NCT05830318

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

March 16, 2023

Results QC Date

January 14, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

ExercisePollutionAir Quality

Outcome Measures

Primary Outcomes (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.

    12 weeks

Secondary Outcomes (11)

  • Usability of P-STEP App

    12 weeks

  • User Engagement Scale Short Form

    12 weeks

  • SF-12 Health Questionnaire

    12 weeks

  • Recent Physical Activity Questionnaire

    12 weeks

  • Feasibility Outcome - Interest

    2 months

  • +6 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Chest pain at rest
  • Unsteady when standing or walking
  • Current cancer patient
  • Part of the P-STEP User Engagement group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leicester

Leicester, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 39746550BACKGROUND
  • 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.

    PMID: 39272125BACKGROUND
  • 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.

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveLung Diseases, InterstitialCoronary DiseaseHeart FailureDiabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Limitations and Caveats

This study did not appeal greatly to individuals in this cohort. There are a number of possible reasons for this. Firstly, there may be a reluctance in this cohort to take part in app studies for a number of reasons including confidence using technology and security concerns in testing an app in the investigational stages of development. The time of year of the study may have also affected take up. The study ran from September to January, bad weather

Results Point of Contact

Title
Hannah Worboys
Organization
University of Leicester

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2023

First Posted

April 26, 2023

Study Start

August 23, 2023

Primary Completion

February 1, 2024

Study Completion

March 31, 2024

Last Updated

May 1, 2026

Results First Posted

May 1, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations