Virtual Care in CF (VIRTUAL-CF) Study

NCT ID: NCT03069651

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-29
• Study Completion Date: 2020-12-31

Brief 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 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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Care

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.

Group Type: ACTIVE_COMPARATOR

Virtual Care

Intervention Type: OTHER

The use of Videoconferencing software to enable remote access to monitor patients in the 'Virtual Care' cohort.

Routine Care

Usual clinical care.

Group Type: PLACEBO_COMPARATOR

Virtual Care

Intervention Type: OTHER

The use of Videoconferencing software to enable remote access to monitor patients in the 'Virtual Care' cohort.

Interventions

Virtual Care

The use of Videoconferencing software to enable remote access to monitor patients in the 'Virtual Care' cohort.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. CF diagnosis confirmed by clinical characteristics, sweat test +/- genetic testing

2. Age over 18 years

3. Patient has been assessed by the clinical team to require a course of community-delivered intravenous antibiotics

4. Patients who give informed consent.

Exclusion Criteria

1. Patients who are currently participating in another clinical trial (excluding observational studies)

2. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart of England NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward F Nash, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant Physician

Locations

Birmingham Heartlands Hospital

Birmingham, West Midlands, United Kingdom

Countries

United Kingdom

Other Identifiers

2014134RM

Identifier Type: -

Identifier Source: org_study_id