Ignite Creation Date:
2024-05-06 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05096819
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2021-06-05
Brief Title:
Evaluation of the Usefulness of Adopting Remote Mobile-based 6MWT Among Hospital Outpatients the 6-APPnow Within the Constraints Imposed by the SARS-COV2 Pandemic
Sponsor:
Oxford University Hospitals NHS Trust
Organization:
Oxford University Hospitals NHS Trust
Study Overview
Official Title:
Evaluation of the Usefulness of Adopting Remote Mobile-based 6MWT Among Hospital Outpatients the 6-APPnow Within the Constraints Imposed by the SARS-COV2 Pandemic
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
6-APPnow
Brief 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
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
Detailed 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
52 The 6MWT To assess patients 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
53 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 ie 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
54 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 patients 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
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
52 The 6MWT To assess patients 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
53 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 ie 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
54 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None