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

NCT05096819 | Completed Results

• 1 other identifier: PID15408
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of Patients Undertaking an App-based 6MWT

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

  At 3, 6, 9 and 12 months after the start of the study

Secondary Outcomes (4)

• Accuracy of the App-based 6MWT Distance Measurement

  1 year

• Number and Percentage of Logged Events That Were Triggered by Variations in the App-based 6MWD

  At 3, 6, 9 and 12 months after the start of the study

• Usability and Acceptance of the App

  12 months

• Comparison of 6MWT During Pandemic and Pre-pandemic

  2018 (12 months, retrospectively collected) and 2022 (12 months)

Interventions

Patients Using the 6MWT App in the Community OTHER

Patients under the care of the cardiovascular clinics in Oxford, who used the Timed Walk app to perform 6MWT in their community during the CODIV19 pandemic period

Volunteers for 6MWT distance comparison OTHER

Volunteers (cardiac patients and hospital staff) who performed 10 6MWT using the TimedWalk app and a trundle wheel simultaneously. Five tests were performed following instructions and 5 were performed introducing errors. Aim is to measure app accuracy under different circumstances.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• Malmö University: collaborator

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Related Publications (9)

• Woolf SH, Chapman DA, Sabo RT, Weinberger DM, Hill L. Excess Deaths From COVID-19 and Other Causes, March-April 2020. JAMA. 2020 Aug 4;324(5):510-513. doi: 10.1001/jama.2020.11787.

  PMID: 32609307 BACKGROUND

• Liu L, Gu J, Shao F, Liang X, Yue L, Cheng Q, Zhang L. Application and Preliminary Outcomes of Remote Diagnosis and Treatment During the COVID-19 Outbreak: Retrospective Cohort Study. JMIR Mhealth Uhealth. 2020 Jul 3;8(7):e19417. doi: 10.2196/19417.

  PMID: 32568722 BACKGROUND

• Alderwick H, Dixon J. The NHS long term plan. BMJ. 2019 Jan 7;364:l84. doi: 10.1136/bmj.l84.

  PMID: 30617185 BACKGROUND

• Quinn LM, Davies MJ, Hadjiconstantinou M. Virtual Consultations and the Role of Technology During the COVID-19 Pandemic for People With Type 2 Diabetes: The UK Perspective. J Med Internet Res. 2020 Aug 28;22(8):e21609. doi: 10.2196/21609.

  PMID: 32716898 BACKGROUND

• Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.

  PMID: 12890299 BACKGROUND

• Gabler NB, French B, Strom BL, Palevsky HI, Taichman DB, Kawut SM, Halpern SD. Validation of 6-minute walk distance as a surrogate end point in pulmonary arterial hypertension trials. Circulation. 2012 Jul 17;126(3):349-56. doi: 10.1161/CIRCULATIONAHA.112.105890. Epub 2012 Jun 13.

  PMID: 22696079 BACKGROUND

• Mathai SC, Puhan MA, Lam D, Wise RA. The minimal important difference in the 6-minute walk test for patients with pulmonary arterial hypertension. Am J Respir Crit Care Med. 2012 Sep 1;186(5):428-33. doi: 10.1164/rccm.201203-0480OC. Epub 2012 Jun 21.

  PMID: 22723290 BACKGROUND

• Salvi D, Poffley E, Orchard E, Tarassenko L. The Mobile-Based 6-Minute Walk Test: Usability Study and Algorithm Development and Validation. JMIR Mhealth Uhealth. 2020 Jan 3;8(1):e13756. doi: 10.2196/13756.

  PMID: 31899457 BACKGROUND

• Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.

  PMID: 27287964 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The study did not employ a control group, therefore it is impossible to ascertain if patients would have received the same level of care without the use of the app. This study was conducted under special circumstances due to the restrictions imposed during the COVID 19 pandemic. In that period patients may have been keener to use telemedicine to ensure they were being followed up. The results obtained may therefore not generalize outside of those circumstances.

Results Point of Contact

• Title: Dr Elizabeth Orchard
• Organization: Oxford University Hospitals

elizabeth.orchard@ouh.nhs.uk

01865 741166

Study Officials

• Elizabeth Orchard, MA, MBBS, FRCP

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: October 27, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: October 6, 2023
• Last Updated: July 22, 2025
• Results First Posted: July 22, 2025

Record last verified: 2025-07

Locations

GB (1)