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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)

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

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.

Condition or disease Intervention/treatment
Pulmonary Hypertension Other: App

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: App
    Use of an App to measure 6MWT distance

Primary Outcome Measures :
  1. Number of patients undertaking a 6MWT. [ Time Frame: 12 months ]
    Percentage of participants who perform at least one app-based 6MWT before patient consultation.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 .

  4. 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.

  5. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05096819

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

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United Kingdom
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom
Contact: Elizabeth Orchard         
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Malmö University
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Principal Investigator: Elizabeth Orchard, MA, MBBS, FRCP Oxford University Hospitals NHS Trust
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Responsible Party: Elizabeth Orchard, Primary Investigator, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT05096819    
Other Study ID Numbers: PID15408
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases