Usability and Acceptability Study of the P-STEP Mobile Application

Asthma Clinical Trial

Official title:

Usability and Acceptability Study of the P-STEP Mobile Application

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830318
• Other study ID #: 0901
• Status: Recruiting
• Start date: August 23, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2023
• Source: University of Leicester
• Contact: Andre Ng
• Phone: 0116 2502438
• Email: andre.ng[@]leicester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: January 31, 2024
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Heart Failure
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Myocardial Ischemia
• Pulmonary Disease, Chronic Obstructive
• Type 2 Diabetes

Intervention

Other:
• P-STEP Mobile Application
A mobile application that allows you track your walking habits while keeping you up to date with air quality information.

Locations

Country	Name	City	State
United Kingdom	University of Leicester	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 weeks
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.	12 weeks
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.	12 weeks
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.	12 weeks
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.	12 weeks
Secondary	Feasibility outcome - Interest	Percentage of those potentially eligible who register their interest.	2 months
Secondary	Feasibility outcome - Enrolment	Percentage of participants that register interest enrol on the study.	2 months
Secondary	Feasibility outcome - App administration	Percentage that successfully download the app.	3 months
Secondary	Feasibility outcome - App acceptability	Percentage of participants who enrol and complete the 12-week study	3 months
Secondary	Feasibility outcome - Acceptability of the outcome measures	Completion levels of questionnaire	3 months
Secondary	All cause mortality	Description of all cause mortality at 3 months	3 months
Secondary	Cardiovascular events	Description of cardiovascular events at 3 months	3 months