Virtual Care in CF (VIRTUAL-CF) Study

NCT03069651 | Unknown

• 1 other identifier: 2014134RM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (4)

• Patient satisfaction with 'virtual care' compared to 'routine care'

  12 months

• Changes in lung function in subjects receiving 'virtual care' compared to 'routine care'

  12 months

• Changes in weight in subjects receiving 'virtual care' compared to 'routine care'

  12 months

• Health economic analysis of 'virtual care' compared to 'routine care' from a patient and NHS perspective.

  12 months

Study Arms (2)

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.

Other: Virtual Care

Routine Care

PLACEBO COMPARATOR

Usual clinical care.

Other: Virtual Care

Interventions

Virtual Care OTHER

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

Routine Care; Virtual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart of England NHS Trust: lead

Study Sites (1)

Birmingham Heartlands Hospital

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Edward F Nash, MD

  Consultant Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: March 3, 2017
• Study Start: March 29, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)