Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05096819 |
| Other study ID # |
PID15408 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
October 6, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Oxford University Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The six-minute walk test (6MWT) is a standard method for measuring exercise capacity in
patients with cardiopulmonary disease such as pulmonary hypertension (PAH) and measures how
far a patient can walk in 6 minutes. The test is usually performed in the hospital, by
walking along a hospital corridor. Since the outbreak of SARS-CoV-2, there has been a need to
minimise patient contact with hospitals and their staff to reduce transmission of the virus.
In a previous research project called 6APP, the investigators designed, developed and
evaluated a mobile phone app, to allow them to perform the 6MWT in the community. Given the
current circumstances, cardiovascular outpatients including patients in the PAH clinic at
Oxford University Hospitals are being recommended to use an app derived from that project to
provide their 6MWT distance to the clinical team for assessment, in addition to their
symptoms and general well-being. This is felt to be more appealing to the patients, and would
reduce the time spent in hospital on the day of their outpatient appointment.
The investigators plan to measure the usefulness of adopting remote, mobile-based 6MWT among
hospital outpatients, within the constraints imposed by the SARS-COV2 pandemic.
Description:
Since the outbreak of SARS-CoV-2, health care systems have been subject to increased
pressures. This is mainly due to infected patients being admitted to the medical wards and
intensive care units, but also due to the requirement to reduce exposure of both healthcare
professionals and patients to COVID by minimising contact.
There are indications that reduced access to healthcare services during the pandemic is
responsible for more than half of excess deaths in the United States . In response to this,
the CDC is advocating the use of telemedicine to keep providing a remote version of
healthcare services . A study of telemedicine services in China used during COVID-19 pandemic
showed that they reduced burden on hospitals, prevented overcrowding, reduced the risk of
cross-infection, and relieved patients' anxiety . The use of telemedicine is also being
developed in Europe, where many patients are being denied the use of clinical services, like
cardiac rehabilitation , because of centres being closed. In the context of the NHS, an
increased use of telemedicine services is being observed . The NHS long-term plans do, in
fact, include tele-consultations as a pillar for its sustainability . Healthwatch have
produced useful advice for outpatient clinicians to consider avoiding asking patients to
attend physical outpatient appointments where a clinically-appropriate and accessible
alternative exists. Where an appointment is clinically necessary, the national benchmark is
that at least 25% could be conducted by telephone or video including 60% of all follow-up
appointments. Initial promising results are being seen in the context of diabetes, where
virtual clinics are recommended as mitigation to the pandemic .
5.2. The 6MWT To assess patient's exercise capacity, the six-minute walk test (6MWT) is a
standard method used in patients with cardiopulmonary disease such as Heart Failure (HF) or
Pulmonary arterial Hypertension (PAH). The 6MWT measures how far a patient can walk in 6
minutes. Walking is an activity performed every day, by most patients except for those most
severely limited. By assessing patients' ability to exercise, the 6MWT provides a global
assessment of respiratory, cardiovascular, neuromuscular and cognitive function. The 6MWT
does not differentiate what limits the patient, nor does it assess maximal exercise capacity.
Instead, the 6MWT allows the patient to exercise at a daily functional level, and is a useful
tool for assessing changes after a therapeutic intervention, and correlates with a subjective
improvement in dyspnoea .
In PAH the 6MWT is used to evaluate patients' response to treatment, with an increase in 6MWT
distance of greater than 42 m being considered a clinically significant improvement .
Furthermore, change in 6MWT distance correlates with VO2 max, NYHA class and mortality in
those patients, providing an objective assessment of disease progression, prognosis and
response to treatment. It is a universally accepted test as it is safe and easily performed
by the patient.
5.3. Cardiovascular outpatient management during the pandemic Since the outbreak of
SARS-CoV-2, the standard regime of care for outpatients with cardiovascular disease has been
affected.
For example, in PAH patients, the normal regime of a 6MWT, echocardiogram and face to face
consultation was abandoned as those patients were felt to be extremely clinically vulnerable,
and therefore were recommended to shield at home. Therefore patients needed to be assessed
without having any face to face contact, unless in an emergency. This situation continued for
five months until August, when shielding was initially withdrawn, however we are now back in
this situation with a highly transmissible variant SARS-CoV-2. Therefore the need to reduce
time spent in hospital continues as the virus continues within the community.
In cardiovascular outpatient clinics in Oxford, patients are now being regularly contacted by
phone to replace face to face visits. During these phone calls, questions about the general
status of the patient are asked, i.e. how far they think they can walk and whether they have
noticed a change in their exercise capacity or functional capacity, but currently no
objective data, like the results of the 6MWT, are available for assessment.
5.4. Telemedicine services for pulmonary hypertension In a previous research project called
6APP, we designed, developed and evaluated a mobile-health "app" (a type of telemedicine
where patients use their mobile phones), to allow them to perform the 6MWT in the community.
We hypothesized that a test conducted by patients, in their environment, would reflect more
the patient's functional status, would free up healthcare resources and would be less
stressful and costly for the patients themselves.
The app allowed patients to perform the test both indoors, by walking back and forth along a
corridor of fixed length, and outdoors, using the localization system (like the GPS). In our
study with 30 PAH patients, we proved that the app is accurate when used outdoors, the
measurements are reliable and repeatable and the method is well-accepted by patients .
After these encouraging results, the app has been simplified and made available for free for
both Android and iPhones under the name of "Timed Walk". The original app was developed by
Dario Salvi at the Institute of Biomedical Engineering of the Oxford University. The current
app, which uses the same validated outdoors test approach, is instead maintained by the
University of Malmo, Sweden, where Dr. Salvi is currently employed.
Given the current circumstances, the PH clinic in Oxford and other cardiovascular outpatient
clinics are recommending patients to use the Timed Walk app, the results of which are being
used by the clinical team to assess patients in addition to their symptoms and general
well-being. This is felt to be more appealing to the patients, and would reduce the time
spent in hospital on the day of their outpatient appointment. The app only allows outdoor
tests (as these proved to be more reliable and practical) and to share 6MWT data via email if
patients want to.
