Trial Outcomes & Findings for Evaluation of a New 6 Minute Walk Test Smartphone App in Patients With Pulmonary Hypertension (NCT NCT04633538)

Results Overview

Percentage of participants who perform app-based home 6MWT.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

6 months

Results posted on

2025-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	6MWT App Group Patients who received the 6MWT app and performed tests at the clinic and in the community using the app
Overall Study STARTED	30
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	6MWT App Group Patients who received the 6MWT app and performed tests at the clinic and in the community using the app
Overall Study Death	1
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	6MWT App Group n=30 Participants Patients who received the 6MWT app and performed tests at the clinic and in the community using the app
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=30 Participants
Age, Categorical >=65 years	7 Participants n=30 Participants
Age, Continuous	50 years n=30 Participants
Sex: Female, Male Female	11 Participants n=30 Participants
Sex: Female, Male Male	19 Participants n=30 Participants

PRIMARY outcome

Timeframe: 6 months

Percentage of participants who perform app-based home 6MWT.

Outcome measures

Outcome measures
Measure	6MWT App Group n=30 Participants Patients who received the 6MWT app and performed tests at the clinic and in the community using the app
Percentage of Participants Who Perform App-based Home 6MWT	30 Participants

SECONDARY outcome

Timeframe: At start, at month 3 and at month 6.

Population: 6MWT distances differences between conventional 6MWT in clinic, and using the app in indoor mode, simultaneously

Comparison of the indoor app-based 6MWD against simultaneous clinic 6MWD: mean and standard deviation of the difference in distance as measured by physiologists and the app. Differences at 3 time points (start, month 3 and month 6) are lumped together in the calculation of the statistics (mean and standard deviation).

Outcome measures

Outcome measures
Measure	6MWT App Group n=70 Pairs of 6MWT distances Patients who received the 6MWT app and performed tests at the clinic and in the community using the app
Difference in Walked Distance Between 6MWT Test at the Clinic as Measured by Physiologists and the App in Indoor Mode	14.6 metre Standard Deviation 75.48

SECONDARY outcome

Timeframe: Clinic tests at start, at month 3, at month 6. Community tests undertaken within 7 days of clinic test.

Population: Difference of 6MWT distances, between conventional 6MWT in clinic, and using the app in outdoor mode in the community, within 7 days from clinic 6MWT

Comparison of pairs of 6MWT distance estimates where one is the result of an observation done by a physiologist in a clinic (start, month 3 and month 6) and the other is measured by the app during an outdoor test performed within 7 days of the physiologist's observation. Measurements at 3 time points (start, month 3 and month 6) are lumped together in the calculation of the statistics (mean and standard deviation).

Outcome measures

Outcome measures
Measure	6MWT App Group n=69 Pairs of 6MWT distances Patients who received the 6MWT app and performed tests at the clinic and in the community using the app
Difference in Walked Distance Between 6MWT Test as Measured by Physiologists at the Clinic and App in Outdoor Mode at the Community	2.45 metre Standard Deviation 47.0

SECONDARY outcome

Timeframe: 6MWT in the community, at the patient's discretion (recommended once/month), over 6 months

Population: Pairs of outdoor tests performed by the same patient no more than 7 days apart

Intraclass correlation of app-base tests in outdoor mode in the community, measured over pairs of outdoor tests performed by the same patient no more than 7 days apart.

Outcome measures

Outcome measures
Measure	6MWT App Group n=89 Pairs of 6MWT distances Patients who received the 6MWT app and performed tests at the clinic and in the community using the app
Test-Retest Reliability of Community-Based 6MWT	0.91 ICC

SECONDARY outcome

Timeframe: At month 6

Percentage of patients who performed at least 1 app-based 6MWT in the community per month

Outcome measures

Outcome measures
Measure	6MWT App Group n=25 Participants Patients who received the 6MWT app and performed tests at the clinic and in the community using the app
Compliance to Monitoring Regime in the Community	12 Participants

Adverse Events

6MWT App Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Elizabeth Orchard

Oxford University Hospital

Phone: 01865223084

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place