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| Name | Class |
|---|---|
| KiActiv | UNKNOWN |
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KiCS1 study : Digital health for current hospital- based Cardiac rehabilitation programmes to increase effectiveness and patient outcomes.
Cardiac rehabilitation (CR) after a heart attack has shown to be more effective than any other medication given after such an event. It is a recommended therapy by NICE. However, only 44% of eligible patients attend rehabilitation and only half of these complete the course. Novel ways to increase uptake and compliance are needed.
In this study, calorie burn and physical activity data will be collected using a validated, CE marked physical activity monitor, herein referred to as Ki monitor. Data can be uploaded to an online behaviour change platform that incorporates personalised feedback in the context of their bespoke requirements for CR to empower people to self-care at home using their personal everyday physical activity. This can be closely monitored and support can be given on the contextualised feedback by healthcare professionals. A small pilot study has been carried out to establish wearability of a physical activity monitor in a CR cohort, which has demonstrated a high level of acceptability.
We now wish to extend this pilot to a randomised study designed to test the effectiveness of using contextualised body data to influence physical activity in a free-living environment amongst patients undergoing CR, based on the current ACPICR standards for Daily Activity and At-home Training. All patients referred for CR will be invited to take part. These will be randomised to the usual care (UC) group or the contextualised data feedback (CDF) group. Both groups will wear the Ki monitor for eight weeks. The UC group will receive usual care, the CDF group will receive usual care with the addition of contextualised feedback on their activities based on the physical activity data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Cardiac Rehabilitation | Other | Patients receive usual care and wear Ki monitor - doesn't receive any feedback during the cardiac rehabilitation period. |
|
| Intervention Arm - Usual Cardiac Rehabilitation plus contextualised Data feedback | Experimental | Patient receives usual care and also wears Ki monitor and receives contextualised data feedback |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ki Monitor without feedback | Device | Physical activity Monitor - No feedback |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achieving the ACPICR standards for physical activity in a free-living environment objectively measured using the Ki monitor | Objective measurement using Ki monitor. | 6 - 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise test result. | Incremental shuttle walk test or 6 minute walking test, as appropriate | 6-8 weeks |
| Total calories burned | Objectively measured using the Ki monitor |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life measured using the Dartmouth Coop | Participants completed a questionnaire at the start and end of the cardiac rehabilitation program. | 6-8 weeks |
| Anxiety and depression score measured using Hospital Anxiety and depression scale (HADS) |
Inclusion Criteria:
All patients referred to the cardiac rehab programme will be invited to take part in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Micheal Fisher | Liverpool University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool University Hospital NHS Foundation Trust | Liverpool | L78xp | United Kingdom |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| D000787 | Angina Pectoris |
| D009043 | Motor Activity |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Prospective, randomised, open -label study
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| Ki monitor with contextualised data feedback | Device | Physical activity monitor and feedback |
|
| 6-8 weeks |
| Completion of cardiac rehabilitation programme | Number of participants completed full cardiac rehabilitation programme. | 6-8 weeks |
Participants completed a questionnaire at the start and end of the cardiac rehabilitation program.
| 6-8 weeks |
| Body mass index measured using height and weight and combined to report in kg/m2 | Measured at the beginning and end of Cardiac rehabilitation programme | 6-8 weeks |
| Blood pressure measured and reported in mmHg | Measured before and after exercise tests at the beginning and end of the cardiac rehabilitation programme | 6- 8 weeks |
| Blood Glucose measured and reported in mmol/L | Measured at the beginning and end of Cardiac rehabilitation programme where appropriate | 6-8 weeks |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |