Liverpool John Moores University
Liverpool, L3 3AF, United Kingdom
NCT Number: NCT05774587
The investigators aim to conduct a feasibility study to evaluate a model where mobile health (mHealth) technology supports a remote home-based PA and counselling intervention immediately post hospital discharge to increase uptake to cardiac rehabilitation. Our overall objective is to test the feasibility of an evidence-based complex intervention prior to evaluation in a future randomized control trial (RCT)
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Liverpool, L3 3AF, United Kingdom
The investigators will recruit 60 participants from three cardiac rehabilitation (CR) sites: Liverpool Heart and Chest NHS Foundation Trust (n=20), University Hospitals Coventry and Warwickshire NHS Trust (n=20) and North Tees and Hartlepool Foundation Trust (n=20). The participant information sheet will be added to hospital discharge packs, participants will then be contacted by the CR team immediately post-discharge as part of routine care (within 48h at our named sites). During this contact the CR team will discuss the study information. The research fellow will then contact interested participants and consent and screening will occur via video call. Written informed consent will be captured using the eSignature solution HELLOSIGN, in line with Health Regulation Authority advice.
This is a feasibility, assessor-blind, parallel group randomized control trial (RCT). Participants will be randomized and allocated to either CR standard care (control group) or exercise counselling with mHealth + CR standard care (experimental group). Assessments will be completed twice; 1) immediately post hospital discharge, before any intervention, and 2) after CR. To minimize participant burden and ensure timely completion, outcome measures will be undertaken remotely. Participants will be mailed (guaranteed next day delivery by midday) all necessary assessment resources immediately following consent. Written and video guidance on how to complete the assessments will be provided along with online support from the research fellow.
Participants will be randomised into one of two groups:
The experimental intervention will be supported by 3 mHealth elements: 1. Online coaching platform for the research fellow. Within the platform the research fellow will build the co-designed exercise programme, specifying the agreed number of sessions per week. Individual exercise sessions will be built, prescribing the duration and intensity (measured through HR) of each phase i.e., warm up, workout and cool-down. Structured exercise CR sessions will also be inserted, when CR begins, so these can be tracked. These detailed exercise sessions will then be available as pre-set sessions on the fitness tracker. Throughout the intervention the online platform will also provide the research fellow access to the participant data including; daily PA, HR during exercise, rate of perceived exertion RPE (CR-10 scale) following exercise sessions and written comments on exercise sessions. 2. Smart phone app for participants (Polar Flow). Participants will access their exercise programme and track exercise and PA achievements and provide feedback on each exercise session; including a session RPE and a written comment. 3. Wrist worn fitness tracker for participants (Polar Ignite, Polar Electro). Will act like a CR specialist on participants' wrists. The Polar Ignite fitness watch features a triaxial accelerometer and optical HR monitor. Patients can keep this kit. Participants will access pre-set exercise sessions, designed by the research fellow, on the device. The prescribed duration and intensity, via HR zones, will be displayed in real time on the watch throughout the exercise session. The watch will also provide live visual and haptic (vibration) alerts, coaching participants to execute the session as prescribed. Progress towards a personalised daily PA target will also be displayed throughout the day on the watch screen. Data from the mHealth elements, including participant comments, will be used to facilitate ongoing personalised feedback. Immediately following hospital discharge and for the 1st month of walking intervention, participants will receive text messages from the research fellow after each exercise session. For the remainder of the walking intervention (including during CR), messages will be sent weekly. Participants will be able to respond to these comments and programmes will be updated if necessary.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardiac rehab control group
Exercise and counselling through mHealth technology
Time frame: 1 year
The percentage of patients that are screened, eligible and approached
The percentage of patients that take up standard CR and reasons for drop out; and the percentage of participants that complete outcome assessments and reasons for drop out.
Time frame: Up to 27 weeks
Number of exercise sessions per week
Time frame: Up to 27 weeks
Numbers of minutes completed per session
Time frame: Up to 27 weeks
Intensity of exercise sessions performed (% of HR reserve)
Time frame: 7 days (post completion of CR programme)
Minutes of moderate or vigorous physical activity
Time frame: Up to 27 weeks
Behaviour regulation of exercise measured by 19 questions on a 5-point Likert scale (0-4) with 1 = not true to me and 4 = very true to me
Time frame: Up to 27 weeks
Weight (kg)
Time frame: Up to 27 weeks
Waist circumference (cm)
Time frame: Up to 27 weeks
Blood pressure (mmHg)
Time frame: Up to 27 weeks
Blood lipid concentrations made up of HDL mmol/L, LDL mmol/L, Triglycerides mmol/L levels
Time frame: Up to 27 weeks
MacNew heart disease questionnaire has 27 questions with 7 options as an answer, 7 being high health-related quality of life and 1 being poor health-related quality of life.
Time frame: Up to 27 weeks
Euro-Quality of life-5L questionnaire Five dimensions with five options as an answer within each one, each option is coded between 1-5 with a five digit code the outcome.
Visual scale of 0-100 with 100 being the best state and 0 being the worse state of health participants are feeling
Time frame: Up to 27 weeks
Study specific questionnaire (qualitative)
Time frame: Up to 27 weeks
Study specific questionnaire (qualitative)
Time frame: Up to 27 weeks
Patient interview
Time frame: Up to 27 weeks
Patient interview
Time frame: Up to 27 weeks
HbA1c levels measured in mmol/mol
Liverpool John Moores University
Other
Mobile Health Biometrics to Prescribe Immediate Remote Physical Activity for Enhancing Uptake to Cardiac Rehabilitation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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