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Cardiac EventNCT05774587

Mobile Health for Cardiac Rehabilitation (Motivate-CR+)

A study testing mHealth technology assisted exercise counselling (mHealth) in people with Cardiac Event, run by Liverpool John Moores University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Event
What is being tested?
mHealth technology assisted exercise counselling (mHealth)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteUnited Kingdom
Study dates
6 Jul 2023to 1 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female
  • Over 18 years old
  • Post myocardial infarction (MI)
  • Post percutaneous coronary intervention (PCI) patients
  • Referred for CR

Who cannot join

  • Unable to participate in self-management programmes because of medical care needs,
  • Absolute contraindications to exercise
  • Unable to operate or own mobile/smartphone devices
  • Declined CR standard care
  • Allergies to the watch materials
  • Atrial fibrillation or other arrhythmia preventing accurate heart rate

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Liverpool John Moores University

    Liverpool, L3 3AF

Other trials in United Kingdom

About this study

Official title: Mobile Health Biometrics to Prescribe Immediate Remote Physical Activity for Enhancing Uptake to Cardiac Rehabilitation

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)

Read the detailed description

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:

  1. CR standard care control group: Participants will follow CR standard care and have contact (e.g. telephone/virtual and/or home visit) with the CR team between discharge and beginning CR. Participants will begin structured exercise at the time provided by the CR service, the structured exercise service consists of 1-2 supervised exercise sessions per week for 12 weeks at the clinical or community centre. Exercise sessions are circuit-based, cardiovascular and strength exercise of light to moderate intensity (40-70% heart rate reserve). Participants can wear an unblinded HR monitor during structured exercise provided by the CR service. As part of the study, they will also always wear a blinded optical HR monitor. Patients can keep this kit if you wish or return it to us using a pre-paid envelope. This monitor provides no feedback to participants but provides exercise intensity and adherence data to the research team remotely. Thus, participants will wear 2 watches during CR sessions to receive feedback on HR as would be the case during standard CR, but only 1 blinded watch outside CR, wear during incidental exercise/PA, as part of the study.
  2. Exercise counselling with mHealth +CR standard care experimental group: Participants will co-design a personalised and progressive home-based walking program, with support from the research fellow, that starts immediately following hospital discharge and continues as an adjunct once structured exercise CR begins. Each participant's exercise program will differ, but the aim will be to increase exercise intensity and duration throughout the programme with the goal of achieving 150-minutes of moderate intensity exercise per week, when combined with structured exercise CR sessions. To assist with the transition to independent exercise and to promote long-term adherence, participants will receive 4 virtual exercise counselling sessions. The first, held within 5 days of discharge, will be used to assess current beliefs/concerns, explore the benefits of exercise and agree on a SMART (specific, measurable, achievable, relevant and time-bound) PA plan. During this initial phase, participants will be prescribed an individualised (initial duration and intensity of sessions and rate of progression) walking plan. Once structured exercise CR has begun, a second session will be held to discuss progress and refine goals with the aim of progressing the programme. At this time, home-based sessions will be performed alongside structured exercise CR sessions to increase adherence in daily life. A third meeting will be held 1 month into CR to discuss progress. A final meeting will occur at the end of CR to review progress and strategies to maintain exercise and PA. The mHealth technology supported PA and counselling intervention, MOTIVATE, is informed by social cognitive theory. An analysis of the intervention components show MOTIVATE sessions have an emphasis on behaviour change technique categories, including "Goals and Planning," and "Feedback and Monitoring" and motivational interviewing technique processes, including "Engaging" and "Evoking" designed to promote long-term adherence to PA and exercise.

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.

Conditions
Cardiac Event
Being tested
mHealth control group, mHealth technology assisted exercise counselling (mHealth)
Keywords
Health, Rehabilitation
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth control groupBehavioural

    Cardiac rehab control group

  • mHealth technology assisted exercise counselling (mHealth)Behavioural

    Exercise and counselling through mHealth technology

Study groups in NCT05774587
Study groupRoleWhat they receive
Active controlActive comparatorParticipants will complete a 3-month cardiac rehabilitation programme supported by the onsite CR service
Receives: Behavioral: mHealth control group
mHealth technology assisted exercise counselling (mHealth)ExperimentalParticipants will complete a walking mHealth technology assisted exercise counselling intervention. All participants will have 4 exercise consultations with their exercise specialist. The intervention will be supported by 3 mHealth elements; 1) a wrist worn fitness watch, 2) a smartphone app for patients, and 3) a coaching website for the exercise specialist. The 3 elements will be synced, allowing data to be transferred between platforms.
Receives: Behavioral: mHealth technology assisted exercise counselling (mHealth)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients screened, eligible and approached

    The percentage of patients that are screened, eligible and approached

    1. decline CR (including reasons for declining)
    2. agree to CR and
    3. consent to being part of the study

    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.

    Measured: 1 year

Secondary outcomes (16)
  1. Device derived adherence to structured exercise

    Number of exercise sessions per week

    Measured: Up to 27 weeks

  2. Device derived duration of structured exercise

    Numbers of minutes completed per session

    Measured: Up to 27 weeks

  3. Device derived intensity of structured exercise

    Intensity of exercise sessions performed (% of HR reserve)

    Measured: Up to 27 weeks

  4. Device derived physical activity adherence (GENEActiv)

    Minutes of moderate or vigorous physical activity

    Measured: 7 days (post completion of CR programme)

  5. Change in self-reported exercise behaviour via the Behaviour Regulation in Exercise Questionnaire - 2 (BREQ-2)

    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

    Measured: Up to 27 weeks

  6. Weight

    Weight (kg)

    Measured: Up to 27 weeks

  7. Waist circumference

    Waist circumference (cm)

    Measured: Up to 27 weeks

  8. Blood pressure

    Blood pressure (mmHg)

    Measured: Up to 27 weeks

  9. Blood lipid concentrations

    Blood lipid concentrations made up of HDL mmol/L, LDL mmol/L, Triglycerides mmol/L levels

    Measured: Up to 27 weeks

  10. Health-related quality of life

    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.

    Measured: Up to 27 weeks

  11. Economic data completeness

    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

    Measured: Up to 27 weeks

  12. Patient qualitative survey on intervention acceptability

    Study specific questionnaire (qualitative)

    Measured: Up to 27 weeks

  13. Patient qualitative survey on testing acceptability

    Study specific questionnaire (qualitative)

    Measured: Up to 27 weeks

  14. Patient interview to assess intervention acceptability

    Patient interview

    Measured: Up to 27 weeks

  15. Patient interview to assess testing acceptability

    Patient interview

    Measured: Up to 27 weeks

  16. HbA1c

    HbA1c levels measured in mmol/mol

    Measured: Up to 27 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2023
  2. Study start6 Jul 2023
  3. Primary completion1 May 2025
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment randomized control trial
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05774587
Sponsor's protocol ID
MOTIVATE-CR+
Status last verified
Oct 2024
First submitted
21 Feb 2023
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share

Publications

  • Crozier A, Cocks M, Hesketh K, Miller G, Mcgregor G, Thomas L, Jones H. Mobile health biometrics to prescribe immediate remote physical activity for enhancing uptake to cardiac rehabilitation (MOTIVATE-CR+): protocol for a randomised controlled feasibility trial. BMJ Open. 2024 Feb 12;14(2):e076734. doi: 10.1136/bmjopen-2023-076734.

    PubMed 38346877

Questions about this trial

What is this clinical trial studying?

A study testing mHealth technology assisted exercise counselling (mHealth) in people with Cardiac Event, run by Liverpool John Moores University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients screened, eligible and approached (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05774587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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