NCT05774587

Brief 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. Our overall objective is to test the feasibility of an evidence-based complex intervention prior to evaluation in a future randomized control trial (RCT)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 6, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 15, 2025

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

February 21, 2023

Last Update Submit

May 12, 2025

Conditions

Cardiac Event

Keywords

HealthRehabilitation

Outcome Measures

Primary Outcomes (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.

    1 year

Secondary Outcomes (16)

  • Device derived adherence to structured exercise

    Up to 27 weeks

  • Device derived duration of structured exercise

    Up to 27 weeks

  • Device derived intensity of structured exercise

    Up to 27 weeks

  • Device derived physical activity adherence (GENEActiv)

    7 days (post completion of CR programme)

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

    Up to 27 weeks

  • +11 more secondary outcomes

Study Arms (2)

Active control

ACTIVE COMPARATOR

Participants will complete a 3-month cardiac rehabilitation programme supported by the onsite CR service

Behavioral: mHealth control group

mHealth technology assisted exercise counselling (mHealth)

EXPERIMENTAL

Participants 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.

Behavioral: mHealth technology assisted exercise counselling (mHealth)

Interventions

mHealth control groupBEHAVIORAL

Cardiac rehab control group

Active control
mHealth technology assisted exercise counselling (mHealth)BEHAVIORAL

Exercise and counselling through mHealth technology

mHealth technology assisted exercise counselling (mHealth)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, L3 3AF, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38346877DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Helen Jones

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 17, 2023

Study Start

July 6, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

May 15, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

No plan to share

Locations

GB(1)