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AsthmaNCT05830318

Usability and Acceptability Study of the P-STEP Mobile Application

An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by University of Leicester at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Assess the usability and acceptance of the P-STEP app, through allowing participants with specific chronic conditions to pilot the app for 12-weeks. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
P-STEP Mobile Application
How many people
178 participants
Where
1 siteUnited Kingdom
Study dates
23 Aug 2023to 31 Mar 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Potential participants will be identified and recruited on a voluntary basis exclusively from the EXCEED cohort study. A longitudinal cohort study based in Leicester, UK.

Who may be able to join

  • Adult ≥ 18 years
  • Live within the boundaries of the test site (Leicester, UK).
  • Diagnosed with one (or more) of the following conditions: asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), coronary heart disease (CHD), heart failure (HF), type 2 diabetes
  • Android smartphone which has access to the internet
  • Can walk outside for a minimum of 5 minutes without feeling uneasy/unsteady
  • Available to pilot the app for 12 weeks from August-December 2023
  • Able to give informed consent to participate in the evaluation

Who cannot join

  • English language restriction
  • Advised not to do exercise by a health care professional, in the last 12 months.
  • Access to an iOS smartphone only
  • Diagnosed with dementia, learning disability, mental health disorders (other than depression or anxiety), epilepsy
  • Receiving palliative care
  • Pregnant
Show all 10Show fewer
  • Chest pain at rest
  • Unsteady when standing or walking
  • Current cancer patient
  • Part of the P-STEP User Engagement group

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Leicester

    Leicester

Other trials in United Kingdom

About this study

Assess the usability and acceptance of the P-STEP app, through allowing participants with specific chronic conditions to pilot the app for 12-weeks.

Read the detailed description

Participants are asked to use mobile app for 12 weeks \& complete baseline, 6 week and 12 week assessments.

Being tested
P-STEP Mobile Application
Keywords
Exercise, Pollution, Air Quality
Medical subject headings
Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Coronary Disease, Heart Failure, Diabetes Mellitus, Type 2, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P-STEP Mobile ApplicationOther

    A mobile application that allows you track your walking habits while keeping you up to date with air quality information.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. System Usability Scale

    the System Usability Scale (SUS) at 12 weeks. The SUS a validated scale and a popular instrument for assessing perceived usability. There are 10 items in total, 5 with a positive tone and 5 with a negative tone, the response of each ranging from strongly disagree to strongly agree. The participant's scores will be transformed onto a 0-100 scale. General guidance suggests a SUS score 68 and above to be considered above average and below 68 is below average. Scores range from 0-100, a higher score indicates higher usability.

    Measured: 12 weeks

Secondary outcomes (11)

  1. Usability of P-STEP App

    Other than the SUS, 9 usability questions relating to the specific features of the app will be asked. Participants will also be asked to provide their general feedback on the app as well as how much they used it. Individual items in the questionnaire will be summarised with percentages. Scores range from 1-5, a higher score indicates higher usability.

    Measured: 12 weeks

  2. User Engagement Scale Short Form

    The User Engagement Scale - Short Form (UES-SF) is a reliable a valid questionnaire containing twelve items that measure user engagement categorised into; focused attention, perceived usability, aesthetic appeal, and reward. These categories can be calculated to get an average of the scores. An overall user engagement score can be calculated with UES-SF by adding together all 12 items and dividing them equally. Scores are presented on a scale 1-5. The items can be averaged into 4 categories or averaged for an overall score. Scores range from 0-60, a higher score indicates higher user engagement.

    Measured: 12 weeks

  3. SF-12 Health Questionnaire

    The short form 12 item (SF-12v2) health survey measures functional health and well-being from the participant's perspective. It assesses eight domains; physical functioning, physical role, pain, general health, vitality, social functioning, social role, mental health. Each domain contributes to two summary scores; physical component summary (PCS) and mental component summary (MCS). SF-12v2 responses will be scored and interpreted using the SF-12v2 user guide. The 8 domains will generate two summary scores; physical component score (PCS) and mental component score (MCS). Scores for the PCS and MCS range from 0-100, a higher score indicates a higher quality of life.

    Measured: 12 weeks

  4. Recent Physical Activity Questionnaire

    The RPAQ is designed to find out about a participant's physical activity in their everyday life. The RPAQ will be scored and interpreted using the scoring guidelines published by the Authors. All activities are categorised with respect to their intensity, on a scale of sedentary (<1.5), light (1.5-<3), moderate (3-6) and vigorous (>6). Each activity is scored by hours a day multiplied by the intensity of the activity. A higher RPAQ score indicates higher levels of physical activity.

    Measured: 12 weeks

  5. Feasibility Outcome - Interest

    Percentage of those potentially eligible who register their interest.

    Measured: 2 months

  6. Feasibility Outcome - Enrolment

    Percentage of participants that register interest enrol on the study.

    Measured: 2 months

  7. Feasibility Outcome - App Administration

    Percentage that successfully download the app.

    Measured: 3 months

  8. Feasibility Outcome - App Acceptability

    Percentage of participants who enrol and complete the 12-week study

    Measured: 3 months

  9. Feasibility Outcome - Acceptability of the Outcome Measures

    Completion levels of questionnaire

    Measured: 3 months

  10. All Cause Mortality

    Description of all cause mortality at 3 months

    Measured: 3 months

  11. Cardiovascular Events

    Description of cardiovascular events at 3 months

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start23 Aug 2023
  3. Primary completion1 Feb 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05830318
Sponsor's protocol ID
0901
Status last verified
Jun 2025
First submitted
16 Mar 2023
Last updated
1 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tonga E, Worboys H, Evans RA, Singh SJ, Davies MJ, Andre Ng G, Yates T. Physical activity guidelines for adults with type 2 Diabetes: Systematic review. Diabetes Res Clin Pract. 2025 Feb;220:111982. doi: 10.1016/j.diabres.2024.111982. Epub 2024 Dec 31.

    PubMed 39746550

  • Worboys H, Gray L, Anthony S, Hobson R, Lucas T, Ng A. Evaluation of the usability and acceptability of the P-STEP(R) mobile app: feasibility study protocol. Pilot Feasibility Stud. 2024 Sep 13;10(1):120. doi: 10.1186/s40814-024-01546-9.

    PubMed 39272125

  • Worboys HM, Gray LJ, Anthony S, Hobson R, Lucas T, Vande Hey JD, Panagi M, Ng GA. A feasibility study evaluating the usability and acceptability of the personalised space technology exercise platform mobile application. Sci Rep. 2025 Oct 17;15(1):36370. doi: 10.1038/s41598-025-20314-0.

    PubMed 41107355

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by University of Leicester at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Usability Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05830318, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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