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 (6-APPnow)

• ClinicalTrials.gov Identifier: NCT05096819
• Recruitment Status: Recruiting
• First Posted: October 27, 2021
• Last Update Posted: January 31, 2023
• Sponsor: Oxford University Hospitals NHS Trust
• Collaborator: Malmö University
• Information provided by (Responsible Party): Elizabeth Orchard, Oxford University Hospitals NHS Trust

Tracking Information

• First Submitted Date: June 5, 2021
• First Posted Date: October 27, 2021
• Last Update Posted Date: January 31, 2023
• Actual Study Start Date: September 1, 2021
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 25, 2021)

Number of patients undertaking a 6MWT. [ Time Frame: 12 months ]

Percentage of participants who perform at least one app-based 6MWT before patient consultation.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 25, 2021)

• To measure the accuracy of the app-based measurement. [ Time Frame: 1 year ]
  Comparison of walked distance (6MWD) measured by the app versus a trundle wheel reference.
• To measure differences in distance walked according to the app altered management of patients. [ Time Frame: 1 year ]
  Number of clinical investigations and multidisciplinary team discussions triggered by variations in app-based 6MWD.
• Did the patients use the app [ Time Frame: 1 year ]
  Standard usability and acceptance questionnaires, semi-structured interviews. The questionnaire will be based on the validated and widely used uMARS questionnaire and the Mobile Health Technology Acceptance Model (MoHTAM) questionnaire .
• To determine whether the use of the 6MWT reduces time spent and number in hospital visits. [ Time Frame: 1 year ]
  Time spent in hospital attendances and number of hospital visits made during use of the 6MWT compared with previous periods.
• Number of patients undertaking a 6MWT during the pandemic period [ Time Frame: 1 year ]
  Total number of 6MWTs performed during 2020 pandemic period compared with pre-pandemic period.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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

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.

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 .

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.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All patients under the care of the cardiovascular clinics in Oxford, who are able to walk and use a smartphone
• Condition: Pulmonary Hypertension

Intervention

Other: App

Use of an App to measure 6MWT distance

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 25, 2021): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2023
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Being enrolled in Oxford clinics
• Owning or having access to a smartphone with either Android or iOS
• Being able to use a smartphone app
• Being able to walk

Exclusion Criteria:

• Long term oxygen therapy
• Cognitive impairments
• Cannot use a smartphone
• Pregnancy
• Not able to complete a 6MWT
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Elizabeth Orchard, MA, MBBS, FRCP; 07956184144; elizabeth.orchard@ouh.nhs.uk

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT05096819
• Other Study ID Numbers: PID15408
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Elizabeth Orchard, Oxford University Hospitals NHS Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Oxford University Hospitals NHS Trust
• Original Study Sponsor: Same as current
• Collaborators: Malmö University

Investigators

• Principal Investigator: Elizabeth Orchard, MA, MBBS, FRCP; Oxford University Hospitals NHS Trust

• PRS Account: Oxford University Hospitals NHS Trust
• Verification Date: January 2023