Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation

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

Sponsoren

Hauptsponsor: Tan Tock Seng Hospital

Quelle Tan Tock Seng Hospital
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Recruiting
Anfangsdatum May 1, 2019
Fertigstellungstermin May 31, 2020
Primäres Abschlussdatum May 31, 2020
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
6 minutes walk test through study completion, an average of 1 year
Body weight through study completion, an average of 1 year
Body Height through study completion, an average of 1 year
Body Mass Index through study completion, an average of 1 year
Body Fat Percentage through study completion, an average of 1 year
Skeletal muscle mass through study completion, an average of 1 year
Waist Hip Ratio through study completion, an average of 1 year
Borg's RPE scale through study completion, an average of 1 year
Sekundäres Ergebnis
Messen Zeitfenster
Self-Efficacy for Exercise Scale• through study completion, an average of 1 year
Health related QoL: MacNew myocardial infarction Quality of life questionnaire through study completion, an average of 1 year
Patient-reported survey on usability of Heart Track acceptability through study completion, an average of 1 year
Einschreibung 34
Bedingung
Intervention

Interventionsart: Other

Interventionsname: Conventional Cardiac Rehab Classes

Beschreibung: conventional weekly CR programme lasting 8-12 sessions.

Armgruppenetikett: Control arm

Interventionsart: Device

Interventionsname: Heart Track

Beschreibung: Key components of "Heart-Track" are a heart rate sensor, a mobile app and a remote monitoring portal. The "Heart-Track" mobile app is synchronized/ connected to Polar heart rate sensor through bluetooth in order to provide continous heart rate monitoring when subjects are exercising. This is to ensure safety and exercise effectiveness.

Armgruppenetikett: Intervention arm

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 21 Years

Maximales Alter: 65 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Eng Chuan Neoh, masters Study Director Senior Physiotherapist
Gesamtkontakt

Nachname: Eng Chuan Neoh, Masters

Telefon: 91733222

Email: [email protected]

Ort
Einrichtung: Status: Kontakt: Tan Tock Seng Hospital Eng Chuan Neoh, masters 91733222 [email protected]
Standort Länder

Singapore

Überprüfungsdatum

August 2019

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Tan Tock Seng Hospital

Vollständiger Name des Ermittlers: Eng Chan Neoh

Ermittlertitel: Senior Physiotherapist

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Control arm

Art: Other

Beschreibung: the control group will undergo a conventional weekly CR programme lasting 8-12 sessions. Components of each session will include warm up, aerobic training, resistance exercises and cool down. Patients are encouraged to continue their home exercises, exercising another 2 times a week at home and record down using an activity diary. The importance of CR programme and exercise advice will be explained and reinforced by the CR Physiotherapist. The submaximal exercise test and a body composition analysis will be repeated on the final assessment. Every week research coordinator will call the subject to remind them to exercise.

Etikette: Intervention arm

Art: Other

Beschreibung: During the initial assessment, the importance of CR and regular exercise will be explained and reinforced by CR physiotherapist. A research assistant will teach the patient how to use "Heart Track". The patient will then bring "Heart Track" home to continue their CR program. Patient will then undergo the whole CR programme to exercise for 3 times a day for 8-12 weeks using "Heart Track". Each "Heart Track" session will include warm up, aerobic training, resistance exercises and cool down (same as the traditional CR session). After 8-12 weeks, patient will be called back to the clinic by the research assistant to complete the final assessment (sub-maximal exercise test and a body composition analysis) with the blinded assessor. Every week research coordinator will call the subject to remind them to exercise.

Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Beschreibung des Interventionsmodells: 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.

Hauptzweck: Treatment

Maskierung: Double (Investigator, Outcomes Assessor)

Maskierungsbeschreibung: Randomization and group allocation are done by the research coordinator. Final assessment is also arranged by research coordinator. Blinded assessor will conduct the final assessment

Quelle: ClinicalTrials.gov