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
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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|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
- Other: App
Use of an App to measure 6MWT distance
- Number of patients undertaking a 6MWT. [ Time Frame: 12 months ]Percentage of participants who perform at least one app-based 6MWT before patient consultation.
- 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.
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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|
- 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
- Long term oxygen therapy
- Cognitive impairments
- Cannot use a smartphone
- 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.
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
|Contact: Elizabeth Orchard, MA, MBBS, FRCPfirstname.lastname@example.org|
|Oxford University Hospitals NHS Foundation Trust||Recruiting|
|Oxford, United Kingdom|
|Contact: Elizabeth Orchard|
|Principal Investigator:||Elizabeth Orchard, MA, MBBS, FRCP||Oxford University Hospitals NHS Trust|
|Responsible Party:||Elizabeth Orchard, Primary Investigator, Oxford University Hospitals NHS Trust|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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