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Usability and Acceptability Study of the P-STEP Mobile Application

Study Purpose

Assess the usability and acceptance of the P-STEP app, through allowing participants with specific chronic conditions to pilot the app for 12-weeks.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05830318
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Leicester
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Asthma, Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Coronary Heart Disease, Heart Failure, Type 2 Diabetes

Additional Details

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.