Evaluation of a New 6 Minute Walk Test Smartphone App in Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— 6-APP  

Official title:

Evaluation of a New 6 Minute Walk Test Smartphone App in Patients With Pulmonary Hypertension (The 6-APP Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633538
• Other study ID #: PID13040
• Status: Completed
• Start date: January 15, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: November 2020
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Comparison of standard 6 minute walk test with 6 minute walk test smartphone app.

Description:

Pulmonary Arterial Hypertension (PAH) is a progressive illness that; if not diagnosed early or left untreated, can be a severe life limiting condition . It is a chronic disease of the pulmonary vasculature, with vascular proliferation and remodelling of the small pulmonary arteries leading to a progressive increase in pulmonary vascular resistance (PVR). This can ultimately lead to right heart failure and premature death . The predominant symptom of PAH is dyspnoea on exertion, with a decrease in exercise capacity, and most patients present with this symptom .

PAH is an uncommon condition, affecting about 6000 patients in the United Kingdom , and due to its rarity, the NHS commissions 7 centres to care for patients with PAH. Oxford University Hospital NHS Foundation Trust works closely with the Royal Brompton Hospital to provide care for patients with PAH in Oxfordshire and the surrounding region.

The six-minute walk test (6MWT) is a standard method for measuring exercise capacity in patients with cardiopulmonary disease such as PAH. The 6MWT measures how far a patient can walk in 6 minutes. Walking is an activity performed every day, by most patients except for those most severely limited. By assessing patients' ability to exercise, the 6MWT provides a global assessment of respiratory, cardiovascular, neuromuscular and cognitive function. The 6MWT does not differentiate what limits the patient, nor does it assess maximal exercise capacity. Instead, the 6MWT allows the patient to exercise at a daily functional level, and is a useful tool for assessing changes after a therapeutic intervention, and correlates with a subjective improvement in dyspnoea .

In PAH the 6MWT is used to evaluate patients' response to treatment, with an increase in 6MWT distance of greater than 42m being considered a clinically significant improvement . Furthermore, change in 6MWT distance correlates with VO2 max (maximum rate of oxygen consumption measured during exercise), NYHA class (classification of patients' daily limitation) and mortality in PAH patients, providing an objective assessment of disease progression, prognosis and response to treatment. It is a universally accepted test as it is safe and easily performed by the patient.

The 6MWT has become the primary end-point for many trials, and as a surrogate invalidated survival outcome for all placebo controlled trials of PAH therapy . It is used by regulatory bodies to determine whether a treatment should be approved. However, there is much discrepancy between whether it is the total distance walked at baseline prior to treatment, a decrease in total distance walked over time or a percentage increase in walking distance that correlates best with survival outcome. The investigators hypothesize that it is all 3 of these measures, and that having a validated and more reproducible 6MWT would help assess patients and guide treatment strategies better.

The test is usually performed in hospital, by walking along a hospital corridor, where many factors on the day of the test can affect patients' performance, including tiredness, unfamiliarity with the environment or anxiety. The test typically requires 2 physiologists to monitor the distance walked by the patient, their oxygen saturations by pulse oximetry, and to record symptoms felt during the test. To improve the assessment of a patient's exercise capacity using a 6MWT, the investigators hypothesize that the test would reflect more the patient's functional status, if it were undertaken prior to the hospital outpatient appointment. The investigators have designed a mobile-phone "app" that allows patients to perform the 6MWT within the patient's home environment. 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 6MWT app is categorised as a mobile-health (m-health) system, a form of telehealth whereby healthcare is delivered at a distance using smartphones. By utilizing biometric collection devices such as a pulse oximeter monitor with Bluetooth capability, m-health can be used to measure the oxygen saturation levels in the blood from patients, and transmit them to a secure server, allowing them to be reviewed by cardiologists and other healthcare professionals.

The evidence-base for m-health as a tool for assessing physical fitness is increasingly established. This new approach not only offers the opportunity for reliable collection of data, but provides the infrastructure to do this at scale and will allow decisions on patients' health to be based on more frequent and more accurate information.

