Feasibility of the "Heart-track" Rehabilitative Device Prototype

NCT ID: NCT04059627

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2018-09-30

Brief Summary

Abstract Title: "Heart-track" cardiac rehabilitation device prototype designed for exercise training post coronary revascularisation: A usability study Background: Percutaneous Coronary Intervention (PCI) is a common surgical procedure for heart attack patients. International guidelines recommend that all patients complete phase two (outpatient) cardiac rehabilitation (CR) after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. Patients in our institution have suboptimal exercise compliance and effectiveness during cardiac rehabilitation. Root cause analysis identified 'lack of commitment', 'lack of care monitoring and continuity' and 'lack of motivation and engagement' to be key contributing factors. Yet, healthcare resource limitations necessitate innovation for care continuity and patient engagement. "Heart-track", a novel, app-based innovation was created. By 'game-ifying' cardiac rehabilitative exercise training program, "Heart-track" guides and tracks cardiac rehabilitation at home at patient's comfort.

Purpose: To explore experiences of app usability in terms of content, functionality and design of the prototype "Heart-track" app to improve user experience.

Methods: Twelve community-dwelling adults who are also active member of cardiac rehab support group, aged above 50, and undergone coronary revascularisation for acute myocardial infarction at least 1 year before were recruited. Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app. Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. Descriptive analysis of quantitative responses were analysed using IBM SPSS software version 19.0 (Armonk, NY: IBM Corp).

Detailed Description

Abstract Title: "Heart-track" cardiac rehabilitation device prototype designed for exercise training post coronary revascularisation: A usability study Background: Percutaneous Coronary Intervention (PCI) is a common surgical procedure for heart attack patients. International guidelines recommend that all patients complete phase two (outpatient) cardiac rehabilitation (CR) after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. Patients in our institution have suboptimal exercise compliance and effectiveness during cardiac rehabilitation. Root cause analysis identified 'lack of commitment', 'lack of care monitoring and continuity' and 'lack of motivation and engagement' to be key contributing factors. Yet, healthcare resource limitations necessitate innovation for care continuity and patient engagement. "Heart-track", a novel, app-based innovation was created. By 'game-ifying' cardiac rehabilitative exercise training program, "Heart-track" guides and tracks cardiac rehabilitation at home at patient's comfort.

Purpose: To explore experiences of app usability in terms of content, functionality and design of the prototype "Heart-track" app to improve user experience.

Methods: Twelve community-dwelling adults who are also active member of cardiac rehab support group, aged above 50, and undergone coronary revascularisation for acute myocardial infarction at least 1 year before were recruited. Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app. Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. Descriptive analysis of quantitative responses were analysed using IBM SPSS software version 19.0 (Armonk, NY: IBM Corp).

Conditions

Cardiac Infarct; Cardiac Event

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental arm

Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app.

Group Type: EXPERIMENTAL

Heart Track

Intervention Type: DEVICE

Description of the device: Wearable heart rate sensors are used in Heart-track, and a receiver on a smartphone app. Real-time wireless heart rate data is sent to paired mobile device with a wireless distance of up to 10m. The sensor is able to monitor a heart rate range of 30 to 240 beats per minute.

Another component of Heart-track is a "Heart-track" mobile app which captures and reflect real-time heart rate from the heart rate sensor. The mobile app also includes warm-up and cool down exercises that are gamified and supported on a smart-phone running on Android or iOS platforms.

The HR sensor will be purchased by our collaborator, Immersive Play Pte Ltd.

Interventions

Heart Track

Description of the device: Wearable heart rate sensors are used in Heart-track, and a receiver on a smartphone app. Real-time wireless heart rate data is sent to paired mobile device with a wireless distance of up to 10m. The sensor is able to monitor a heart rate range of 30 to 240 beats per minute.

Another component of Heart-track is a "Heart-track" mobile app which captures and reflect real-time heart rate from the heart rate sensor. The mobile app also includes warm-up and cool down exercises that are gamified and supported on a smart-phone running on Android or iOS platforms.

The HR sensor will be purchased by our collaborator, Immersive Play Pte Ltd.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Minimum 21 to 65 years of age
• conversational fluency in English
• undergone coronary revascularisation for acute myocardial infarction within last 5 years
• last documented ejection fraction of at least 40%
• completed a minimum of eight supervised CR sessions
• exercises at least once a week for a minimum duration of thirty minutes
• at least 6 months' experience using a smartphone
• recent experience(at least one months' experience) with any mobile app
• displaying capacity for self-monitoring and entering data.

Exclusion Criteria

-Abnormal physiological response during exercise

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tan Tock Seng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eng Chan Neoh

Senior Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eng Chuan Neoh, masters

Role: STUDY_DIRECTOR

Senior Physiotherapist

Locations

Tan Tock Seng Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2018/00307

Identifier Type: -

Identifier Source: org_study_id