Usability and Acceptability Study of the P-STEP Mobile Application

April 10, 2026 updated by: University of Leicester
Assess the usability and acceptance of the P-STEP app, through allowing participants with specific chronic conditions to pilot the app for 12-weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
User Engagement Scale Short Form
Time Frame: 12 weeks
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.
12 weeks
SF-12 Health Questionnaire
Time Frame: 12 weeks
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.
12 weeks
Recent Physical Activity Questionnaire
Time Frame: 12 weeks
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.
12 weeks
Usability of P-STEP App
Time Frame: 12 weeks
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.
12 weeks
Feasibility Outcome - Interest
Time Frame: 2 months
Percentage of those potentially eligible who register their interest.
2 months
Feasibility Outcome - Enrolment
Time Frame: 2 months
Percentage of participants that register interest enrol on the study.
2 months
Feasibility Outcome - App Administration
Time Frame: 3 months
Percentage that successfully download the app.
3 months
Feasibility Outcome - App Acceptability
Time Frame: 3 months
Percentage of participants who enrol and complete the 12-week study
3 months
Feasibility Outcome - Acceptability of the Outcome Measures
Time Frame: 3 months
Completion levels of questionnaire
3 months
All Cause Mortality
Time Frame: 3 months
Description of all cause mortality at 3 months
3 months
Cardiovascular Events
Time Frame: 3 months
Description of cardiovascular events at 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leicester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0901 (Ethikkommision KiKli BE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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