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Assess the usability and acceptance of the P-STEP app, through allowing participants with specific chronic conditions to pilot the app for 12-weeks.
Participants are asked to use mobile app for 12 weeks & complete baseline, 6 week and 12 week assessments.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-STEP Mobile Application | Other | A mobile application that allows you track your walking habits while keeping you up to date with air quality information. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leicester | Leicester | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39746550 | Background | 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. | |
| 39272125 | Background | 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. |
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This was a single arm pilot study and therefore all participants enrolled received the intervention.
We recruited from a pre-existing cohort study based in Leicester, United Kingdom. Participants were recruited from the EXCEED cohort study(41). The EXCEED study (REC ref 13/EM/0226) is a longitudinal population-based cohort study that facilitates the investigation of genetic, environmental and lifestyle-related determinants of a broad range of diseases and multiple long-term conditions
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| ID | Title | Description |
|---|---|---|
| FG000 | Particpants of the Study Receiving Access to the P-STEP App | First stage of inclusion criteria:
Does:
Does not:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
178 participants were enrolled on the study, 147 gave informed consent. This gives a difference of 31 which included 27 that were lost to follow up, 2 that were duplicate consent forms, 2 that gave unsatisfactory consent.
147 gave informed consent, 133 completed the baseline questionnaire. This gives a difference of 14 which included 10 that were lost to follow up and 4 participants who realised they had a non-android phone.
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| ID | Title | Description |
|---|---|---|
| BG000 | App Arm | First stage of inclusion criteria:
Does:
Does not:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 93 people were given access to the app, 72 completed 6-week follow up. This created a difference of 21 which included 16 lost to follow up, 3 hospitalisations, 1 withdrawal due to security and 1 due to a change in circumstances. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
12 weeks
As the app is not an investigational medicinal product nor a medical device, no adverse effects are expected. Data on non-routine GP visits and unexpected hospitalisations, related or unrelated to the participant's chronic condition(s) were collected at 6 and 12 weeks, instead of adverse events. Any unexpected hospitalisations reported were treated as a potential serious adverse event (SAE) as per University of Leicester Sponsor SAE reporting policy, and followed up directly with participants to
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Averse Events Were Collected Relating to Non-routine GP Visits and Unexpected Hospitalisations | Non-routine GP visits and unexpected hospitalisations. Collected at 6 and 12 weeks. participants were asked about non-routine GP appointments relating to their condition and unrelated to their condition. Participants were also asked about hospitalisations both related and unrelaed to condition. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| A non-routine GP appointment due to your chronic condition | General disorders | Systematic Assessment |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hannah Worboys | University of Leicester | 0116 252 2522 | hmw33@leicester.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 9, 2026 | Apr 9, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D017563 | Lung Diseases, Interstitial |
| D003327 | Coronary Disease |
| D006333 | Heart Failure |
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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. | 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| Feasibility Outcome - Interest | Percentage of those potentially eligible who register their interest. | 2 months |
| Feasibility Outcome - Enrolment | Percentage of participants that register interest enrol on the study. | 2 months |
| Feasibility Outcome - App Administration | Percentage that successfully download the app. | 3 months |
| Feasibility Outcome - App Acceptability | Percentage of participants who enrol and complete the 12-week study | 3 months |
| Feasibility Outcome - Acceptability of the Outcome Measures | Completion levels of questionnaire | 3 months |
| All Cause Mortality | Description of all cause mortality at 3 months | 3 months |
| Cardiovascular Events | Description of cardiovascular events at 3 months | 3 months |
| 41107355 | Derived | 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. |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Female | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Long term condition(s) | Count of Participants | Participants |
|
| English first language (YES) | Count of Participants | Participants |
|
| Has previously attended exercise rehab program (YES) | Count of Participants | Participants |
|
| OG001 | 12-week | 12-week SUS scores |
|
|
| Secondary | 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. | Not Posted | 12 weeks | Participants |
| Secondary | 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. | Not Posted | 12 weeks | Participants |
| Secondary | 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. | Not Posted | 12 weeks | Participants |
| Secondary | 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. | Not Posted | 12 weeks | Participants |
| Secondary | Feasibility Outcome - Interest | Percentage of those potentially eligible who register their interest. | Not Posted | 2 months | Participants |
| Secondary | Feasibility Outcome - Enrolment | Percentage of participants that register interest enrol on the study. | Not Posted | 2 months | Participants |
| Secondary | Feasibility Outcome - App Administration | Percentage that successfully download the app. | Not Posted | 3 months | Participants |
| Secondary | Feasibility Outcome - App Acceptability | Percentage of participants who enrol and complete the 12-week study | Not Posted | 3 months | Participants |
| Secondary | Feasibility Outcome - Acceptability of the Outcome Measures | Completion levels of questionnaire | Not Posted | 3 months | Participants |
| Secondary | All Cause Mortality | Description of all cause mortality at 3 months | Not Posted | 3 months | Participants |
| Secondary | Cardiovascular Events | Description of cardiovascular events at 3 months | Not Posted | 3 months | Participants |
| 0 |
| 93 |
| 0 |
| 93 |
| 32 |
| 93 |
| A non-routine GP appointment due to anything other than your chronic condition | General disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |