Clinical trial NCT04074057: Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation
Official title: Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation Compared to Traditional Centre-based, Therapist Driven Cardiac Rehabilitation for Patients Post Coronary Revascularisation : A Non-inferiority Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Disease
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients who are referred for Cardiac Rehabilitation post discharge from hospital will be assessed by the Physiotherapist during the first follow-up appointment to determine eligibility for inclusion. During this session, exercise testing and a body composition analysis will be done for every patient. The Physiotherapist will then stratify all patients into low, moderate and high-risk groups only those with low and moderate risk will be included into the study after informed consent is attained. A research assistant randomise the patients into two groups, namely the intervention group or the control group. Block randomisation method will be used by using the randomisation function in Red Cap created by independent aata manager who is not part of the study team.
Primary purpose: TREATMENT

Brief summary: n Tan Tock Seng (TTSH), Acute myocardial infarction (AMI) is one of the top 4 reasons for admissions with 948 percutaneous coronary intervention (PCI) procedures done in year 2016. International guidelines recommend that all patients complete CR after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. However, the rate of completion of CR has been found to be low as only 19% of post PCI patients completed CR in 2016. According to a patient survey conducted, the main reason for non-completion is the inconvenience experienced by patients from needing to return to hospital weekly. In addition, poor compliance to prescribed home exercises limits the effectiveness of exercise training. Hence, there is a pertinent need to activate patients to engage in self-directed CR in a safe and effective manner to target these issues. Current solutions to increase participation and compliance involve strategies have been limited. Participation and compliance to prescribed exercises recorded via brochures and activity diaries have been limited by difficulties experienced by patients when providing this information, posing a risk of recall bias or the risk of misplacing their activity logs. Mobile applications targeted at increasing fitness addresses the problem of the risk of misplacing activity logs but is still subjected to recall bias as self-input of multiple data is required. Exercise guidelines within these applications are also generic and does not adhere to international exercise training guidelines targeted at patients after coronary revascularisation. In order to address these gaps, there is a need for a technology enabled solution that can provide evidence-based CR programme with constant HR monitoring which offers direct feedback to the patients and at the same time affordable and easy to use. "Heart-Track" is a novel mobile app based CR model of care that utilises a technology-enabled device designed specifically for patients post PCI to complete CR at their convenience, while ensuring that evidence-based clinical outcomes are achieved.

Detailed description: In Tan Tock Seng (TTSH), Acute myocardial infarction (AMI) is one of the top 4 reasons for admissions with 948 percutaneous coronary intervention (PCI) procedures done in year 2016. International guidelines recommend that all patients complete CR after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. However, the rate of completion of CR has been found to be low as only 19% of post PCI patients completed CR in 2016. According to a patient survey conducted, the main reason for non-completion is the inconvenience experienced by patients from needing to return to hospital weekly. In addition, poor compliance to prescribed home exercises limits the effectiveness of exercise training. Hence, there is a pertinent need to activate patients to engage in self-directed CR in a safe and effective manner to target these issues. Current solutions to increase participation and compliance involve strategies have been limited. Participation and compliance to prescribed exercises recorded via brochures and activity diaries have been limited by difficulties experienced by patients when providing this information, posing a risk of recall bias or the risk of misplacing their activity logs. Mobile applications targeted at increasing fitness addresses the problem of the risk of misplacing activity logs but is still subjected to recall bias as self-input of multiple data is required. Exercise guidelines within these applications are also generic and does not adhere to international exercise training guidelines targeted at patients after coronary revascularisation. In order to address these gaps, there is a need for a technology enabled solution that can provide evidence-based CR programme with constant HR monitoring which offers direct feedback to the patients and at the same time affordable and easy to use. "Heart-Track" is a novel mobile app based CR model of care that utilises a technology-enabled device designed specifically for patients post PCI to complete CR at their convenience, while ensuring that evidence-based clinical outcomes are achieved. The key components of "Heart-Track" are: 1. Exercise principles based on international guidelines 2. Gamification; 3. Continuous heart rate monitoring; 4. Adaptation to local context. As Heart-track is the first of its kind, being designed for use in the local context, findings from research is important in determining its efficacy when compared to traditional cardiac rehabilitation.

Eligibility criteria: Inclusion Criteria:

1. 21-65 years old
2. Underwent coronary revascularisation follow AMI
3. Language literacy English or Mandarin
4. Owns a smart phone
5. Normal physiological response during exercise testing
6. Low or moderate risk following risk stratification.

Exclusion Criteria:

1. Medically unfit for exercise
2. Post op complication
3. High risk following risk stratification
4. Cognitive impaired

Primary outcomes:
measure: 6 minutes walk test
timeFrame: through study completion, an average of 1 year
measure: Body weight
timeFrame: through study completion, an average of 1 year
measure: Body Height
timeFrame: through study completion, an average of 1 year
measure: Body Mass Index
timeFrame: through study completion, an average of 1 year
measure: Body Fat Percentage
timeFrame: through study completion, an average of 1 year
measure: Skeletal muscle mass
timeFrame: through study completion, an average of 1 year
measure: Waist Hip Ratio
timeFrame: through study completion, an average of 1 year
measure: Borg's RPE scale
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Self-Efficacy for Exercise Scale•
timeFrame: through study completion, an average of 1 year
measure: Health related QoL: MacNew myocardial infarction Quality of life questionnaire
timeFrame: through study completion, an average of 1 year
measure: Patient-reported survey on usability of Heart Track acceptability
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Senior Physiotherapist
name: Eng Chuan Neoh, masters
role: STUDY_DIRECTOR
References: