Usability and Acceptability Study of the P-STEP Mobile Application

Sponsor

University of Leicester (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05830318

Collaborator

(none)

380

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Chronic Obstructive Pulmonary Disease Interstitial Lung Disease Coronary Heart Disease Heart Failure Type 2 Diabetes	Other: P-STEP Mobile Application

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

380 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Usability and Acceptability Study of the P-STEP Mobile Application

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Outcome Measures

Primary Outcome Measures

System Usability Scale [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.

Secondary Outcome Measures

Usability of P-STEP app [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.
User Engagement Scale Short Form [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.
SF-12 Health Questionnaire [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.
Recent Physical Activity Questionnaire [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.
Feasibility outcome - Interest [2 months]
Percentage of those potentially eligible who register their interest.
Feasibility outcome - Enrolment [2 months]
Percentage of participants that register interest enrol on the study.
Feasibility outcome - App administration [3 months]
Percentage that successfully download the app.
Feasibility outcome - App acceptability [3 months]
Percentage of participants who enrol and complete the 12-week study
Feasibility outcome - Acceptability of the outcome measures [3 months]
Completion levels of questionnaire
All cause mortality [3 months]
Description of all cause mortality at 3 months
Cardiovascular events [3 months]
Description of cardiovascular events at 3 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 from April - August 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