There are no known risks to undertaking a 6MWT in the community as walking is an activity of daily living, and all patients are encouraged to walk daily.

The population to be studied will be those with PAH who are currently assessed with a 6MWT. Once the app has been validated, patients with any type of cardiorespiratory disease who are assessed with a 6MWT could use the app, for example patients with chronic obstructive airways disease, heart failure, renal failure, and pre-transplantation work up.

The 6MWT results form part of the NHS data set collected by NHS England for patients with PAH, and it would be beneficial to have a more reproducible assessment, whose results could be compared between the 7 centres providing care for these patients. At present, there is much variability in how 6MWTs are performed between units, and the app would reduce this variability.

The 6MWT has been undertaken at the John Radcliffe hospital for 5 years and the investigators will also retrospectively analyse the data from the 6MWT that have previously been undertaken. The data on patients will be pseudo-anonymised, i.e. no personal information like name, surname or address, will be used, but the investigators will keep date of birth, gender, diagnosis, dates and results of the 6MWT, date and causes of death. As part of the clinical care team, reviewing the data is part of the normal standard of care for patients with PHT. The data is collected on the Solus cardiac reporting system and can be extracted from this database. The data will be pseudo-anonymised by the Principle Investigator for analysis, and then shared with the wider research team. The data will be analysed to look at distance walked, and change in oxygen saturation and heart rate during the test. The investigators will analyse the data over time, to look for changes in these parameters and correlate these with outcome data, i.e. mortality.

The study aims at demonstrating that patients are able and willing to use the app for the 6MWT and the measurements obtained by the app are comparable to the ones obtained in hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2020
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study

• Male or Female, aged 18 years or above

• Diagnosed with PAH who are able to undertake 6MWT off-oxygen

• Being of PAH group 1 or 4

• Participant owns a compatible smartphone (Android or iPhone) and is able to use it.

Exclusion Criteria:

• Long term oxygen therapy

• Cognitive impairments

• Rheumatological diseases that limit the measurement of finger Oxygen saturations

• PAH groups 2, 3 or 5

• Cannot use a smartphone

• Pregnancy.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Device:
• Smartphone app
Use of smartphone app to measure 6 minute walk test (6MWT)

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

Agarwal R, Gomberg-Maitland M. Current therapeutics and practical management strategies for pulmonary arterial hypertension. Am Heart J. 2011 Aug;162(2):201-13. doi: 10.1016/j.ahj.2011.05.012. Epub 2011 Jul 13. Review. — View Citation

Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, Groves BM, Tapson VF, Bourge RC, Brundage BH, Koerner SK, Langleben D, Keller CA, Murali S, Uretsky BF, Clayton LM, Jöbsis MM, Blackburn SD, Shortino D, Crow JW; Primary Pulmonary Hypertension Study Group. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N Engl J Med. 1996 Feb 1;334(5):296-301. — View Citation

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. — View Citation

Galiè N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26. Erratum in: Circulation. 2011 Sep 6;124(10):e279. Dosage error in article text. — View Citation

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. — View Citation

Miyamoto S, Nagaya N, Satoh T, Kyotani S, Sakamaki F, Fujita M, Nakanishi N, Miyatake K. Clinical correlates and prognostic significance of six-minute walk test in patients with primary pulmonary hypertension. Comparison with cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):487-92. — View Citation

Tan MP, Bansal SK, Wynn NN, Umerov M, Gillham A, Henderson A, Hildreth A, Junejo S. Long term survival of patients with raised pulmonary arterial systolic pressure utilizing echocardiography-a five-year prospective study. J Geriatr Cardiol. 2012 Dec;9(4):328-35. doi: 10.3724/SP.J.1263.2012.06191. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who perform app-based home 6MWT	Percentage of participants who perform app-based home 6MWT	At 6 months
Secondary	Average and variability of the difference in distance as measured by physiologists and the app.	Mean and standard deviation of the difference in distance as measured by physiologists and the app.	At 6 months
Secondary	Relationship between outdoor 6MWT app distance with the hospital 6MWT test	Correlation of outdoor 6MWT app walking distance with the hospital 6MWT test	At 6-month OPD 6MWT compared with home test at time of OPD