Trial Outcomes & Findings for 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 (NCT NCT05096819)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

67 participants

Primary outcome timeframe

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

Results posted on

2025-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Using the 6MWT App in the Community Patients invited to use the TimedWalk app to perform 6MWT in the community during the COVID19 pandemic period	Volunteers for 6MWT Distance Comparison Volunteers, patients and staff, who performed additional tests to validate the accuracy of the app
Overall Study STARTED	55	12
Overall Study COMPLETED	52	12
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Using the 6MWT App in the Community Patients invited to use the TimedWalk app to perform 6MWT in the community during the COVID19 pandemic period	Volunteers for 6MWT Distance Comparison Volunteers, patients and staff, who performed additional tests to validate the accuracy of the app
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Using the 6MWT App in the Community n=55 Participants Patients invited to use the TimedWalk app to perform 6MWT in the community during the COVID19 pandemic period	Volunteers for 6MWT Distance Comparison Demographics data was not collected for this group. Nine of the volunteers were patients involved in the study, three were healthy subjects from the hospital staff.	Total n=55 Participants Total of all reporting groups
Age, Continuous	44.80 years STANDARD_DEVIATION 17.49 • n=55 Participants	—	44.80 years STANDARD_DEVIATION 17.49 • n=55 Participants
Sex: Female, Male Female	25 Participants n=55 Participants	—	25 Participants n=55 Participants
Sex: Female, Male Male	30 Participants n=55 Participants	—	30 Participants n=55 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Patients Using the 6MWT App in the Community n=55 Participants Patients invited to use the TimedWalk app to perform 6MWT in the community during the COVID19 pandemic period
Number of Patients Undertaking an App-based 6MWT	24 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Difference in 6MWT distance as measured by the app versus as measured by the trundle wheel, used simultaneously

Measurement of walked distance (6MWD) measured by the app compared with a trundle wheel reference: conventional tests where users followed instructions (walking on straight paths, avoiding tall structures), unconventional tests where users were free to move as they preferred

Outcome measures

Outcome measures
Measure	Patients Using the 6MWT App in the Community n=107 Pairs of 6MWT distances (app vs ref) Patients invited to use the TimedWalk app to perform 6MWT in the community during the COVID19 pandemic period
Accuracy of the App-based 6MWT Distance Measurement conventional tests	3.6 metre Standard Deviation 15.8
Accuracy of the App-based 6MWT Distance Measurement unconventional tests	73.0 metre Standard Deviation 122.8
Accuracy of the App-based 6MWT Distance Measurement all tests	37.4 metre Standard Deviation 92.7

SECONDARY outcome

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

Population: Percentage of clinical investigations and multidisciplinary team discussions where variations in app-based 6MWD was a contributing factor

Number (and percentage) of clinical investigations and multidisciplinary team discussions (partially) triggered by variations in app-based 6MWD

Outcome measures

Outcome measures
Measure	Patients Using the 6MWT App in the Community n=51 Logged events Patients invited to use the TimedWalk app to perform 6MWT in the community during the COVID19 pandemic period
Number and Percentage of Logged Events That Were Triggered by Variations in the App-based 6MWD	21 Logged events

SECONDARY outcome

Timeframe: 12 months

Population: Answers to uMARS questionnaire and Technology Acceptance Model, Likert scale 1 to 5 with 1 being most negative and 5 being most positive

uMARS usability questionnaire and Technology Acceptance questionnaire. Reported average for all dimensions on a 1 to 5 scale with 1 being most negative and 5 being most positive

Outcome measures

Outcome measures
Measure	Patients Using the 6MWT App in the Community n=25 Participants Patients invited to use the TimedWalk app to perform 6MWT in the community during the COVID19 pandemic period
Usability and Acceptance of the App uMARS	3.89 Scores on a scale Standard Deviation 0.97
Usability and Acceptance of the App TAM	3.75 Scores on a scale Standard Deviation 0.97

SECONDARY outcome

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

Population: Comparison of a pre-pandemic year (2018) and 2022 in terms of 6MWT performed on the study cohort. The tests in 2022 include the ones performed in clinic and the ones performed with the app.

Number of 6MWTs performed during in 2018 in clinic (collected retrospectively, after enrollment), and number of tests performed in 2022 in clinic and with the app, for the same cohort.

Outcome measures

Outcome measures
Measure	Patients Using the 6MWT App in the Community n=49 Participants Patients invited to use the TimedWalk app to perform 6MWT in the community during the COVID19 pandemic period
Comparison of 6MWT During Pandemic and Pre-pandemic 2018 at clinic	17 6MWT
Comparison of 6MWT During Pandemic and Pre-pandemic 2022 at clinic and with app	600 6MWT

Adverse Events

Patients Using the 6MWT App in the Community

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Volunteers for 6MWT Distance Comparison

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Elizabeth Orchard

Oxford University Hospitals

Phone: 01865 741166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place