Trial Outcomes & Findings for Usability and Acceptability Study of the P-STEP Mobile Application (NCT NCT05830318)
NCT ID: NCT05830318
Last Updated: 2026-05-01
Results Overview
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.
COMPLETED
178 participants
12 weeks
2026-05-01
Participant Flow
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
This was a single arm pilot study and therefore all participants enrolled received the intervention.
Participant milestones
| Measure |
Particpants of the Study Receiving Access to the P-STEP App
First stage of inclusion criteria:
* Part of the EXCEED cohort study
* Adult ≥ 18 years
* Lives in Leicestershire
* Does not have dementia, learning disability, severe mental health disorders (other than depression or anxiety), cancer or epilepsy.
* Are not receiving palliative care
* Diagnosed with at least one of the following conditions; asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), coronary heart disease (CHD), heart failure (HF), type 2 diabetes\* \* It was agreed that given the short recruitment window, this criterion could be relaxed to include participants without LTCs if recruitment was slow.
Does:
* Can walk for a minimum of 5 minutes outside
* Have an Android smartphone
* Have access to the internet on smartphone
* Have ability to give informed consent
Does not:
* Have chest pain at rest
* Feel unsteady when standing or walking, which has led to a fall
* Are pregnant
* Are a current cancer patient
* Are receiving palliative care
* Have access to an iOS smartphone only
* Have been advised not to take part in exercise in the past 12 months
* Were part of the P-STEP User engagement group and provided PPI input.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Usability and Acceptability Study of the P-STEP Mobile Application
Baseline characteristics by cohort
| Measure |
App Arm
n=133 Participants
First stage of inclusion criteria:
* Part of the EXCEED cohort study
* Adult ≥ 18 years
* Lives in Leicestershire
* Does not have dementia, learning disability, severe mental health disorders (other than depression or anxiety), cancer or epilepsy.
* Are not receiving palliative care
* Diagnosed with at least one of the following conditions; asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), coronary heart disease (CHD), heart failure (HF), type 2 diabetes\* \* It was agreed that given the short recruitment window, this criterion could be relaxed to include participants without LTCs if recruitment was slow.
Does:
* Can walk for a minimum of 5 minutes outside
* Have an Android smartphone
* Have access to the internet on smartphone
* Have ability to give informed consent
Does not:
* Have chest pain at rest
* Feel unsteady when standing or walking, which has led to a fall
* Are pregnant
* Are a current cancer patient
* Are receiving palliative care
* Have access to an iOS smartphone only
* Have been advised not to take part in exercise in the past 12 months
* Were part of the P-STEP User engagement group and provided PPI input.
n=93
|
|---|---|
|
Age, Continuous
|
66.25 years
STANDARD_DEVIATION 8 • n=14 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
White
|
83 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
Mixed/Multiple ethnic groups
|
1 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
Asian/Asian British
|
6 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
Black/African/Caribbean/Black British
|
3 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
Missing
|
40 Participants
n=14 Participants
|
|
Long term condition(s)
Asthma
|
18 Participants
n=14 Participants
|
|
Long term condition(s)
Type 2 Diabetes
|
13 Participants
n=14 Participants
|
|
Long term condition(s)
COPD
|
4 Participants
n=14 Participants
|
|
Long term condition(s)
Heart disease
|
2 Participants
n=14 Participants
|
|
Long term condition(s)
Heart failure
|
1 Participants
n=14 Participants
|
|
Long term condition(s)
None reported
|
95 Participants
n=14 Participants
|
|
English first language (YES)
Yes
|
89 Participants
n=14 Participants
|
|
English first language (YES)
No
|
4 Participants
n=14 Participants
|
|
English first language (YES)
Not reported
|
40 Participants
n=14 Participants
|
|
Has previously attended exercise rehab program (YES)
Yes
|
3 Participants
n=14 Participants
|
|
Has previously attended exercise rehab program (YES)
No
|
69 Participants
n=14 Participants
|
|
Has previously attended exercise rehab program (YES)
Not reported
|
61 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
6-weeks
n=72 Participants
6 week SUS scores
|
12-week
n=61 Participants
12-week SUS scores
|
|---|---|---|
|
System Usability Scale
|
57.92 score on a scale
Standard Deviation 20.12
|
61.68 score on a scale
Standard Deviation 22.09
|
SECONDARY outcome
Timeframe: 12 weeksOther 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsPercentage of those potentially eligible who register their interest.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsPercentage of participants that register interest enrol on the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPercentage that successfully download the app.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPercentage of participants who enrol and complete the 12-week study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsCompletion levels of questionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsDescription of all cause mortality at 3 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsDescription of cardiovascular events at 3 months
Outcome measures
Outcome data not reported
Adverse Events
Averse Events Were Collected Relating to Non-routine GP Visits and Unexpected Hospitalisations
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Averse Events Were Collected Relating to Non-routine GP Visits and Unexpected Hospitalisations
n=93 participants at risk
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.
|
|---|---|
|
General disorders
A non-routine GP appointment due to your chronic condition
|
8.6%
8/93 • 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
|
|
General disorders
A non-routine GP appointment due to anything other than your chronic condition
|
25.8%
24/93 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place