 'virtual care' will be shown how to use the oximeter and spirometer, as well as the videoconferencing software.
'Virtual care' subjects will be asked to perform a lung function test (using the spirometer) and record their oxygen saturations (using the oximeter) twice weekly during the videoconference with the CF team. Times and dates for the videoconference will be arranged at a time that is convenient for the patient. Subjects will be able to videoconference using any internetenabled device (laptop, tablet, mobile phone) available for the patient's use, but this device will not be provided as part of the study. The videoconferencing software used for this study is Webex, which is widely used within the NHS for videoconferencing with patients and all data is fully encrypted. Subjects in both groups ('virtual care' and 'routine care') will be offered home visits by a CF nurse if required as usual and an appointment made in the outpatient clinic immediately after the course of intravenous antibiotics finishes as usual.
Both cohorts ('virtual care' and 'routine care') will be asked to complete the CFQR(a validated disease-specific health related quality of life questionnaire) at the beginning and end of their course of IV antibiotics. Subjects in both groups will also be asked to complete a satisfaction questionnaire at the end of the course of antibiotics. Patients receiving 'virtual care' will be specifically asked about the ease of use of the oxygen saturation and spirometer equipment, as well as the videoconferencing system. Data regarding participants' lung function, nutritional status and medications will be recorded during each clinic visit for both cohorts. Subjects in both cohorts will also be asked to record any costs related to their care throughout the course of treatment (e.g. travel, parking). The researchers will record the costs associated with caring for each participant (such as cost of nursing visits and staff time) and the cost of conducting the study (e.g. cost of the oxygen saturation monitor, spirometer and videoconferencing equipment).
The primary outcome is health-related quality of life (measured by CFQR) in subjects receiving 'virtual care' compared to subjects receiving 'routine care'. Our null hypothesis is that there will be no significant difference in the CFQR in subjects receiving 'virtual care' compared to subjects receiving 'routine care'. Secondary outcomes are: patient satisfaction with care, days on intravenous antibiotics, lung function and weight in subjects receiving 'virtual care' compared to subjects receiving 'routine care'. A health economic analysis will be conducted to determine whether 'virtual care' is value for money both from an NHS and a patient perspective.
- Conditions
- Cystic Fibrosis
- Being tested
- Virtual Care
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual CareOther
The use of Videoconferencing software to enable remote access to monitor patients in the 'Virtual Care' cohort.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Care | Active comparator | Subjects randomly allocated to receive 'virtual care' will be shown how to use the oximeter and spirometer, as well as the videoconferencing software.
'Virtual care' subjects will be asked to perform a lung function test (using the spirometer) and record their oxygen saturations (using the oximeter) twice weekly during the videoconference with the CF team. Receives: Other: Virtual Care |
| Routine Care | Placebo comparator | Usual clinical care. Receives: Other: Virtual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does 'virtual care' affect health-related quality of life in CF adults receiving IV antibiotics?
Participants allocated to 'Virtual Care' will be asked to measure their oxygen saturations ( using the oximeter provided) and measure their lung function (using the spirometer provided) during the the twice-weekly video conferences with the CF MDT. Participants allocated to 'routine care will continue to receive standard care.
Measured: 12 months
Secondary outcomes (4)
Patient satisfaction with 'virtual care' compared to 'routine care'
Participant in both groups will be asked to complete a CF questionnaire at the beginning and end of their course of IV antibiotics and also complete a satisfaction questionnaire at the end of their IV antibiotic course
Measured: 12 months
Changes in lung function in subjects receiving 'virtual care' compared to 'routine care'
Lung function for both groups will be monitored throughout their time in the study to see if the 'virtual care' has any impact.
Measured: 12 months
Changes in weight in subjects receiving 'virtual care' compared to 'routine care'
Weight for both groups will be monitored throughout their time in the study to see if the 'virtual care' has any impact.
Measured: 12 months
Health economic analysis of 'virtual care' compared to 'routine care' from a patient and NHS perspective.
The data from both groups will be analysed to see if the experience of the participants translates into health and economic outcomes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start29 Mar 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart of England NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward F Nash, MD, Principal investigator, Consultant Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069651
- Sponsor's protocol ID
- 2014134RM
- Status last verified
- Feb 2020
- First submitted
- 9 Dec 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Pilot Study of Videoconferencing in Adults With Cystic Fibrosis Receiving Intravenous Antibiotics for Acute Pulmonary Exacerbations (VIRTUALCF)
- ClinicalTrials.gov ID
- NCT03069651
- Acronym / sponsor ID
- 2014134RM
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heart of England NHS TrustUniversity, hospital or other
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Mar 2017 (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.
Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing recurrent chest infections (pulmonary exacerbations). People with CF experiencing pulmonary exacerbation often require a 14day course of intravenous antibiotics and this treatment can either be delivered in hospital or in the community. Patients admitted to hospital are seen regularly by members of the CF multidisciplinary team (MDT), including doctors, nurses, dieticians and physiotherapists. This allows patients' progress to be closely monitored and also gives patients the opportunity to discuss any concerns or questions. In contrast, patients receiving IV antibiotics in the community are only seen by the MDT at the beginning and end of their 14 day course of IV antibiotics. Although CF nurses often visit patients on 12 occasions during the course of treatment, patients are not routinely reassessed by the rest of the MDT. There is therefore less opportunity for the MDT to adjust patients' treatment and for patients to communicate with the MDT.
We therefore aim to study whether patients receiving IV antibiotics in the community benefit from monitoring their own oxygen saturations and lung function, as well as taking part in twice-weekly videoconferences with the MDT ('virtual care'). We expect that this will enable the MDT to to assess patients' progress more closely and allow patients to communicate with the MDT more easily. We will assess whether this improves patients' experience of their care and whether this translates into improvements in health and economic outcomes.
One hundred subjects will be recruited over a 12month period, with 50 subjects allocated to 'virtual care' and 50 subjects allocated to 'routine care'. Subjects receiving 'routine care' will receive usual clinical care.
The research team are well placed to perform the study because we are part of a large CF centre with an excellent record in clinical research.
Detailed description
Study design Subjects will be recruited and randomly allocated in a 1:1 ratio, by means of sealed envelopes, to receive either 'virtual care' or 'routine care' for the 14day course of communitydeliveredIV antibiotics. Subjects randomly allocated to receive 'virtual care' will be shown how to use the oximeter and spirometer, as well as the videoconferencing software.
'Virtual care' subjects will be asked to perform a lung function test (using the spirometer) and record their oxygen saturations (using the oximeter) twice weekly during the videoconference with the CF team. Times and dates for the videoconference will be arranged at a time that is convenient for the patient. Subjects will be able to videoconference using any internetenabled device (laptop, tablet, mobile phone) available for the patient's use, but this device will not be provided as part of the study. The videoconferencing software used for this study is Webex, which is widely used within the NHS for videoconferencing with patients and all data is fully encrypted. Subjects in both groups ('virtual care' and 'routine care') will be offered home visits by a CF nurse if required as usual and an appointment made in the outpatient clinic immediately after the course of intravenous antibiotics finishes as usual.
Both cohorts ('virtual care' and 'routine care') will be asked to complete the CFQR(a validated disease-specific health related quality of life questionnaire) at the beginning and end of their course of IV antibiotics. Subjects in both groups will also be asked to complete a satisfaction questionnaire at the end of the course of antibiotics. Patients receiving 'virtual care' will be specifically asked about the ease of use of the oxygen saturation and spirometer equipment, as well as the videoconferencing system. Data regarding participants' lung function, nutritional status and medications will be recorded during each clinic visit for both cohorts. Subjects in both cohorts will also be asked to record any costs related to their care throughout the course of treatment (e.g. travel, parking). The researchers will record the costs associated with caring for each participant (such as cost of nursing visits and staff time) and the cost of conducting the study (e.g. cost of the oxygen saturation monitor, spirometer and videoconferencing equipment).
The primary outcome is health-related quality of life (measured by CFQR) in subjects receiving 'virtual care' compared to subjects receiving 'routine care'. Our null hypothesis is that there will be no significant difference in the CFQR in subjects receiving 'virtual care' compared to subjects receiving 'routine care'. Secondary outcomes are: patient satisfaction with care, days on intravenous antibiotics, lung function and weight in subjects receiving 'virtual care' compared to subjects receiving 'routine care'. A health economic analysis will be conducted to determine whether 'virtual care' is value for money both from an NHS and a patient perspective.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Care | Active comparator | Other: Virtual CareSubjects randomly allocated to receive 'virtual care' will be shown how to use the oximeter and spirometer, as well as the videoconferencing software. 'Virtual care' subjects will be asked to perform a lung function test (using the spirometer) and record their oxygen saturations (using the oximeter) twice weekly during the videoconference with the CF team. |
| Routine Care | Placebo comparator | Other: Virtual CareUsual clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CF diagnosis confirmed by clinical characteristics, sweat test +/- genetic testing
- Age over 18 years
- Patient has been assessed by the clinical team to require a course of community-delivered intravenous antibiotics
- Patients who give informed consent.
Key exclusion criteria (2 listed)
- Patients who are currently participating in another clinical trial (excluding observational studies)
- Pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract operation) in the previous 4 weeks, or any other factor that prevents measurement of spirometry
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 |
|---|---|---|
| Virtual CareThe use of Videoconferencing software to enable remote access to monitor patients in the 'Virtual Care' cohort. | Other | Routine Care, Virtual Care |
Primary outcome
Does 'virtual care' affect health-related quality of life in CF adults receiving IV antibiotics?
Time frame: 12 months
Participants allocated to 'Virtual Care' will be asked to measure their oxygen saturations ( using the oximeter provided) and measure their lung function (using the spirometer provided) during the the twice-weekly video conferences with the CF MDT. Participants allocated to 'routine care will continue to receive standard care.
4 secondary outcomes
Patient satisfaction with 'virtual care' compared to 'routine care'
Time frame: 12 months
Changes in lung function in subjects receiving 'virtual care' compared to 'routine care'
Time frame: 12 months
Changes in weight in subjects receiving 'virtual care' compared to 'routine care'
Time frame: 12 months
Health economic analysis of 'virtual care' compared to 'routine care' from a patient and NHS perspective.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- 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.
Edward F Nash, MD principal investigator
Consultant Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Care in people with Cystic Fibrosis, run by Heart of England NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 2 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 11 Feb 2020. 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 Kingdom. 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?
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?
Does 'virtual care' affect health-related quality of life in CF adults receiving IV antibiotics? (time frame: 12 months). 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 11 Feb 2020.